FDA Foreign Supplier Verification Programs (FSVP)
U.S. Customs & Border Protection
FSMA mandated the creation of a food safety system that places primary focus on preventing problems versus reacting to problems after they occur. The provisions established under FSMA include the creation of preventive controls for the production of human and animal foods, risk-based activities for verification of food safety standards, science-based safety standards for produce grown on farms, and preventive practices related to sanitary transportation of human and animal foods. The provisions apply to both domestic food producers and to those located in foreign countries who export food into the United States.
The import community will primarily be impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers verify the food they import meets U.S. safety standards. For the purpose of FSVP, the importer is defined as the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it). If there is no U.S. owner or consignee at time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee.
An informational FSVP fact sheet has been posted on FDA’s website and may be accessed through the following website link:
FSVP At-A-Glance: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM502160.pdf
For more information regarding the Final Rule on FSVP, FSMA compliance dates, and other FSMA provisions, please visit the following website links:
FSMA Final Rule FSVP: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm
FSVP Compliance Dates: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm
FSMA Provisions: http://www.fda.gov/food/guidanceregulation/fsma/default.htm
Join the Global Entry Movement
U.S. Customs & Border Protection
DETROIT— The Global Entry program is running full speed ahead and is enjoying an overwhelming success in the international travel environment. U.S. Customs & Border Protection (CBP) encourages international travelers to sign up for Global Entry and enjoy expedited processing at Detroit Metropolitan Airport.
Global Entry is a CBP program that allows expedited clearance for pre-approved, low-risk international travelers upon arrival in the United States. The Global Entry program also benefits CBP and participating foreign governments by allowing them to focus efforts on potentially higher risk air travelers, thereby facilitating the movement of trusted travelers in a more efficient and effective manner.
“Global Entry participants benefit from expeditious processing and direct exiting to either a connecting flight or a final destination in the Detroit area,” said Devin Chamberlain, Port Director. “Global Entry members are also eligible to expedite their domestic travels by using TSA’s Pre✓™ trusted traveler screening lines.”
With fifteen kiosks located at Metro Airport, Global Entry participants enjoy reduced wait times and no paperwork.
Travelers who want to learn more about the Global Entry program can obtain information from the CBP website.
FDA Updates Draft Guidance on Premarket Safety Notifications for Dietary Supplement Industry - Food & Drug Administration
The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient (one that was not marketed in the United States before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.
The FDA estimates that there are more than 55,600 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year. However, the agency has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994. An initial draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” was released in 2011. After considering the feedback received on that draft, the FDA revised the draft guidance to clarify several important points that were misunderstood or not fully explained, to describe the public health significance of the recommendations, and to request additional comment before publishing a final guidance.
“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs. “Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”
Over the past three years, the FDA has taken numerous actions on dietary supplements, including action on several products containing new dietary ingredients that pose safety concerns and should have been the subject of an NDI notification but were not, such as Acacia rigidula.
In December 2015, the agency announced the creation of the Office of Dietary Supplement Programs, elevating the program from its previous status as a division under the former Office of Nutrition, Labeling and Dietary Supplements (now Office of Nutrition and Food Labeling). As part of that action, the agency reaffirmed its commitment to remove from the market products that contain potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely labeled as dietary supplements; enforce the dietary supplement good manufacturing practices regulation; and take action against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or economic fraud.
A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.
The FDA encourages public comments on the revised draft guidance during the 60-day comment period.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
USDA Announces Revision of 41 U.S. Fruit and Vegetable Standards for Grade - U.S. Department of Agriculture
The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced revised U.S. Grade Standards for Fresh Fruits and Vegetables, Fruits and Vegetables for Processing, Nuts, and Specialty Crops.
The revision eliminates the “Unclassified” section and removes a category that is not a grade and only shows that no grade has been applied to the lot. The revisions bring the grade standards in line with current terminology and marketing practices, and provide the industry with increased flexibility.
The notice announcing the revision is in the August 4, 2016, Federal Register. For a copy of the current standards or more information, visit www.ams.usda.gov/grades-standards/vegetables, or contact Olivia Vernon by phone: (540) 361-1127, e-mail: olivia.vernon@ams.usda.gov, or U.S. mail: Standardization Branch, Specialty Crops Inspection Division, Specialty Crops Program, AMS, USDA, National Training and Development Center, Riverside Business Park, 100 Riverside Parkway, Suite 101, Fredericksburg, Va. 22406.
