November 19, 2018

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Pacing the halls for details of Bioengineered labeling requirements

Join those who are anxiously pacing the halls because USDA proposed “bioengineered food” or “BE” term could replace “GMO”.  Timing of this “BE” labeling disclosure (requirements) will coincide with the FDA’s compliance date for nutrition facts and supplement facts changes.

December 1, 2018 looms as one of several major announcements for labeling rules in both the food and supplement industries.  That date marks the expected announcement of the USDA’s decision for how and what to label genetically engineered content of foods (and supplements).  This becomes the federal requirement to disclose “GMO” content on a majority of American foods, including those imported to the USA.  It was signed in 2016 as a replacement for the state-by-state requirements (like Vermont’s GMO law).

Watch the federal review progress at the Office of Management & Budget’s dashboard.

 

 

September 5, 2018

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Nominations open to 2020-25 Dietary Guidelines Advisory Committee

Professionals are sought for federal committee to shape food and nutrition policies. USDA and the Department of Health & Human Services are seeking nominations for the committee developing the 2020-25 Dietary Guidelines for Americans.  This committee is expected to start Fall 2018/Winter2019 and meet 5 times.  Its duties will be to establish more of a framework for federal nutrition programs, particularly the nutrient needs for pregnant women and children from birth to 24 months.

The role is an independent, science-based advisory role.  Historically the committee has had challenges finding industry-experienced experts.

Applications Due By: October 6, 2018

Pre-publication details announced in Federal Register. http://s3.amazonaws.com/public-inspection.federalregister.gov/2018-19302.pdf

Additional information about the Committee is available at
http://www.dietaryguidelines.gov

The September 5, 2018 USDA Press Release, titled “Nominations now open for the 2020 Dietary Guidelines Advisory Committee”, is posted at
http://www.usda.gov/media/press-releases/2018/09/05/nominations-now-open-2020-dietary-guidelines-advisory-committee

 

May 9, 2018

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Federal Organic and GMO labeling rules proposed by USDA

 

The United States Department of Agriculture released its proposed rules for declaring “bio-engineered food ingredient” content on most foods that are not organically certified. The required disclosure will a federally mandated message rather than a warning, as is the case of with high risk products.

 

Industry and consumers only have until July 3, 2018 to make comments to the proposed rules–with no hope of an extension. USDA has set compliance dates to coincide with the FDA’s new nutrition facts and supplement facts label updates: January 1, 2020 (or 2021 for small manufacturers).

 

Comments are requested by the USDA regarding which disclosures are most suitable and if “TWO pre-approved lists of agricultural crops” make the most practical sense for designation of “b-e” foods and “b-e” food ingredients. The lists would be updated periodically and USDA is seeking comments on this practicality, too.

 

Comments may be submitted online through the Federal eRulemaking portal www.regulations.gov beginning Friday May 4. Comments may also be filed with the Docket Clerk, 1400 Independence Ave., SW, Room 4543-South, Washington, DC 20250; Fax: (202) 690-0338.

The deadline for comments is July 3, 2018

 

The USDA is proposing disclosures on packages –similar to the National Organic Program regulations–in the form of:

  1. logos,
  2. phone numbers that may receive text messages,
  3. electronic codes, or
  4. a designated phrase

The disclosure will not use the popular terms “Genetically Modified Organism” or “GMO”. Rather the USDA believes “bio-engineered” is a more realistic  term to comply to the law signed in 2016. This was the federal law enacted to avert a state-by-state patchwork of GMO-labeling laws.

 

 

The National Bioengineered Food Disclosure Standard Law was enacted by Congress on July 29, 2016. The proposed rule previewed in the May 3, Federal Register.

January 21, 2018

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Planned Food Regulations for 2018

The Federal Government, publishes their Regulatory Agenda’s semi-annually. This Fall’s 2017 agenda has been published  January 12, 2018 Federal Register – “The agenda describes the regulatory and deregulatory actions that are under development or recently completed for each agency.” The complete agenda can be found on reginfo.gov.

For your convenience, KnowledgeBank is filtered the list, to show only regulations impacting the Food and Supplement Industry

 

Agency Agenda Stage of Rulemaking Title RIN
HHS/FDA Proposed Rule Stage Laboratory Accreditation for Analyses of Foods 0910-AH31
HHS/FDA Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease 0910-AH43
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH61
HHS/FDA Proposed Rule Stage Updating Public Information Regulations 0910-AH69
HHS/FDA Proposed Rule Stage Revision of Product Jurisdiction Regulations 0910-AH71
HHS/FDA Proposed Rule Stage The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules 0910-AH77
HHS/FDA Proposed Rule Stage Suspension of Registration of Food Facilities 0910-AH79
HHS/FDA Proposed Rule Stage Permanent Listing of Color Additive Lakes 0910-AH80
HHS/FDA Proposed Rule Stage Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size 0910-AH83
HHS/FDA Proposed Rule Stage Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AH89
HHS/FDA Proposed Rule Stage Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and E 0910-AH92
HHS/FDA Proposed Rule Stage Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E 0910-AH93
HHS/FDA Final Rule Stage Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
HHS/FDA Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 0910-AH00
USDA/AMS Proposed Rule Stage National Bioengineered Food Disclosure Standard 0581-AD54
USDA/AMS Proposed Rule Stage NOP; National List Amendments, Proposed Rule 0581-AD60
USDA/AMS Proposed Rule Stage NOP: Organic Livestock and Poultry Practices 0581-AD75
USDA/AMS Final Rule Stage NOP; Organic Livestock and Poultry Practices 0581-AD44
USDA/FNS Final Rule Stage Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements 0584-AE53

September 11, 2017

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The Paradox of Federal Paperwork Reduction – Your Chance to Be Heard!

Few real paradoxes exist. Is it the Chicken or the Egg?

 

The federal government has no problem with paradoxes. The government passed laws (or rather an executive order), and thus increased the paperwork.  Ironically this executive order aims to reduce paperwork.

 

Once again the adage, that you have to move backwards to move forward applies. In this case, it is a very good thing.

 

It’s your chance to be heard. Specifically the FDA and USDA are  formally “seeking seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.”

Here is the FDA and USDA’s list of requests for paperwork reduction:

 

Some sample questions include:

  • Is the regulation still current, or is it outdated or unnecessary in some way?
  • Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
  • Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority?
  • If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
  • Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
  • Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.</bullet

If you are curious about President Trump’s executive order 13771, “Reducing Regulation and Controlling Regulatory Costs” the full text is here.