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Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information

FDA has released for public comment a notice on “Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information.” Based on current scientific evidence establishing the health risks associated with the consumption of trans fat, the FDA has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food, and therefore the PHOs are food additives.  If finalized, it would mean that food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.  The public is encouraged to review and submit comments and scientific data and information within 60 days of publication of the Federal Register notice (November 8, 2013) at http://www.regulations.gov.  The Federal Register notice is available at http://www.gpo.gov/fdsys/pkg/FR-2013-11-08/pdf/2013-26854.pdf.  FDA is seeking comments and additional scientific data and information related to this action and, in particular, request comment on the following: 

  1. Should FDA finalize its tentative determination that PHOs are no longer GRAS?
  2. Are there data to support other possible approaches to addressing the use of PHOs in food, such as by setting a specification for trans fat levels in food?
  3. How long would it take producers to reformulate food products to eliminate PHOs from the food supply? Are there likely to be differences in reformulation time for certain foods or for certain types of businesses?
  4. If FDA makes a final determination that PHOs are not GRAS and does not otherwise authorize their use in food, FDA intends to provide for a compliance date that would be adequate for producers to reformulate any products as necessary and that would minimize market disruption. FDA welcomes comments on what would be an adequate time period for compliance.
  5. Are there any special considerations that could be made to reduce the burden on small businesses that would result from removal of PHOs from foods, such as additional time for reformulation? Would those considerations be consistent with a final determination that PHOs are not GRAS?
  6. Are there other challenges regarding the removal of PHOs from foods? Are there products that may not be able to be reformulated? If so, what sorts of products and what challenges are faced?
  7. Is there any knowledge of an applicable prior sanction for the use of PHOs in food?

FDA Issues 2 New FSMA Proposed Rules
FDA has issued two new proposed rules under the Food Safety Modernization Act (FSMA) aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. Comments are due November 26, 2013.

Implementing the Food Safety Modernization Act: Proposed Rules for Produce and Preventive Controls for Human Food
FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act.  The public is encouraged to review and submit comments to the proposed rules. The proposed rules will be published in the Federal Register. FDA will review comments on the proposed rule and consider revising the rule, before issuing a final rule. Comments are due within 120 days of the rules’ publication in the Federal Register.

FDA releases preliminary findings on genetically engineered Atlantic Salmon
On December 26, 2012, FDA released the agency’s draft environmental assessment and preliminary findings on genetically engineered Atlantic Salmon (AquAdvantage).  FDA assessed the environmental impact of AquAdvantage Salmon as New Animal Drug Application (NADA) and made a preliminary determination that under the specific conditions proposed in the application, AquAdvantage Salmon would not have a significant effect on the quality of the human environment in the United States.  The FDA concluded that food from AquAdvantage Salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from AquAdvantage Salmon. Further, FDA did not identify significant food safety hazards or risks associated with AquAdvantage Salmon.  The draft environmental assessment and preliminary findings are available for public comments.  Comments can be submitted to the agency by February 25,2013.

GAO releases new report "FDA's Food Advisory and Recall Process Needs Strengthenin"
GAO recommends, among other things, that FDA issue regulations or industry guidance to clarify its ordered food recall process and implement recommendations from others to address FDA communication challenges in advising the public about food recalls and outbreaks. The agency neither agreed nor disagreed with GAO’s recommendations but cited ongoing agency actions that are to address most recommendations.  Four recommendations aim to strengthen FDA’s process for ordering recalls and 3 recommendations address FDA’s communication challenges in advising the public about
food recalls and outbreaks.

Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives
This guidance is intended to recommend that you consult with the FDA regarding a significant change in manufacturing process for a food substance already in the market, irrespective of your conclusion about whether that change affects the safety or regulatory status of the food substance.  Any manufacturing change has the potential to be significant, and this remains true for changes or novel products, involving nanotechnology. Alterations in particle size distribution on the nanometer scale,3 which alter the physical and/or chemical properties of food ingredients and FCSs, can sometimes be significant manufacturing changes. The discussion in this document of nanotechnology, --in particular, intentional alterations of particle size distribution on the nanometer scale -- primarily addresses circumstances in which there has been a manufacturing change to a food substance already used in food.

FDA releases new Global Engagement Report
The report describes the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically. The report outlines a variety of engagement strategies the FDA is using in partnership with other agencies, organizations and coalitions around the world to strengthen global, regulatory capacity-building efforts; develop and harmonize science-based regulatory standards; increase awareness about the importance of regulatory systems; and share information and data globally to facilitate rapid identification of and response to public health emergencies.

