Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 6
FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule
On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions (subpart E) in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule ("Produce Safety Rule"). The Produce Safety Rule is one of the seven final rules that have been issued as part of the implementation of the FDA Food Safety Modernization Act ("FSMA"). Issued on November 27, 2015, this rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms, with the exception of produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity.
The new compliance dates—if the rule is finalized—are January 26, 2024, for very small businesses, January 26, 2023, for small businesses, and January 26, 2022, for all other businesses. The proposed dates do not apply to sprouts because of their "unique safety risk," as explained in the proposed rule. With the exception of small and very small businesses, businesses conducting activities involving sprouts have had to comply with the Produce Safety Rule since January 2017. FDA has decided to extend the compliance dates for the water provisions to address questions about their practical implementation—farmers and state agriculture officials have indicated that the microbial quality standards for agricultural water are too complicated, and in some cases too costly—and to consider how to reduce the regulatory burden or increase flexibility. In addition, as explained by FDA Commissioner Dr. Gottlieb, FDA will continue its "focus on training, guidance development, and outreach over the next year." FDA has awarded more than $30 million to support 43 states in their development of produce safety programs, which builds on the nearly $22 million that the FDA awarded last year to 42 states. FDA is accepting comments on the proposed rule until November 13, 2017.
USDA Publishes Study of Electronic or Digital Bioengineering Disclosure
As mandated by the 2016 National Bioengineering Food Disclosure Standard Act, the Agricultural Marketing Service ("AMS") of USDA recently released a study titled "Study of Electronic or Digital Disclosure." The Act, which requires AMS to establish by July 29, 2018, a national mandatory bioengineered food disclosure standard for how food for human consumption will be disclosed as containing bioengineered ingredients, also required AMS to conduct a study to "identify potential technology challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure methods." AMS sought comments to design the study on September 1, 2016, and requested a vendor to conduct it and submit it to the agency by May 30, 2017, for publication by AMS on July 29, 2017. Although a few days late (and facing a complaint filed by the environmental advocacy organization Center for Food Safety for not meeting the deadline), AMS released the study on September 6, 2017.
As required by the Act, the study considers five factors: (i) the availability of wireless internet or cellular networks; (ii) the availability of landline telephones in stores; (iii) challenges facing small and rural retailers; (iv) the efforts that retailers and other entities have taken to address potential technology and infrastructure challenges; and (v) the costs and benefits of installing in retail stores electronic or digital link scanners or other evolving technology that provide bioengineering disclosure information. The results of the study show that the majority of Americans own a smartphone (77 percent), and ownership rates are trending upward; most Americans live in areas with sufficient broadband access (93.6 percent) to scan a digital link; all national chain stores and most regional chain stores (97 percent) provide Wi-Fi in store; and 37 percent of small retailers already provide Wi-Fi to consumers in store. However, consumers may recognize digital links but lack familiarity with scanning, and many consumers (85 percent) experienced technical challenges using certain mobile software applications for scanning digital links. In addition, scanning digital links requires access to the internet; therefore, some retailers may need to install Wi-Fi networks for consumers without access to cellular data or local Wi-Fi networks.
In furtherance of drafting a proposed rule to establish a national mandatory bioengineered food disclosure standard, in June 2017, AMS requested public comments on 30 questions. The questions related to different matters, including what factors or conditions AMS should consider for a food to be considered a bioengineered food, how "small food manufacturers" or "similar retail food establishments" should be defined for purposes of excluding them from the requirements of the regulation, and what the appropriate procedures should be for audits and other compliance actions, including opportunities for hearing, for AMS to consider prior to conducting an examination of noncompliance. Questions related to electronic or digital disclosure were also on the list. For instance, AMS requested comments on what electronic or digital disclosure (or text or symbol) AMS should require (including for bioengineered food sold in bulk, vending machines, or online), and how AMS should ensure that an electronic or digital disclosure can be easily and effectively scanned or read by a device. The deadline to comment on these questions was August 25, 2017. Interested parties also will be able to comment on the proposed rule when published.
Dispute Over the Labeling of Plant-Based "Milk" Products
A lawsuit against a plant-based product manufacturer raised the issue of whether plant-based products, such as those labeled as soymilk or almond milk, have to be labeled as "imitation" products when food contains less protein or essential vitamins or minerals than the original product (21 C.F.R. § 101.3(e)). The complaint alleged that plant-based "milk" products mislead the consumer as they are not milk as defined by FDA ("the lacteal secretions […] obtained by the complete milking of one or more healthy cows") and are nutritionally inferior to cow milk products. A California court decided to stay and defer the case to the FDA.
