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Industry News and Press: Regulatory Updates

September & October 2017 Regulatory Update

Tuesday, September 26, 2017   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from September 1 through October 30, 2017. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

September-October 2017 Regulatory Update includes Proposed Extended Compliance Date for Nutritional, Supplement and Serving Size Labeling; Food Safety Modernization Act (FSMA) Updates; Developments of Interest



On September 29, 2017, the FDA released a proposed rule to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. As proposed by FDA, manufacturers with less than $10 million in annual food sales would receive one extra year to comply, until January 1, 2021. The proposed rule, "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 Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Proposed Extension of Compliance Dates,” may be found below. >>Read more



FDA Announces New Steps to Collaborate with States and Ensure Farmers are FSMA Prepared  
On September 12, 2017, FDA Commissioner Scott Gottlieb, M.D., announced immediate next steps in FDA’s approach to ensuring successful implementation of the Produce Safety Rule established by FSMA. The next steps include 1) the proposed rule, described below, to extend the compliance dates for agricultural water requirements for produce other than sprouts for an additional two to four years; 2) FDA engaging with stakeholders to learn more about the ways water is used and ensure the standards will be as practical and effective as possible; 3) FDA addressing potential additional other methods of agricultural water testing (FDA has posted the list of methods it has determined to be equivalent to the method in the Produce Safety Rule, including eight additional testing methods from the U.S. Environmental Protection Agency and other public health entities); 4) inspections to begin in 2019 to assess compliance with the non-water requirements of the Produce Safety Rule that large farming operations must still meet by January 26, 2018; and 4) FDA ensuring that produce farmers and state regulators have the training needed to implement the Produce Safety Rule, with training of state regulators to be a top priority for FDA in 2018.  >>Read more  

FDA Issues Proposed Rule that, if Finalized, Would Extend Compliance Dates for Certain Agricultural Water Requirements for Produce Other Than Sprouts 
On September 13, 2017, FDA issued a proposed rule, "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E,” that, if finalized, would extend the compliance dates for agricultural water requirements under Subpart E of the FSMA for produce other than sprouts, based upon farm size. The new proposed compliance date for largest farms is January 26, 2022, and for small farms and very small farms, January 26, 2023 and January 26, 2024, respectively. As part of the proposed extension, FDA also proposes to simplify the compliance period structure for subpart E (Agricultural Water) so that all of the compliance dates for subpart E provisions applicable to non-sprout produce would occur at the same time, although retaining the staggered dates based upon farm size. Comments on the proposed rule are due by November 13, 2017.

In the preamble of the final rule establishing the produce safety regulation under FSMA, FDA stated that the produce safety regulation would be effective on January 26, 2016 and provided for compliance dates of one to six years from the effective date depending on farm size, commodity and provisions(s). For the majority of agricultural water provisions at subpart E, with respect to covered produce other than sprouts, compliance periods of four years from the effective date of the rule for very small businesses, three years for small businesses, and two years for all other businesses, were provided. An additional two years beyond those compliance periods were provided for certain water quality requirements in 21 CFR §112.44 and related provisions in §112.45 and §112.46.  In FDA’s final rule, "The Food and Drug Administration Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules,” 81 FR 57784, August 24, 2016, FDA extended the compliance date for certain "customer provisions” in the produce safety regulation and clarified the compliance dates for certain agricultural water testing provisions.
The new proposed extensions now arose out of comments received by FDA from numerous stakeholders as to the practicality of some of the agricultural water requirements in the product safety regulation for produce other than sprouts. FDA announced the proposed extension on the basis of this feedback as well as Executive Orders 13777, 13771, and 13563 (agency designation of Regulatory Reform Officer and reform initiatives, identification of at least two existing regulations to be repealed to promulgate a new regulation, and improving regulation and regulatory review, respectively).  

The proposed rule relates to compliance dates, but does not address the underlying requirements.  FDA announced in Part II of the Supplementary Information for the proposed rule that it intends to complete this rulemaking as quickly as possible. In the meantime, FDA "intends to exercise enforcement discretion for covered produce other than sprouts relative to the agricultural water provisions in subpart E of the produce safety regulation.”  82 FR 42963.  FDA explained that what this means is that "while we are considering these issues, we do not intend to enforce the requirements in Subpart E of the regulation for covered produce other than sprouts.” 82 FR 42963. Additionally, during this additional time, FDA will "consider approaches to address these issues, as well as opportunities there may be to reduce the cost and enhance the flexibility of these requirements beyond those reflected in the final rule.”  82 FR 42963.  >>Read more 

FDA Issues Small Entity Compliance Guide for Growing, Harvesting, Packing and Holding of Produce         
As reported previously, in September 2017, FDA issued a Small Entity Compliance Guide entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide.”  >>Read more 


Comment Period Remains Open Until December 7, 2017 on FDA Request for Comments and Information from Interested Parties to Help FDA Identify Regulations that could be Modified, Repealed or Replaced pursuant to Executive Order 

On January 30, 2017, the White House announced an Executive Order for Reducing Regulation and Controlling Regulatory Costs (Executive Order 13771).  Executive Order 13771 directs regulatory agencies to eliminate two existing regulations for every new regulation to be adopted.  FDA has published in the Federal Register a request for comments and information from interested parties to help FDA identify regulations that could be modified, repealed or replaced pursuant to this Executive Order, consistent with the law, in order to balance regulatory burden with its public health mission and statutory obligations. This request related to products regulated by the Center for Food Safety and Applied Nutrition (CFSAN).   Electronic or written comments are to be submitted by December 7, 2017.  >>Read more 

Public Comment Period Remains Open Until December 4, 2017 for FDA Public Meeting Held October 3rd Regarding Dietary Ingredients

As reported in our last Update, FDA was to and has now held a public meeting on October 3, 2017, Development of a List of Dietary Ingredients that Pre-Date the Dietary Supplement Health and Education Act of 1994 (DSHEA), to discuss the development of a list of pre-DSHEA dietary ingredients.  Topics for the meeting included what evidence is necessary to show an ingredient was marketed prior to October 15, 1994 and what process should be used to develop the list. The public comment period extends until December 4, 2017.  See the link below for more information, including how to comment.  >>Read more 

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