March 28, 2018

Federal Register

Food and Drug Administration

Rules

Good Guidance Practices; Technical Amendment

Filed on: 03/28/2018 at 08:45 am Scheduled Pub. Date: 03/29/2018

FR Document: 2018-06252 PDF 3 Pages (8.24 KB) Permalink

Animal and Plant Health Inspection Service

Rules

Importation of Fresh Cherimoya Fruit From Chile Into the United States

Filed on: 03/28/2018 at 08:45 am Scheduled Pub. Date: 03/29/2018

FR Document: 2018-06289 PDF 13 Pages (115 KB) Permalink

Proposed Rules

Importation of Pummelo From Thailand Into the Continental United States

Filed on: 03/28/2018 at 08:45 am Scheduled Pub. Date: 03/29/2018

FR Document: 2018-06288 PDF 12 Pages (125 KB) Permalink

Notices

Chronic Wasting Disease Herd Certification Program Standards

Filed on: 03/28/2018 at 08:45 am Scheduled Pub. Date: 03/29/2018

FR Document: 2018-06341 PDF 5 Pages (177 KB) Permalink

Agricultural Marketing Service

Rules

Decreased Assessment Rates:

Oranges and Grapefruit Grown in the Lower Rio Grande Valley in Texas

Filed on: 03/28/2018 at 08:45 am Scheduled Pub. Date: 03/29/2018

FR Document: 2018-06282 PDF 15 Pages (250 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
03/27/2018	Wegmans	Yogurt Raisins	May contain undeclared peanuts	First Source, LLC
03/26/2018	eBars	Energy Bars	May contain undeclared peanut and/or almond allergens	eBars LLC

AskFSIS

Donating Retail Dealer, Poultry Producer or Other Person, or a Small Enterprise, or Retail Store Exempt Poultry Product

Donating Individual Slaughter and Custom Exempt Meat and Poultry Product

AMS

Colorado Firm Posts $175,000 Surety Bond to Obtain PACA License

NIH

Potassium Fact Sheet for Health Professionals

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

• · DYK? #FDAORA issues public notifications for tainted products for sexual enhancement, weight loss, arthritis/pain & body building. LEARN MORE about these tainted supplement products: https://go.usa.gov/xn7Yt #healthfraud
• · eBars Issues Allergy Alert on Undeclared Allergens http://dlvr.it/QMYHb6
• · Food safety is important for everyone – but it’s especially important for you if you've been diagnosed w/ diabetes. So this #DiabetesAlertDay be sure to check out the Food Safety Guide we put together w/ @USDAFoodSafety https://go.usa.gov/xQCPC
• · UPDATE: FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., including Darwin’s Natural Pet Products & ZooLogics Pet Food https://go.usa.gov/xQCP4 #rawpetfood#
• · First Source Issues Allergy Alert on Undeclared Peanuts in Wegmans 9 Oz Yogurt Raisins http://dlvr.it/QMbQWT

March 29, 2018

Federal Register

Food and Drug Administration

Rules

New Animal Drugs:

Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06358 PDF 14 Pages (125 KB) Permalink

Withdrawal of Approval of New Animal Drug Applications

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06357 PDF 2 Pages (85.3 KB) Permalink

Food and Nutrition Service

Rules

Supplemental Nutrition Assistance Program:

Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation and Energy Act of 2008; Correction

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06520 PDF 4 Pages (223 KB) Permalink

Food Safety and Inspection Service

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06469 PDF 8 Pages (183 KB) Permalink

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Consumer Complaint Monitoring System

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06467 PDF 8 Pages (205 KB) Permalink

Animal and Plant Health Inspection Service

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Importation of Gypsy Moth Host Materials from Canada

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06511 PDF 4 Pages (161 KB) Permalink

Infectious Salmon Anemia; Payment of Indemnity

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06514 PDF 4 Pages (97.8 KB) Permalink

Petitions for Determinations of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide:

BASF Plant Science, LP

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06399 PDF 6 Pages (182 KB) Permalink

Agricultural Marketing Service

Proposed Rules

Assessment Rate Computations:

Peanut Promotion, Research, and Information Order

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06283 PDF 19 Pages (154 KB) Permalink

Marketing Orders:

Milk in the Florida Marketing Area

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06286 PDF 38 Pages (403 KB) Permalink

Environmental Protection Agency

Rules

Tolerance Exemptions:

N,N-Dimethyl 9-Decenamide; N,N-Dimethyldodecanamide; N,N-Dimethyltetradecanamide

Filed on: 03/29/2018 at 08:45 am Scheduled Pub. Date: 03/30/2018

FR Document: 2018-06108 PDF 26 Pages (228 KB) Permalink

FDA

We’re Committed to Guarding Against the Intentional Adulteration of Food and Implementing the New Rule Efficiently

Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

FSIS

026-2018 Tony Downs Food Company, Inc. Recalls Chicken Products due to Possible Foreign Matter Contamination