Previous decisions from other courts in California have rejected that argument. For instance, one court held that it is "patently implausible" the consumer would be misled by "almond milk" as the products bear an appropriate qualifier—"almond." That court noted that "if the consumer is concerned about the nutritious qualities of the product, they can read the nutrition label." [add appropriate link: Cynthia v. Blue Diamond Growers (document in PDF)].
It is not clear whether FDA will decide on this issue in the near future. A citizen petition was submitted by the Good Food Institute in March 2017, and FDA responded it could not respond to the petition within the mandated 180 days of its receipt because of "other agency competing priorities." FDA did not provide a certain date by which it would respond to the petition, which requested FDA to issue regulations clarifying how foods may be named by reference to the names of other "traditional" foods in a manner that makes clear to consumers their distinct origins or properties. FDA provided a similar response to Soyfoods Association of America, which submitted a citizen petition in 1997 requesting FDA to recognize "soymilk" as the established common or usual name to be used on labels and other labeling to identify beverages of this nature.
FDA Launches Food Safety Plan Software to Assist with FSMA Compliance
Last month, FDA launched the Food Safety Plan Builder ("FSPB"), a free software application developed by FDA to help food businesses meet the requirements of the FSMA Final Rule for Preventive Controls for Human Food. Accompanied by a series of YouTube videos and an 84-pages guide, the software program, through a series of questions that help identify potential hazards and preventive controls, assists owners and operators develop customized food safety plans to their facilities. The use of the FSPB is voluntary and "does not imply FDA approval of the resultant food safety plan." FDA modeled FSPB after the Food Defense Plan Builder, which was created to assist food facilities with developing personalized food defense plans for their facilities.
EU Proposes a More Modern and Harmonized Organic Production and Labeling Regulation
On June 28, 2017, the Council and the European Parliament reached a preliminary agreement on the amendment of EU Regulation (EC) No 834/2007 on organic production and labeling. The proposal is intended to improve the legislation on organic production in order to: (i) remove obstacles to the sustainable development of organic production in the European Union; (ii) guarantee fair competition for farmers and operators and allow the internal market to function more efficiently; and (iii) maintain or improve consumer confidence in organic products by strengthening the control system via stricter checks in the supply chain. Among other changes, the new rules would extend the scope of the existing organic rules to cover a wider list of products (e.g., salt, cork, beeswax, maté, vine leaves, palm hearts) and additional production rules (e.g., for deer, rabbits, and poultry), support small farmers by introducing a new system of group certification, and provide a more uniform approach on pesticides.
The proposal will be submitted to the European Parliament for a vote at first reading and to the Council for final adoption. If approved, the new regulation would be applicable to industry by July 1, 2020.
FDA Requests Comments on Existing Regulation
In the September 8, 2017, Federal Register, FDA sought comments and information from interested parties to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced. FDA is particularly interested in receiving comments and information on: (i) whether the regulation is still current or is outdated or unnecessary; (ii) whether regulated entities have had difficulties complying with the regulation; (iii) whether the regulation imposes requirements that are also provided for in voluntary or consensus standards or guidance by third-party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius); (iv) whether the regulation contains redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, recordkeeping, or labeling requirements; (v) whether the goal of the regulation could be achieved by less-costly means that would provide the same level of public health protection; and (vi) what factors FDA should consider in selecting and prioritizing regulations and reporting requirements for reform. This request is part of the implementation of Executive Order 13771 titled "Reducing Regulation and Controlling Regulatory Costs," and Executive Order 13777 titled "Enforcing the Regulatory Reform Agenda." Comments are due December 7, 2017.
FDA Issues Guidance on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
In the September 6, 2017, Federal Register, FDA announced the availability of a guidance for industry titled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide." The small entity compliance guide is intended to help small entities comply with one of the FSMA's final rules titled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption," which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The final rule became effective January 26, 2016, but has staggered compliance dates starting January 26, 2017.
FDA Issues Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
In the August 31, 2017, Federal Register, FDA announced the availability of another draft chapter of a multichapter guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry." This multichapter draft guidance is intended to explain FDA's current thinking on how to comply with FSMA's requirements for hazard analysis and risk-based preventive controls under the rule "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is titled "Chapter Six—Use of Heat Treatments as a Process Control."
