FDA

Chromium Supplement For Horse Feed Approved: The U.S. Food and Drug Administration (FDA) on March 13, 2020, amended the regulations for food additives permitted in feed and drinking water of animals to expand use of chromium propionate as a source of supplemental chromium, currently approved for use in feed for broiler chickens, to include horse feed. 85 Fed. Reg. 14565. The approval, following a food additive petition filed by Kemin Industries, Inc., limits the level of supplemental chromium in horse feed to not exceed 4 mg of chromium from chromium propionate per horse per day.

FDA Accepting Comments For FAP And CAP Annual Reporting Burdens: On March 17, 2020, FDA announced the opportunity for public comment on the proposed collection of information from submission of food and color additive petitions (FAP and CAP), submission of information to a master file in support of petitions, and electronic submission using Form FDA 3503, as required under the Paperwork Reduction Act of 1995. 85 Fed. Reg. 15188. The estimated annual reporting burden, accounting for two CAPs per year and three FAPs per year, reflecting the average number of petitions received annually over a period of ten years, remains unchanged. FDA is accepting comments until May 18, 2020.

FDA Issues Final Rule Addressing Organizational Change: On March 24, 2020, FDA published a final rule that revises 21 C.F.R. Chapter I to reflect changes to FDA’s organizational structure. 85 Fed. Reg. 16549. The rule, intended to improve the accuracy of FDA’s regulation, is editorial in nature and does not impose any new regulatory requirements on regulated parties. Technical amendments in the rule include replacement of the term “District Director” with “Division Director,” as well as grammatical changes and conforming amendments to accommodate the new terminology. FDA has determined that this rulemaking meets the relevant notice and comment exemption requirements. The rule was effective immediately.

FDA Issues Temporary FSVP Policy During Public Health Emergency: On March 26, 2020, FDA announced the availability of final guidance for industry titled “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency,” which communicates FDA’s intention not to enforce the requirement for an onsite audit in part 117, part 507, and the FSVP regulation in specified circumstances (e.g., region covered by a travel restriction related to COVID-19, an alternative verification activity is undertaken). 85 Fed. Reg. 17008. No deadline or timeframe is included in the guidance document. FDA reportedly intends to provide timely notice about the withdrawal of the temporary policy.

Cancellation Of International Cooperation On Cosmetics Regulation (ICCR) -- Preparation For ICCR-14 Meeting: On March 26, 2020, FDA announced cancellation of the public meeting titled “International Cooperation on Cosmetics Regulation (ICCR) -- Preparation for ICCR-14 Meeting,” due to the COVID-19 public health emergency. 85 Fed. Reg. 17088. As of March 20, 2020, the status of the ICCR-14 meeting itself remains to be determined.

FDA Announces Opportunity For Public Comment On Collection Of Information: On April 3, 2020, FDA announced an opportunity for public comment on the collection of information for the provisions of its Voluntary Cosmetic Registration Program (VCRP). 85 Fed. Reg. 18993. Specifically, FDA is seeking to understand the following.

1. Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

2. the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. ways to enhance the quality, utility, and clarity of the information to be collected; and

4. ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Comments to the proposed collection are due June 2, 2020.

Extension Of Comment Period For FSMA Accreditation Rule: On April 6, 2020, FDA extended the comment period for the “Laboratory Accreditation for Analyses of Foods” proposed rule to July 6, 2020, due to the COVID-19 public health declaration. 85 Fed. Reg.10114.

The Latest COVID-19 Information From FDA: In late March, FDA launched a website offering information and daily updates for the Coronavirus Disease 2019 (COVID-19). The site includes “Daily Roundup” articles, press releases, public statements, frequently asked questions, links to guidance documents, and other information the general public and consumers may find helpful regarding the public health emergency.

NANOTECHNOLOGY

CCOHS Posts Podcast On Hazards Of Nanomaterials And How To Control Exposure: On March 9, 2020, the Canadian Center for Occupational Health and Safety (CCOHS) posted a podcast entitled “The Hazards of Nanomaterials and How to Control Exposure.” CCOHS states that nanomaterials have many useful properties, but the same properties that make them desirable in manufacturing present unique potential safety hazards when workers are exposed to them. In this episode, Todd Irick from the Occupational Health Clinics for Ontario Workers’ Nanotechnology and Health Network explains why nanotechnology is a health and safety concern in the workplace and how exposure to nanomaterials can be controlled.

