Tag Archives: PROPOSED RULE

FDA Issues Proposed Rule to Implement a Laboratory Accreditation Program for Food Testing as Required by FSMA

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The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet. On November 1, 2019, FDA released a proposed rule under which FDA … Continue Reading

FDA Proposes New Graphic Warnings for Cigarettes

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The Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by Section 201 of the Family Smoking Prevention and Tobacco Control Act (TCA; signed into law on June 22, 2009) directs the U.S. Food and Drug Administration (FDA) to develop graphic warnings for cigarette packages and promulgate regulations requiring the warnings within 24 months of … Continue Reading

California Proposes Amendments to Proposition 65 Regulation on the Responsibility to Provide Consumer Product Warnings

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In response to confusion regarding Section 25600.2 of the new Article 6 warning regulations, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify how a product manufacturer—and other parties that may receive the products before the retailer—can pass warning information (and the responsibility to warn) along the supply chain and ultimately … Continue Reading

USDA Extends Comment Period for Proposed Rule to “Modernize” Pork Inspection

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On January 19, 2018, USDA released a proposed rule called the “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in pork slaughter.  … Continue Reading

USDA Releases Proposed Rule to “Modernize” Pork Inspection

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Last week, we reported that the White House Office of Management and Budget (OMB) cleared USDA’s “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in … Continue Reading

USDA Announces Proposed Rule to Amend Egg Products Inspection Regulations

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The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products to develop Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the … Continue Reading

Taiwan to Strengthen Allergen Labeling for Prepackaged Foods

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On December 11, 2017, the Food and Drug Administration of Taiwan (TFDA) released an announcement intending to repeal the existing food allergen labeling regulations and replace it by a new regulation, which was published at the same time for comments. Under the proposed new regulation, TFDA consolidates the existing six categories of foods that are … Continue Reading

USDA Withdraws Biotech Regulation Proposal

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As previously covered on this blog, on January 19, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS)published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in response to advances in genetic engineering and the Agency’s understanding of the plant … Continue Reading

FDA Releases Proposed Rule Seeking to Revoke Health Claim that Soy Protein Reduces Risk of Heart Disease

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Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements … Continue Reading

FDA Publishes Proposed Rule Seeking to Extend Compliance Dates for Agricultural Water Standards

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FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water … Continue Reading

Update: Industry Urges USDA to Start Over on Proposed Rule to Revamp APHIS Biotech Regs

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For decades, the U.S. government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs: The Food and Drug Administration (FDA) regulates GMOs under the … Continue Reading

USDA Publishes Proposed Rule to Revamp Its Biotechnology Regulations

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For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs: The Food and Drug Administration (FDA) regulates GMOs under … Continue Reading

Beep Beep, BPA

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California proposes to amend Prop 65 warning requirements for BPA in canned and bottled foods and beverages. In May 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) added bisphenol A (BPA) to the Prop 65 list as a reproductive toxicant.   On April 18, 2016, OEHHA implemented an emergency regulation for BPA, providing a safe harbor warning strategy to … Continue Reading

Import(er) Alert: E-Filing Proposed Rule

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FDA proposes e-filing requirements to facilitate product imports. FDA and the U.S. Customs and Border Protection Agency (CBP) work together to facilitate the admission of imported products into the U.S.  The Automated Commercial Environment (ACE) is a commercial trade processing system operated by CBP that helps automate and expedite the processing of imports and exports. Earlier … Continue Reading

Pork Parasite Proposal

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FSIS proposes to eliminate trichinae control requirements it deems unnecessary. Trichinella is a parasitic worm that can infect humans and other animals.  Although relatively few cases of human infection are reported each year, swine are known to be the primary source of such infections.  In 2001, the U.S. Department of Agriculture’s (USDA) Food Safety and … Continue Reading

Gluten-Free Go-Round

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FDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods. As previously covered on this blog, FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting … Continue Reading

Sounds Fishy: New Seafood Traceability Program

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NOAA proposes new traceability program for certain types of seafood. For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  Data from one of the largest seafood fraud investigations in the world indicate that snapper and tuna were mislabeled most frequently, … Continue Reading

Grounds for ‘Gluten-Free’

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FDA Proposes Rule on ‘Gluten-Free’ Requirements for Fermented, Hydrolyzed and Distilled Foods In August 2013, FDA issued a final rule on voluntary “gluten-free” food labeling.  The final rule defined “gluten-free” as meaning that the food either is inherently gluten free or does not contain an ingredient that is: a gluten-containing grain (e.g., spelt wheat); derived … Continue Reading

“Local” News

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“Local” claims could become latest trend in food labeling. For years, food marketers have relied on claims such as “organic” and “natural” to attract consumers in the marketplace.  “Non-GMO” claims also have become more popular of late.  The U.S. Department of Agriculture (USDA) administers the regulatory regime governing “organic” claims, but no consistent or clear … Continue Reading

Sugar Addendum

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FDA proposes adding the percent daily value for added sugars to the nutrition/supplement facts panel. In March 2014, FDA proposed major revisions to the nutrition and supplement facts labels for foods and dietary supplements.  Among many other changes, FDA proposed requiring the declaration of “added sugars” on the label. On July 27, 2015, FDA issued … Continue Reading

Accreditation Activity

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FDA issues a proposed rule and draft guidance to implement its third-party accreditation program under FSMA. The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for accrediting third parties to conduct food safety audits and issue certifications for facilities and food.  The Agency may use certifications:  (1) as a condition of … Continue Reading

Antibiotic Ask

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FDA proposes to expand collection of data on animal drug usage to include major food-producing species. For years, FDA and the animal feed industry have grappled with how to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In 2013, FDA asked animal pharmaceutical companies to voluntarily … Continue Reading

FSMA Update: Farm-Direct Sale Exemption

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FDA proposes to exempt farms that sell directly to consumers from registration requirement. Many requirements of the FDA Food Safety Modernization Act (FSMA) are linked to FDA’s facility registration requirement.  For instance, FDA registration is the key trigger for compliance with FSMA’s hazard analysis and risk-based preventive control (HARPC) requirements. FDA has issued a proposed … Continue Reading

Backing Up on Biotech

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APHIS withdraws 2008 proposed rule related to the regulation of GM crops. USDA’s Animal and Plant Health Inspection Service (APHIS) evaluates genetically modified (GM) crops as potential plant pests under the authority of the Plant Pest Act.  On October 9, 2008, APHIS issued a proposed rule that would have expanded its authority to regulate GM … Continue Reading
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