FDA Issues Guidance on Mitigation Strategies to Protect Food Against Intentional Adulteration
In the August 25, 2017, Federal Register, FDA announced the availability of a guidance for industry titled "Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need To Know About the FDA Regulation: Small Entity Compliance Guide." This guide is intended to help small entities comply with one of FSMA's final rules entitled "Mitigation Strategies to Protect Food Against Intentional Adulteration," which requires domestic and foreign food facilities to address hazards that may be introduced with the intention to cause widescale public health harm.
FDA Approves Food Additive for Feed and Drinking Water of Animals
In the August 15, 2017, Federal Register, FDA issued a final rule amending the regulations for food additives to provide for the safe use of oil from a variety of bioengineered safflower in complete dry adult maintenance dog food. The safflower variety has been bioengineered to contain a gene from the water mold Saprolegnia diclina responsible for production of gamma-linolenic acid ("GLA") in the seed oil. This GLA-enriched safflower oil will be used as a source of omega-6 fatty acids in dry food for adult dogs. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc., which in the September 14, 2017, Federal Register, petitioned the FDA also to amend the food additive regulations to provide for the safe use of GLA safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.
FDA Issues Guidance Related to Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products
In the August 14, 2017, Federal Register, FDA announced the availability of a guidance for industry titled "Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry." Ultrafiltered milk is milk that is mechanically filtered to concentrate large compounds, like proteins. In the process, smaller compounds, like lactose, are removed, along with water and mineral salts. The resulting protein concentrate is less expensive to ship than milk. The guidance advises manufacturers that wish to use ultrafiltered milk ("UF milk") or ultrafiltered nonfat milk ("UF nonfat milk") in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, FDA intends to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products and in the declaration of ingredients in the products' labeling.
FDA Announces Filing of Food Additive Petitions
In the July 26, 2017, Federal Register, here and here, FDA announced that a petition was submitted by the Juice Products Association proposing that the food additive regulations be amended to replace the current Recommended Daily Intake percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D3 with absolute values and to update the specifications for vitamin D3. Another petition was submitted by Zinpro Corp. proposing that the food additive regulations be amended to provide for the safe use of zinc-L-selenomethionine as a nutritional source of selenium in complete feed for laying hens and for the safe use of the approved food additive silicon dioxide as an anticaking agent for use with zinc-L-selenomethionine as a feed component. Both food additive petitions were filed on June 1, 2017.
FDA Amends Color Additive Regulations
In the July 3, 2017, Federal Register, FDA amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice. This action is in response to a color additive petition filed by McCormick & Company, Inc. This rule was effective August 3, 2017.
FSIS Approves Changes to Inspection Coverage in Official Establishments that Slaughter Fish of the Order Siluriformes
In the September 1, 2017, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") confirmed that it will adjust inspection coverage at official establishments that slaughter fish of the order Siluriformes from all hours of operation to once per production shift. This decision was based on the Agency's experience inspecting official fish slaughter establishments since implementing the mandatory inspection program on March 1, 2016, and finding that the typical fish slaughter operation is a streamlined, automated process that combines slaughter with processing in the same continuous operation. The rule was effective September 1, 2017. In addition, in the July 3, 2017, Federal Register, FSIS announced that starting August 2, 2017, all shipments of imported Siluriformes fish and fish products entering the United States must be presented at an official import inspection establishment for reinspection by FSIS personnel.
APHIS Proposes Rule on Procedures for Applying for Licenses and Renewals
In the August 24, 2017, Federal Register, USDA's Animal and Plant Health Inspection Service ("APHIS") solicited public comments on potential revisions to the licensing requirements under the Animal Welfare Act ("AWA") regulations. These revisions are intended to promote compliance with the Act, reduce licensing fees, and further prevent any individual whose license has been suspended or revoked, or who has a history of noncompliance, from obtaining a license or working with regulated animals. APHIS is interested in knowing: (i) whether it should establish a firm expiration date for licenses (such as three to five years) and if so, what the date should be and why; (ii) what fees would be reasonable to assess for licenses issued, and whether the existing license fees are reasonable, or whether they should be adjusted to take additional factors into consideration, such as the type of animals used in regulated activities; (iii) whether persons whose license has been suspended or revoked from buying, selling, transporting, exhibiting, or delivering for transportation animals during the period of suspension or revocation should also be prohibited from engaging in other activities involving animals regulated under the AWA, such as working for other AWA-regulated entities or using other individual names or business entities to apply for a license; and (iv) whether there are any other specific concerns or recommendations for reducing regulatory burdens involving the licensing process or otherwise improving the licensing requirements under the AWA. Comments are due October 23, 2017.