RIVM Announces Article On Nanoparticle Exposure And Hazard In The Ceramic Industry: On March 16, 2020, the Dutch National Institute for Public Health and the Environment (RIVM) announced publication of an article in the May 2020 issue of Environmental Research entitled “Nanoparticle exposure and hazard in the ceramic industry: an overview of potential sources, toxicity and health effects.” In the article, the researchers provide an overview of the current knowledge on occupational exposure to nanoparticles in the ceramic industry and their impact on human health.

EC Committee Posts Fact Sheet On Guidance On Safety Assessment In Nanomaterials In Cosmetics In French, German, Italian, And Spanish: On March 23, 2020, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) announced that the fact sheet on the SCCS Guidance on the safety assessment of nanomaterials in cosmetics is now available in French, German, Italian, and Spanish. The guidance provides recommendations for the safety assessment of nanomaterials intended for use in cosmetics and covers the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic ingredients.

NNI Releases “Nano Matters” Podcast Episode On Improving Pesticide Use With Nanotechnology: On March 30, 2020, the National Nanotechnology Initiative (NNI) released a “Nano Matters” podcast episode on “Improving Pesticide Use with Nanotechnology.” In the episode, Cristina Sabliov, Professor of Biological and Agricultural Engineering at Louisiana State University, explains how nanotechnology can improve pesticide delivery. She discusses her work on a polymeric nanoparticle delivery system that could reduce the environmental impact of pesticides.

EPA Proposes To Revise SNUR For Functionalized MWCNTs (Generic): EPA published a proposed rule on April 1, 2020, that would amend the significant new use rules (SNUR) for certain chemical substances that were the subject of a premanufacture notice (PMN) and a significant new use notice (SNUN), including functionalized multi-walled carbon nanotubes (MWCNT) (generic). 85 Fed. Reg. 18173. This action would amend the SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions. EPA proposes to amend the SNUR to remove the new uses described in SNUN S-19-5 from the scope of the significant new use and remove the new uses described in SNUN S-18-4 from the scope of the significant new use, except where that use does not include the protective measures described in the TSCA Order for S-18-4. Comments are due May 1, 2020. More information is available in our April 1, 2020, blog item.

NIOSH Posts Posters On 3D Printing With Filaments, Metal Powders: The National Institute for Occupational Safety and Health (NIOSH) has posted two posters from the NIOSH Nanotechnology Research Center (NTRC) on 3D printing: 3D Printing with Filaments: Health and Safety Questions to Ask and 3D Printing with Metal Powders: Health and Safety Questions to Ask. The posters provide health and safety questions with different control options and information intended to reduce exposure to potential hazards.

EUON Announces That Female Fertility Data Are Lacking For Nanomaterials: The European Union (EU) Observatory for Nanomaterials (EUON) posted an article on April 6, 2020, announcing the availability of a study that found a lack of data on female fertility. The study, A critical review of studies on the reproductive and developmental toxicity of nanomaterials, was commissioned by the European Chemicals Agency (ECHA) and carried out by DHI A/S and the Danish National Research Center for the Working Environment. More information is available in our April 10, 2020, blog item.

National Academies Publish Quadrennial Review Of NNI: The National Academies of Sciences, Engineering, and Medicine (National Academies) have published a prepublication copy of A Quadrennial Review of the National Nanotechnology Initiative: Nanoscience, Applications, and Commercialization. The National Nanotechnology Coordination Office (NNCO) asked the National Academies to form an ad hoc committee to conduct a quadrennial review of the NNI. The statement of task was to analyze the relative position of the U.S. nanotechnology program relative to the programs of other nations, determine whether NNI coordination should continue, and if it should, identify how to improve the NNI’s research and development (R&D) strategy and R&D portfolio to enhance further the economic prosperity and national security of the United States. The report identifies changes to NNI intended to “promote a resurgence of the nation’s nanotechnology program and enable it to respond to the dynamic changes of the new global research environment in which it functions.”

ISO Publishes Standard Specifying Characteristics And Measurement Methods For Air Filter Media Containing Polymeric Nanofibers: The International Organization for Standardization (ISO) has published standard ISO/TS 21237:2020, “Nanotechnologies -- Air filter media containing polymeric nanofibres -- Specification of characteristics and measurement methods.” According to ISO, in recent years, air filter media containing nanofibers have been commercialized and widely used by different industries due to their high filtration efficiency, along with a low pressure drop created by the slip flow effect. ISO states that the standard is intended to facilitate communication between sellers and buyers and to support the growing trade of this new class of air filter media.

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C^® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG^®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.