January-February 2020 Regulatory Update

These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from January 1 through February 29, 2020. Please contact Leah Ziemba, Paul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

 

The January-February Regulatory Update includes several MUST READ updates:

FDA AND USDA UPDATES

  • FDA Reopens Comment Period for Proposed Rule on Food Standards of Identity Modernization MUST READ
  • FDA Small Entity Compliance Guide for Final Rule on Food Labeling MUST READ
  • FSIS Seeks Comments on Salmonella Petition MUST READ
  • FDA Extends Comment Period for Proposed Rule on Laboratory Accreditation for Food Analyses

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • FDA Final Draft Guidance for Intentional Adulteration Rule MUST READ
  • FDA Commissioners Reflect on Current Initiatives and 2020 Goals

OTHER DEVELOPMENTS OF INTEREST

  • FDA Releases Results of Surveillance Sampling in Produce, Herbs, Processed Avocado, and Guacamole
  • FDA Monitors Intentional Genomic Alterations in Animals, Signals Upcoming Public Education Campaign
  • New FSIS Administrator Appointed

FDA AND USDA UPDATES

FDA Reopens Comment Period for Proposed Rule on Food Standards of Identity Modernization
FDA is seeking additional public comment on a long dormant rulemaking establishing general principles for the agency to consider when modernizing food standards of identity. Originally published in May 2005, the proposed rule (“Food Standards; General Principles and Food Standards Modernization,” 70 Fed. Reg. 29,214) would establish a set of 13 general principles for food standards that FDA and USDA “will use in considering whether a petition to establish, revise, or eliminate a food standard,” according to the FDA announcement.

FDA has reopened the comment period to gather new information on FDA-specific aspects of the 2005 proposed rule, given the considerable technological changes that have occurred since its publication. To ensure consideration by the agency, comments on the proposed rule must be submitted by April 21, 2020.

Read the FDA announcement here, FDA’s Constituent Update here, and the proposed rule here.

FDA Releases Small Entity Compliance Guide for Final Rule on Food Labeling
FDA released a small entity compliance guide to facilitate compliance with the 2016 rule updating the Nutrition and Supplement Facts labels. The rule updated FDA’s requirements for nutrition label information, including the required declaration of certain nutrients; Daily Reference Values and Reference Daily Intake values; nutrient reference values for children under 4 years of age and for pregnant and lactating women; and the appearance of the Nutrition Facts label.

Read the FDA announcement of the guidance here. Access the guidance here.

FSIS Seeks Comments on Salmonella Petition
In January 2020, FSIS received a citizen petition to issue an interpretive rule declaring 31 different Salmonella serotypes, either jointly or individually, as per se adulterants in meat and poultry items. According to the petition, “Such an act furthers the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act’s (PPIA) goals to protect the health and welfare of consumers by encouraging the meat and poultry industry to engage in more effective oversight measures and create and implement effective preventative measures.” The petition was filed by Seattle trial lawyer Bill Marler, who represented hundreds of plaintiffs in the aftermath of the Jack in the Box E. coli outbreak in the 1990s. FSIS has invited comments on the petition.

To ensure consideration by the agency, comments on the proposed rule must be submitted by March 23, 2020.

Read USDA’s Constituent Update here. Access the Salmonella petition here.

FDA Extends Comment Period for Proposed Rule on Laboratory Accreditation for Food Analyses
FDA extended the comment period on “Laboratory Accreditation for Analyses of Foods” (84 FR 59452), a proposed rule published in November 2019. The proposed rule aims to “establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act,” to certify that food testing undergoes proper oversight and meets model standards.

To ensure consideration by the agency, comments on the proposed rule must be submitted by April 6, 2020.

Read the FDA announcement here and the proposed rule here.


FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Releases Final Draft Guidance Installment for Intentional Adulteration Rule
FDA released the third and final installment of its draft guidance for compliance with FSMA’s Intentional Adulteration (IA) Rule, which concerns dangerous elements intentionally introduced to foods to harm public health. The draft guidance will help food facilities registered under the Federal Food, Drug, and Cosmetic Act to instate risk-reducing strategies.

According to FDA’s Constituent Update, “This last installment of the IA rule draft guidance adds to the previously published draft guidance with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping.”

To ensure consideration by the agency, comments on the draft guidance must be submitted by June 15, 2020. Read the FDA announcement here and FDA’s Constituent Update here. Learn more about the IA rule here.

FDA Commissioners Reflect on Current Initiatives and 2020 Goals
In an “FDA Voices” article, Frank Yiannas (Deputy Commissioner for Food Policy and Response) and Judy McMeekin (Acting Associate Commissioner for Regulatory Affairs) summarized ongoing FDA initiatives and their goals for FDA in 2020.

At the start of January, FDA and its state regulatory partners were finishing the first year of routine inspections of large farms under FSMA’s Produce Safety Rule and were about to start their first routine inspections of small farms. Yiannas and McMeekin commended FDA’s collaboration with the National Association of State Departments of Agriculture (NASDA) to prepare farmers to comply with this rule.

Yiannas and McMeekin also addressed efforts to create more flexible and practical agricultural water standards, the “FDA Strategy for the Safety of Imported Foods,” microbiological surveillance sampling to prevent foodborne illness, and the future of produce safety, which they argued hinges on “remain[ing] laser-focused on prevention to help bend the curve of foodborne illness.” Read the “FDA Voices” article here and the FDA Strategy for the Safety of Imported Food here. Learn more about the Produce Safety Rule here.


OTHER DEVELOPMENTS OF INTEREST

Produce, Herbs, Avocado & Guacamole
In January, FDA released an update on its sampling of frozen strawberries, raspberries, and blackberries for hepatitis A virus and norovirus, an assignment begun in November 2018. Of the 339 domestic and 473 import samples of frozen berries tested, five samples contained genetic material from hepatitis A virus, and eight samples contained genetic material from norovirus. Read FDA’s Constituent Update on frozen berry sampling here.

In February, FDA released an update on its sampling of fresh herbs (cilantro, parsley, and basil), processed avocado, and guacamole for certain microbial contaminants, a large-scale assignment begun in February 2018. FDA was unable to draw conclusions regarding the fresh herb samples and had begun analysis of the processed avocado and guacamole samples for publication in the final report. Read FDA’s Constituent Update on fresh herb, guacamole, and processed avocado sampling here.

FDA Monitors Intentional Genomic Alterations in Animals, Signals Upcoming Public Education Campaign
FDA Commissioner Stephen Hahn, M.D. issued a statement about ongoing FDA efforts to oversee intentional genomic alterations in animals, such as genome editing, and “to ensure that the intentional genomic alterations in animals are safe for the animal, safe for people eating food products from the animal and that the alteration does what it’s intended to do.” Hahn also announced an upcoming public education campaign to inform the public about agricultural biotechnology products. Read the FDA statement here.

New FSIS Administrator Appointed
In February, Paul Kiecker was appointed Administrator of FSIS to assume the role of Carmen Rottenberg, who had served as Administrator since May 2018. Kiecker has worked with FSIS for 30 years, at one point serving as Deputy District Manager and District Manager in Madison, Wisconsin. Read the USDA press release here.

 

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