AMS Issues Final Rules on U.S. Standards for Grades of Shelled Walnuts and Walnuts in the Shell
In the August 22, 2017, Federal Register, USDA's Agricultural Marketing Service ("AMS") issued a final rule revising the U.S. Standards for Grades of Shelled Walnuts and the U.S. Standards for Grades of Walnuts in the Shell issued under the Agricultural Marketing Agreement Act of 1946. AMS amended the color requirements to include red-colored walnuts and removed the "Unclassified" section. The rule was effective September 21, 2017.
AMS Establishes Voluntary United States Standards for Grades of Frozen Onions
In the August 22, 2017, Federal Register, USDA's AMS announced new voluntary United States Standards for Grades of Frozen Onions. The grade standards provide a common language for trade, a means of measuring value in the marketing of frozen onions, and guidance on the effective use of frozen onions. This rule was effective September 21, 2017.
USDA Amends Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary under Various Statutes
In the August 9, 2017, Federal Register, the Agriculture Department amended the scope and applicability of USDA's uniform rules of practice governing adjudicatory proceedings to include actions initiated under subtitles B and D of the Agricultural Marketing Act of 1946, as amended. Subtitle B authorizes the Secretary to assess civil penalties (fines) against any packer or other person that violates Livestock Mandatory Reporting regulations, and Subtitle D authorizes the Secretary to take enforcement actions, including civil penalties (fines), against a retailer or any person engaged in the business of supplying a covered commodity to a retailer, that is determined not to have made good-faith effort to comply with Country of Origin Labeling regulations and has continued to willfully violate these regulations The rule was effective August 9, 2017.
AMS Amends National List within USDA's Organic Regulations
In the July 6, 2017, Federal Register, USDA's AMS issued a final rule amending the National List of Allowed and Prohibited Substances ("National List") within USDA's organic regulations, to prohibit the use of eight substances in organic production and handling after June 27, 2017. The prohibited substances are: Lignin sulfonate (for use as a floating agent); furosemide; magnesium carbonate; and the nonorganic forms of chia, dillweed oil, frozen galangal, frozen lemongrass, and chipotle chili peppers. The rule was effective August 7, 2017. This action also renewed three substances on the National List to continue to allow nonorganic forms of inulin-oligofructose enriched, Turkish bay leaves, and whey protein concentrate in organic products. This was applicable beginning June 27, 2017.
FCIC Finalizes Common Crop Insurance Policy Basic Provisions
In the June 27, 2017, Federal Register, USDA's Federal Crop Insurance Corporation ("FCIC") finalized the Common Crop Insurance Policy Basic Provisions and made amendments to the final rule, with request for comments, published in the Federal Register on June 22, 2016, that clarified and revised the policy definition of "practical to replant" and "replanted crop," and policy provisions regarding double cropping. The changes to the policy made in this rule are applicable for the 2018 and succeeding crop years for all crops with a contract change date on or after the effective date of the rule, and for the 2019 and succeeding crop years for all crops with a contract change date prior to the effective date of the rule. This rule was effective June 27, 2017.
EU Regulatory Updates
European Commission Publishes Notice and Q&A on Impacts of UK's Withdrawal from the EU in Relation to Biocides Sector
On September 13, 2017, the European Commission ("EC") published a "Notice to business operators in the field of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products." The notice provides guidance to companies operating in the biocides sector on the steps to be taken prior to Brexit. In particular, the EC notes that business operators should be mindful of ongoing and/or planned regulatory procedures involving the United Kingdom (e.g., active substance approval, renewal of an active substance approval, Union authorization, simplified authorization procedure, mutual recognition in parallel, renewal of product authorizations, etc.) when evaluating a Member State or reference Member State, including with regards to the expected timelines for such procedures in view of the United Kingdom's withdrawal from the EU on March 29, 2017, and the consequent cease of applicability of EU laws by March 30, 2019 (provided that the EU-UK withdrawal agreement does not establish another date or the period is extended by the European Council). In this respect, the EC advises that "where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, business operators should consider taking the relevant actions. For example, business operators may consider changing to another evaluating Member State."