FSMA Rulemakings: New IFT Webcast Series to Launch 
Beginning in February and in collaboration with the FDA, IFT will be hosting a series of live webcasts focused on the soon-to-be-released Food Safety Modernization Act (FSMA) rulemakings. This webcast series, featuring both FDA and other expert speakers, will provide participants with insight into details of the new rulemakings, as well as the opportunity to pose questions to FDA and receive additional clarification from experts on how these rule makings impact the food industry and your work. These webcasts will be available to IFT members free of charge. Non-members may participate for a fee of $49 per webcast. Please watch for additional details on ift.org.

The Food Safety Law and the Rulemaking Process: Putting FSMA to Work
Text: The new food safety law calls for a number of rules (also called regulations) and guidances. This will not happen overnight and will not happen in a vacuum.  Under the new food safety law, FDA will be issuing a number of rules including a preventive controls rule in food facilities, a foreign supplier verification rule, and a produce safety rule.  Every rule is developed under slightly different circumstances.  This is an overview of the process FDA follows when it issues rules under "notice and comment rulemaking."

FDA Sets Action Plan for Retail Food Safety Initiative
Body: the U.S. Food and Drug Administration (FDA) announced Sept. 29th, a Retail Food Safety Action Plan that includes several measures to help assure the safety of food sold in food stores, restaurants, schools, and other foodservice operations in the United States.  The Action Plan focuses on improving the way managers of these establishments conduct food safety operations in their facilities, as well as improving the oversight of these establishments by public health agencies at the Federal, state and local levels.

USDA Takes New Steps to Fight E. Coli, Protect the Food Supply
WASHINGTON, Sept. 13, 2011 – The U.S. Department of Agriculture announced today that it is taking new steps to fight E. coli and protect the safety of the American food supply. Six additional serogroups of pathogenic E. coli will be declared adulterants in non-intact raw beef. Raw ground beef, its components, and tenderized steaks found to contain these bacteria will be prohibited from sale to consumers. USDA's Food Safety and Inspection Service (FSIS) will launch a testing program to detect these dangerous pathogens and prevent them from reaching consumers.

FDA unveils new global strategy to help ensure safety and quality of imported products

The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality."

The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change:
1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
3.  The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

National Organic Program (NOP) requests comments on substances scheduled for sunset review by the National Organic Standards Board (NOSB)
The NOP requests input on whether several substances on the “National List” that are exempted (allowed) synthetic substances or nonsynthetic substances prohibited in organic crop and livestock production should be renewed. The National Organic Standards Board (NOSB) Crops Committee will review listings for substances including copper sulfate, ozone gas, peracetic acid, and calcium chloride. The NOSB Handling Committee will review listings for substances including agar-agar, animal enzymes, calcium sulfate, carrageenan, glucono delta-lactone, tartaric acid, and cellulose. The allowed uses or prohibitions will expire on Nov. 3, 2013 and the substances will be removed from the National List if their exemptions or prohibitions are not continued.  The deadline for submission of comments in response to the Advance Notice of Proposed Rulemaking is Aug. 1, 2011.


Department of Commerce's International Trade Administration seeks comments on regulatory cooperation between the United States and European Union

The ITA seeks input on opportunities for cooperation to reduce or eliminate divergent regulatory measures that impede trade in goods in the transatlantic marketplace.  The largest trading partner of the United States, the EU has been identified by the ITA as a mature market for which ways are sought to reduce unnecessary differences in regulation and standards negatively impacting trade for U.S. firms.  The ITA identified specific possible types of regulatory cooperation (e.g., mutual recognition agreements) for which it invites comments.  The Administration also seeks recommendations for specific current or emerging product sectors that may benefit from regulatory cooperation between the EU and US.  Interested parties are encouraged to submit comments jointly.

Joint FAO/WHO Call for Data and Experts on Foodborne Parasitic Diseases
Within the joint activities on risk assessment of microbiological hazards in foods, the United Nations’ Food and Agriculture Organization and World Health Organization have issued an international call for data and information on foodborne parasitic diseases, particularly that which may not be readily publically available. Data and information is sought on the impact of foodborne parasitic disease, monitoring and inspection, control and management of food contamination and disease prevention, risk assessment/profiles, and risk ranking.  Data on these areas are sought from governments, interested organizations, health care providers, academia, veterinarians, the food industry, consumer groups, laboratories, and individuals. FAO and WHO also are also identifying experts to participate in future work in this area. The deadline for submission of information and expert applications is July 31. 2011.