FMCSA Issues Safety Advisory Related to the Possession and Use of Battery-Powered Portable Electronic Smoking Devices in or Around Commercial Motor Vehicles - Federal Motor Carrier Safety Commission
The Federal Motor Carrier Safety Administration (FMCSA) is issuing a Safety Advisory to provide notice and information to owners and operators of commercial motor vehicles (CMVs) concerning incidents that have occurred relating to the possession and use of battery-powered portable electronic smoking devices [e.g., e-cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers, electronic nicotine delivery systems] and the transportation safety risks associated with the use of these devices. The use of battery-powered portable electronic smoking devices has resulted in incidents including explosions, serious personal injuries, and fires. The explosions regularly involved the ejection of a burning battery case or other components from the device which subsequently ignited nearby flammable or combustible materials. The Federal Hazardous Materials Regulations and Federal Motor Carrier Safety Regulations do not specifically address the potential safety risks posed by battery-powered portable electronic smoking devices. However, motor carriers and drivers should be cognizant of the risks associated with these devices and exercise good judgment and appropriate discretion in their possession, storage, and charging or use on, around, or while operating a CMV, and adhere to the smoking prohibitions on, near, or when loading and unloading a motor vehicle transporting hazardous materials in accordance with 49 CFR 177.834(c) and 397.13. Click here to read the full Safety Advisory.
CBP Brings to Light Meth Buried in Religious Candle - U.S. Customs & Border Protection
LOS ANGELES — U.S. Customs and Border Protection (CBP) Field Operation officers from Los Angeles International Airport stationed at an Ontario air cargo facility discovered crystal methamphetamine concealed within a false cavity of a hollowed out candle on Aug. 3. The estimated value of the seized 1.6 pounds of crystal meth is $23,000.
CBP officers examined an express parcel from Mexico destined to Mills Spring, North Carolina. It contained a large religious candle that was unusually heavy and a boy’s cotton suit.
X-ray images revealed a false cavity concealing a large object within the candle. The bottom of the candle was carefully carved out, revealing a dark-blue cylinder shaped object. With a small incision, officers extracted a white-crystal substance that tested positive for crystal methamphetamine.
“Our officers are very mindful of an individual’s property including spiritual items, yet they remain focused on keeping dangerous drugs off the streets of our community,” said Mitchell Merriam, CBP Los Angeles Area Port Director.
The two items were seized by CBP and turned over to U.S. Immigration and Customs Enforcement Homeland Security Investigations special agents for further investigation.
USITC Will Expedite Five-Year (Sunset) Review Concerning Hot-Rolled Flat-Rolled Carbon-Quality Steel Products from Russia
United States International Trade Commission
The U.S. International Trade Commission (USITC) has voted to expedite its five-year (“sunset”) review concerning the antidumping duty order on hot-rolled flat-rolled carbon-quality steel products from Russia.
As a result of the vote, the Commission will conduct an expedited review to determine whether revocation of the order would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
The Uruguay Round Agreements Act requires the Department of Commerce to revoke an antidumping or countervailing duty order, or terminate a suspension agreement, after five years unless the Department of Commerce and the USITC determine that revoking the order or terminating the suspension agreement would be likely to lead to continuation or recurrence of dumping or subsidies (Commerce) and of material injury (USITC) within a reasonably foreseeable time.
The Commission’s notice of institution in five-year reviews requests that interested parties file with the Commission responses that discuss the likely effects of revoking the order under review and provide other pertinent information. Generally within 95 days from institution, the Commission will determine whether the responses it has received reflect an adequate or inadequate level of interest in a full review. If responses to the USITC's notice of institution are adequate, or if other circumstances warrant a full review, the Commission conducts a full review, which includes a public hearing and issuance of questionnaires.
The Commission generally does not hold a hearing or conduct further investigative activities in expedited reviews. Commissioners base their injury determinations in expedited reviews on the facts available, including the Commission’s prior injury and review determinations, responses received to its notice of institution, data collected by staff in connection with the reviews, and information provided by the Department of Commerce.
Chairman Irving A. Williamson and Commissioners Dean A. Pinkert, David S. Johanson, Meredith M. Broadbent, F. Scott Kieff, and Rhonda K. Schmidtlein concluded that the domestic group response for this review was adequate and the respondent group response was inadequate and voted for an expedited review.
A record of the Commission’s vote on this matter is available from the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Requests may be made by telephone by calling 202-205-1802.
The record of the Commission's vote is also posted on the USITC's Internet site at http://pubapps2.usitc.gov/sunset/caseProf/list?sort=caseTitle&order=asc. From this page, search " hot-rolled flat-rolled carbon-quality steel products" using the search box in the upper right corner.
The Federal Register notice will indicate whether any further information or statements will be available. Only parties that filed adequate responses and filed timely notices of appearance are eligible to participate further in this review. The Commission will issue a report after it completes its review.