AskFSIS

Making Data Corrections to Import Applications in PHIS

Verification HACCP record requirements

Part 1 of 2: Recommendations For Establishment That Cannot Meet The 2017 Stabilization Guideline Revised Appendix B

Part 2 of 2: Recommendations For Establishments That Cannot Meet The 2017 Stabilization Guideline Revised Appendix B

APHIS

APHIS Revises Chronic Wasting Disease Program Standards

Secretary Perdue Issues USDA Statement on Plant Breeding Innovation

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

• · DYK #FDAORA has a lab in Arkansas? Among other things, the Arkansas Laboratory tests foods to ensure they don’t contain pesticides that are unsafe for you to eat. MORE: https://go.usa.gov/xnsTH #FDAinyourstate
• · Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs: http://go.usa.gov/xQCtq
• · .@FDAfood Jenny Scott kicks off panel and shares that FDA refers to root cause analysis as environmental assessments #CFAFPC
• · Check out the March 28th edition of our FDA Patient Network Newsletter and stay up to date on news, announcements and so much more! https://go.usa.gov/xnyRA
• · World Veterinary Day is April 28th! Learn more about CVM’s international counterparts here: https://go.usa.gov/xQr3e
• · Planning, shopping, cooking, eating we can help make it healthier #NationalNutritionMonth https://pin.it/fedpyhap7rvq7d
• · FDA Commissioner @SGottliebFDA will give the keynote address at the 41st Annual National Food Policy Conference. He will discuss new details on FDA’s comprehensive Nutrition Innovation Strategy. Watch the livestream here: https://www.facebook.com/pg/ConsumerFederationofAmerica/videos/?ref=page_internal#CFAFPC …
• · “Improvements in diet and nutrition offer us one of our greatest opportunities to have a profound and generational impact on human health. And, FDA has a critical role to play to make this happen.” @SGottliebFDA #CFAFPC
• · “As a parent of three young girls, I share in the challenges busy, stressed families encounter daily in encouraging healthy eating.” @SGottliebFDA #CFAFPC
• · “FDA regulates 80% of our country’s food supply, and we take this important role in our nation’s health very seriously. That’s why I’m announcing a comprehensive multi-year Nutrition Innovation Strategy…” @SGottliebFDA #CFAFPC
• · “Consumers value healthful ingredients 4x as much as brand recognition. The food industry is innovating to give people more of what they want.” @SGottliebFDA #CFAFPC
• · “Identifying and encouraging food patterns that are consistent with the dietary guidelines, affordable and appealing is also a priority to fight social inequalities in health.” @SGottliebFDA #CFAFPC
• · “We’re opening a docket and are holding a public meeting this summer where we can advance proposals to modernize our approach to better protect public health while removing barriers to innovation.” @SGottliebFDA #CFAFPC
• · “We’re asking what more we can do to encourage meaningful claims that reflect the latest nutrition science and could spur industry to introduce products that qualify for those claims. Healthy is one claim we believe is ripe for change.” @SGottliebFDA #CFAFPC
• · “As another action step, we’ll streamline our process for reviewing qualified health claims we receive from industry.” @SGottliebFDA #CFAFPC
• · “A second prong of our plan is to re-evaluate the ingredient information on food packages. Consumers want clean labels that are readable and understandable.” @SGottliebFDA #CFAFPC
• · “We need to finish our work on menu labeling… Beginning on May 7, consumers can walk into covered eating establishments across the country and know at a glance how many calories are in the foods they order for themselves and their kids.” @SGottliebFDA #CFAFPC
• · “We’re launching a major educational campaign for consumers surrounding the new nutrition information consumers will be seeing in the marketplace... including resources that put calorie information into context .” @SGottliebFDA #CFAFPC
• · “It’s important we take a fresh look at existing standards of identity in light of marketing trends and the latest nutritional science.” @SGottliebFDA #CFAFPC
• · “Excess sodium in the diet results in hypertension, which increases the risk of strokes and heart attacks… I’m committed to advancing the short-term voluntary sodium targets.” @SGottliebFDA #CFAFPC
• · “We plan to release the updated short-term targets in 2019, as well as continuing the dialogue on longer-term reduction efforts.” @SGottliebFDA #CFAFPC
• · “Like our efforts to reduce tobacco use, our work in nutrition can do much to reduce the burden of chronic disease and the early death we see as a result of avoidable illness.” @SGottliebFDA #CFAFPC
• · FDA Commissioner @SGottliebFDA gave the keynote address at the 41st Annual National Food Policy Conference. He discussed new details on FDA’s comprehensive Nutrition Innovation Strategy. https://go.usa.gov/xQrB5
• · #ICYMI: View #FDAORA enforcement, inspections, and criminal investigations stats from 2017: https://go.usa.gov/xntmK

March 30, 2018

Federal Register

Food and Drug Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Regulations under the Federal Import Milk Act

Filed on: 03/30/2018 at 08:45 am Scheduled Pub. Date: 04/02/2018

FR Document: 2018-06595 PDF 8 Pages (112 KB) Permalink

Food and Nutrition Service

Notices

Emergency Food Assistance Program:

Availability of Foods for Fiscal Year 2018

Filed on: 03/30/2018 at 08:45 am Scheduled Pub. Date: 04/02/2018

FR Document: 2018-06177 PDF 5 Pages (171 KB) Permalink

Agricultural Marketing Service

Proposed Rules

Milk in California:

Establishment of Federal Milk Marketing Order

Filed on: 03/30/2018 at 08:45 am Scheduled Pub. Date: 04/02/2018

FR Document: 2018-06167 PDF 244 Pages (1 MB) Permalink

FDA

FDA Commissioner Scott Gottlieb Delivers Nutrition Speech at National Food Policy Conference

Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
03/29/2018	Healthy Nut Factory	Organic Coconut Smiles	May contain Salmonella	The Health Nuts
03/29/2018	Archer Farms, Ben & Jerry’s, Breyers, C&W	Various frozen items	Not held at appropriate temperature	Target Corporation

FNS

USDA Expands Focus on Program Integrity Across All Nutrition Programs

FSIS

FY 2018 Yearend Closing Instructions

027-2018 Target Corporation Recalls Frozen Ready-To-Eat and Non-Ready-To-Eat Meat and Poultry Products due to Possible Temperature Abuse During Transport at a Single Store on Oahu, Honolulu, HI

AskFSIS

Determining APC Swab Test Limits

Addressing Aerobic Plate Count (APC) Testing in the Hazard Analysis In An Establishment That Utilizes LTD Sanitation Procedures

Less Than Daily Sanitation in Other Areas Within The Establishment

Intent of Gross Contamination Language in Directive 5000.5

Establishments Conducting LTD Sanitation Procedures

Questions posted on askFSIS

Answers Received from askFSIS Agency Staff

Finished Products Standards Poultry testing

APHIS

APHIS Proposes to Allow the Importation of Fresh Pummelo Fruit from Thailand into the Continental United States

USDA Publishes Final Rule to Allow the Importation of Fresh Cherimoya Fruit from Chile

CSPI

Food and Drug Administration Offers Promising Nutrition Innovation Strategy

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

• · Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA: http://go.usa.gov/xQr9Z
• · FDA Commissioner @SGottliebFDA introduced FDA’s Nutrition Innovation Strategy @ today’s #CFAFPC. Learn more about the Nutrition Innovation Strategy & ways FDA is exploring to reduce preventable death & disease through improved nutrition: https://go.usa.gov/xQr8e
• · #TBT In the mid-1970s, FDA’s all-female crew of consumer consultants educated the public about FDA programs like “Read the Label, Set a Better Table.” Educational materials included film and radio spots http://bit.ly/2DI1BpY #womenshistorymonth
• · #FDA’s comprehensive nutrition plan, announced today, is a fundamentally new strategic initiative and reframing of the agency’s view on importance of nutrition as a tool for public health — and a detailed new agenda for how we will build on that mission
• · Cooking eggs for #Passover Seder? FDA has important advice to keep your family safe from #food-borne illness ⇨ http://go.usa.gov/xnPr9
• · #FDA announced new plans today for getting better information on food packages and the how the agency is looking for ways to clarify ingredient lists on the packages.
• · Like our efforts around tobacco, @US_FDA comprehensive new nutrition strategy is one of our greatest opportunities to have a profound and generational impact on human health. https://go.usa.gov/xQrB5
• · Good nutrition is a fundamental opportunity to improve public health. We can address broader societal challenges by meeting this goal, empower consumers with info, and facilitate industry innovation toward healthier foods https://go.usa.gov/xQrB5
• · Among new policies #FDA announced today as part of its nutrition plan, we’re taking fresh look at existing food standards of identity, given marketing trends and nutritional science, to see what needs modernizing, what standards may no longer be necessary https://go.usa.gov/xQrB5
• · The #FDA’s new nutrition strategy aims to provide consumers with “clean labels” that are readable and understandable. We’re considering what changes could make ingredient information on food packages more consumer friendly. https://go.usa.gov/xQrB5
• · Target Corporation Issues a Voluntary Recall For a Variety of Frozen Products Sold at a Single Store on Oahu http://dlvr.it/QMq2Zh
• · #FDA’s new strategic initiative on nutrition aims to use nutrition and information on foods and diets as a way to address chronic disease and reduce societal disparities that are exacerbated by inequalities in access to good foods
• · Cooking ham this #spring? Cook smoked ham to a safe internal temp of 145 °F. Learn more about ham cooking times: http://go.usa.gov/xXnda
• · Think you are too busy to eat healthy? You can save time & money by planning meals. Try using our 2-week menu! http://bit.ly/2jLhik4 #NationalNutritionMonth
• · Health Nut Factory Recalls Organic Coconut Smiles Because Of Possible Health Risk http://dlvr.it/QMqs8B
• · Really good to see this pick up steam. Americans with less wealth and education need better information & CFSAN can do the job. @DukeForge @DrMayneFDAFood

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