Experimental Study on Consumer Responses to Labeling Statements on Food Packages
The Food and Drug Administration (FDA) has published a Federal Register notice requesting public comments on a proposed study entitled "Experimental Study on Consumer Responses to Labeling Statements on Food Packages."  76 Fed. Reg. 20675 (April 13, 2011).  Comments are due by June 13, 2011.

Implementation of the Food Safety Modernization Act (FSMA) provision on hazard analysis and preventive controls
The Food and Drug Administration (FDA) has published a Federal Register notice announcing a public meeting on implementation of the Food Safety Modernization Act (FSMA) provision on hazard analysis and preventive controls.  76 Fed. Reg. (April 13, 2011).  The all-day meeting will be held at FDA's White Oak campus on April 20, 2011.  FDA is also requesting comments, which must be submitted by May 20, 2011.

The Food and Drug Administration (FDA) has published proposed rules to require nutrition labeling of foods sold in chain restaurants and by chain vending machine operators:

  • Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.  76 Fed. Reg. 19192 (April 6, 2011
  • Food Labeling: Calorie Labeling of Articles of Food in Vending Machines.  76 Fed. Reg. 19238 (April 6, 2011)

Comments on the menu labeling proposed rule are due June 6, 2011.  Comments on the vending machine labeling proposed rule are due July 5, 2011.  For both proposed rules, comments on information collection issues must be submitted to the Office of Management and Budget (OMB) by May 6, 2011. 

FDA seeks comments on a proposed new study to explore consumer responses to food labels bearing multiple labeling statements.
The study will help the Agency understand how multiple claims and other labeling statements on food packages may affect consumer perceptions of products and labels, and resultant dietary choices. Comments are sought on aspects of the burden and necessity of the information collection, and ways to enhance the quality, utility, and clarity of the information to be collected. Comments are due by June 13, 2011.

The Food and Drug Administration (FDA) held two public meetings the week of March 28th on implementation of the import provisions of the FDA Food Safety Modernization Act (FSMA) (PDF Download)

Federal Food Safety Oversight: Food Safety Working Group Is a Positive First Step but Governmentwide Planning Is Needed to Address Fragmentation
For more than a decade, GAO has reported on the fragmented nature of federal food safety oversight and how it results in inconsistent oversight, ineffective coordination, and inefficient use of resources. This review examines: (1) steps, if any, that the FSWG has taken to increase collaboration among federal food safety agencies, and (2) options we and others have identified to reduce fragmentation, overlap, and potential duplication in food safety oversight. GAO reviewed information about the FSWG and alternative organizational structures for food safety, and conducted interviews.

Food Defense Mitigation Strategies Database
The US Food and Drug Administration (FDA) recently announced a new database for utilization by the food industry to help protect the nation's food supply from deliberate acts of contamination or tampering. The Food Defense Mitigation Strategies Database (MSD) was developed by FDA as a resource for companies that produce, process, store, package, distribute, and/or transport food or food ingredients.

The Food Safety Modernization Act: What Does it Mean for Importers (PDF Download)
The legislation raises the bar for entry of product into the country with additional minimum requirements and the ability to require certifications for certain types of imported food. New importer verification requirements place the accountability for the safety of food on importers.

FDA Reopens Comment Period for 1997 GRAS Notification Proposed Rule (PDF Download)
After cooling its heels for over ten years, the Food and Drug Administration ("FDA" or "Agency") finally appears to be making some progress moving the proposed voluntary GRAS Notification regulation forward. The voluntary Notification procedure was originally proposed in the Federal Register in 19971 and was intended to replace the voluntary regulatory petition process at 21 C.F.R. 170.35 to affirm the generally recognized as safe ("GRAS") status of a substance intended for use in food for humans or animals. The deadline to submit comments is March 28, 2011.

Food Safety Legislation Passed Congress- Now What? (PDF Download)
After a memorable trip through Congress, the Food Safety Modernization Act is on President Obama's desk awaiting the final signature. Once signed, several key provisions of the bill will immediately go into effect, including:

  • Expanded records access
  • Increased inspection frequencies
  • Mandatory recall authority
  • Authority to require import certifications for food

Summary of the FDA Food Safety Modernization Act and its potential impact on the food industry (PDF Download)
The FDA Food Safety Modernization Act represents the most significant expansion of food safety requirements and FDA food safety authorities since the original enactment of the FD&C Act in 1938. It grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. Therefore, implementation of the legislation is likely to take several years. This memorandum summarizes the FDA Food Safety Modernization Act (FSMA) and its potential impact on the food industry.