The EC further reminds companies operating in the biocides sector that holders of product authorizations and active substance or product suppliers included on the list referred to in Article 95 of the Biocidal Products Regulation (EU) No 528/2012 must be established in the European Union (or, for active substance and product suppliers, have an EU representative). In order to provide further clarifications and practical guidance, the EC has also drafted a document in the form of "Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the Biocides sector," addressing the above-mentioned consequences. The EC intends to further update and complement the Q&A to reflect any changes or additional clarifications.
EFSA Adopts Conclusions on the Peer Review of the Pesticide Risk Assessment of Potential Endocrine-Disrupting Properties of Glyphosate
On September 7, 2017, the European Food Safety Authority ("EFSA") published its conclusions on the peer review of the pesticide risk assessment of the potential endocrine-disrupting properties of glyphosate. Glyphosate's representative uses are spraying applications against emerged annual, perennial, and biennial weeds in all crops (crops including but not restricted to root and tuber vegetables, bulb vegetables, stem vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf vegetables, and fresh herbs, legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar beets and fodder beets; orchard crops and vine, before planting fruit crops, ornamentals, trees, nursery plants, etc.) and foliar spraying for desiccation in cereals and oil seeds (pre-harvest). In accordance with a request by the EC, EFSA has conducted a peer review of the initial pesticide risk assessment of glyphosate carried out in 2015 by the rapporteur Member State, Germany, with the aim of considering the potential endocrine activity of the pesticide glyphosate. EFSA concludes that: "the weight of evidence indicates that glyphosate does not have endocrine disrupting properties through oestrogen, androgen, thyroid or steroidogenesis mode of action based on a comprehensive database available in the toxicology area. The available ecotox studies did not contradict this conclusion." In its conclusions, EFSA notes that no outstanding issues remain on this topic and that no critical areas of concern were identified in the context of the peer review.
ECHA Launches Public Consultation to Identify Nine New Substances of Very High Concern
On September 5, 2017, the European Chemicals Agency ("ECHA") launched a public consultation to identify nine new substances of very high concern ("SVHCs"). The SVHCs are substances that may have serious and often irreversible effects on human health and the environment. If a substance is identified as a SVHC in the European Union, it will be added to the Candidate List for eventual inclusion in the Authorization List (i.e., it is proposed that the use within the European Union be subject to authorization under the REACH Regulation). Member States may propose a substance to be identified as a SVHC by preparing a dossier in accordance with the requirements set out in Annex XV to the REACH Regulation. During the public consultation, all interested stakeholders are invited to submit comments on Annex XV reports. The current public consultation relates to reports for the following new substances: Bisphenol-A, Chrysene, Benzanthracene, Cadmium nitrate, Cadmium hydroxide, Cadmium carbonate, Tricobalt tetraoxide containing ≥ 0.1% w/w nickel oxides, Dechlorane plus, Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde, and 4-heptylphenol, branched and linear (RP-HP). The deadline for comments is October 20, 2017.
EFSA Reviews Safety of Glutamates Added to Food
On July 12, 2017, EFSA issued a report on the re-evaluation of group of glutamates (E 620-625) used as flavor enhancers. EFSA concluded that no adverse effects were observed in the available short-term, subchronic, chronic, reproductive, and developmental studies. However, EFSA stated that glutamates are widely associated with adverse effects, such as headache, raised blood pressure, and increased insulin levels, for some population groups. Thus, EFSA used the available neurodevelopmental toxicity study to derive a group acceptable daily intake ("ADI") of 30 mg/kg bw per day. Importantly, EFSA also noted that the current exposure to glutamate exceeded not only the proposed ADI but also doses associated with the adverse effects mentioned above. EFSA report is likely to lead in the future to the revision of the permitted levels of glutamates in foods in the European Union.
Upcoming Meetings, Workshops and Conferences
Public Meeting of FDA titled "Development of a List of Dietary Ingredients that Pre-Date the Dietary Supplement Health and Education Act of 1994," October 3, 2017, in College Park, MD.
Public Meeting of the Codex Alimentarius Commission Committee on Food Hygiene, October 11, 2017, in Washington, D.C.
Public Meeting of AMS's National Organic Standards Board to assist the USDA in the development of standards for substances to be used in organic production and to advise the Secretary of Agriculture on any other aspects of the implementation of Organic Foods Production Act, October 24, 2017, via webinar; and October 31-November 2, 2017, in Jacksonville, FL.
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