Funding for Child Nutrition Programs
The U.S. House of Representatives passed a $4.5 billion child nutrition bill on a 264-157 vote Thursday, sending the bill on to President Barack Obama.

GAO Report on Live Animal Imports
The U.S. Government Accountability Office recommended to the Committee on Homeland Security & Government Affairs, U.S. Senate in this GAO-11-9 report that the Secretaries of Agriculture, Health and Human Services, Homeland Security, and the Interior develop a strategy to address barriers to agency collaboration that may allow potentially risky imported animals into the United States and jointly determine data needs to effectively oversee imported animals.

CRS Report for Congress: Nanotechnology and Environmental, Health, and Safety: Issues for Consideration (PDF Download)
The Congressional Research Service issued this report by John F. Sargent, Jr. on Sept. 29. The report addresses the potential environmental, health, and safety opportunities and challenges of nanotechnology; environmental health and safety concerns; and options for congressional action, including the nanotechnology environmental health and safety-related provisions of selected legislation.

EPA Issues Significant New Use Rules on Two Carbon Nanotube Substances
The Environmental Protection Agency issued on Sept. 17 the final rule: "Multi-Walled Carbon Nanotubes and Single-Walled Carbon Nanotubes; Significant New Use Rules," under section 5(a)(2) of the Toxic Substances Control Act. The action requires those who intend to manufacture, import, or process either of these two chemical substances for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before beginning the activity.

GAO Report on Nanotechnology (PDF Download)
The United States Government Accountability Office provided on May 25 the Chairman, Committee on Environment and Public Works, U.S. Senate, the report entitled "Nanotechnology: Nanomaterials are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk."

GAO Report (PDF Download)
The U.S. Government Accountability Office (GAO) recently published two reports containing recommendations for improvement of food regulatory activities by the Food and Drug Administration (FDA).

IOM Report on FDA Role in Enhancing Food Safety (PDF download)
The Institute of Medicine (IOM) and the National Research Council (NRC) yesterday released a consensus report, entitled Enhancing Food Safety: The Role of the Food and Drug Administration. The report was requested by Congress and sponsored by the Food and Drug Administration (FDA). The IOM committee responsible for the report included representatives from academia, state government, and industry.

Child Nutrition Reauthorization S3307
The Healthy, Hungry-Free Kids Act of 2010, an original bill to reauthorize child nutrition programs.

Obesity Legislation
The "Healthy Choices Act" [H.R 5209] has been introduced in the US House of Representatives by Rep. Kind (D-Wis) – The bill has the support of the Grocery Manufacturers Association, the American Heart Association and others - The intent of the bill is to "... align federal food programs with existing governmental nutritional guidelines; make healthy foods affordable and accessible to children and adults most at risk, including rural and low-income urban areas; coordinate the federal response to addressing the obesity crisis (including realigning transportation policy to encourage healthier lifestyles); and provide children and adults with opportunities for physical activity, nutritional information and assessment tools..."

The Healthy Choices Act (PDF Download)

America Competes Act (PDF Download)
Enacted in 2007, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (P.L. 110-69) is being considered for reauthorization this year. The law responded to concerns about long-term U.S. economic competitiveness and innovative capacity by authorizing increased investments in science, technology, engineering, and mathematics (STEM) education and federal research in the physical sciences and engineering. Statutory authorities for certain America COMPETES Act provisions expire in 2010. Two America COMPETES Act reauthorization bills have been introduced in the House: H.R. 5116 and H.R. 5325. Both measures are titled the "America COMPETES Reauthorization Act of 2010

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010, HR 2997

FDA Issues Draft Revised Guidance For Reportable Food Registry (PDF Download)
The Food and Drug Administration (FDA) has issued a draft revised guidance document on the Reportable Food Registry. FDA, Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007

FDA Transparency Task Force Unveils Draft Proposals (PDF Download)
On May 19, 2010, FDA's Transparency Task Force released 21 draft proposals for public comment on public disclosure policies aimed at helping consumers, stakeholders, and others understand how the agency operates and makes decisions. The proposals are part of the second phase of the FDA's Transparency Initiative launched last summer by FDA Commissioner Margaret Hamburg and reflect the review of more than 1,500 public comments received by the FDA after two public meetings held by the task force and extensive consideration and discussion within the agency.

Nanotechnology Safety Act of 2010
Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to establish within the Food and Drug Administration (FDA) a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products.

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