Customer Service Advisory: POLA and POLB Marine Terminal Gates Closed on Thursday, November 7, 2013 at 5 p.m.
PierPass Inc. / http://pierpass.org/2013/10/30/customer-service-advisory-pola-and-polb-marine-terminal-gates-closed-on-thursday-november-7-2013-at-5-p-m/
PierPass Inc. has been notified that the International Longshore and Warehouse Union (ILWU) will observe a special stop work meeting for union business Thursday, November 7, 2013 starting at 5 p.m. As a result, no marine terminal gates at the Port of Los Angeles and the Port of Long Beach will operate between the hours of 5:00 p.m. on November 7 through 3:00 a.m. on November 8. There will be no OffPeak shift Thursday night.
There will be no replacement shift.
This labor shutdown falls under Rule 5 of the Marine Terminal Operator Schedule No. 1, which is available at:
https://www.pierpass-tmf.org/Documents/Marine_Terminal_Schedule.pdf
San Diego Tunnel Task Force Uncovers Underground Passageway Linking San Diego and Tijuana
U.S. Homeland Securty/ICE / http://www.ice.gov/news/releases/1310/131031sandiego.htm
Investigators on the San Diego Tunnel Task Force have uncovered a just completed, highly sophisticated underground passageway linking San Diego and Tijuana. Enforcement actions related to this discovery are still underway. In order to ensure the integrity of the ongoing investigation and the safety of those involved, we are not providing additional details at this time. We will make a public announcement and provide further information about the case as soon as it is appropriate to do so. The San Diego Tunnel Task Force is comprised of U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, U.S. Customs Border Protection Border Patrol, and the Drug Enforcement Administration.
Commerce Initiates Antidumping Duty Investigations of Imports of Grain-Oriented Electrical Steel from the People’s Republic of China, the Czech Republic, Germany, Japan, the Republic of Korea, Poland and the Russian Federation and a Countervailing Duty Investigation of Imports of Grain-Oriented Electrical Steel from the People’s Republic of China
International Trade Adminisration / http://www.trade.gov/press/press-releases/
Fact Sheet:
Monosodium Glutamate from China and Indonesia
International Trade Admnistration / http://www.trade.gov/press/press-releases/
Fact Sheet
USITC Votes to Continue Cases on Chlorinated Isocyanurates from China and Japan
United States International Trade Commission / http://www.usitc.gov/press_room/news_release/2013/er1029ll1.htm
The United States International Trade Commission (USITC) today determined that there is a reasonable indication that a U.S. industry is materially injured by reason of imports of chlorinated isocyanurates that are allegedly sold in the United States at less than fair value by Japan and allegedly subsidized by China.
Chairman Irving A. Williamson and Commissioners Dean A. Pinkert, David S. Johanson, and Meredith M. Broadbent voted in the affirmative. Commissioners Shara L. Aranoff and F. Scott Kieff did not participate in these investigations.
As a result of the Commission's affirmative determinations, the U.S. Department of Commerce will continue to conduct its investigations on imports of these products, with its preliminary countervailing duty order concerning China due on or about December 9, 2013, and its preliminary antidumping duty order concerning Japan due on or about February 21, 2014.
The Commission's public report Chlorinated Isocyanurates from China and Japan (Inv. Nos. 701-TA-501 and 731-TA-1226 (Preliminary), USITC Publication 4431, November 2013) will contain the views of the Commission and information developed during the investigations.
Copies of the report are expected to be available after November 29, 2013, by emailing pubrequest@usitc.gov, calling 202-205-2000, or writing to the Office of the Secretary, 500 E Street SW, Washington, DC 20436. Requests may also be faxed to 202-205-2104.
FDA Moves to Keep Foods Safe for Animals
Food & Drug Administration / http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm371395.htm
For the first time, the Food and Drug Administration (FDA) is proposing preventive measures to protect all animal foods from disease-causing bacteria, chemicals and other contaminants.
This includes the food that pet owners give their dogs, cats and other companion animals, and the feed that farmers give their livestock.
Preventive Controls for Food for Animals is the fifth rule that FDA has proposed this year as part of the food-safety framework envisioned by the 2011 FDA Food Safety Modernization Act that focuses on preventing foodborne illnesses.
Daniel McChesney, Ph.D., director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine (CVM), explains that this rule proposes establishing a whole new set of protections for animal foods. Currently, the agency primarily gets involved when there is evidence of contaminated animal food on the market.
“Unlike safeguards already in place to protect human foods, there are currently no regulations governing the safe production of most animal foods. There is no type of hazard analysis. This rule would change all that,” says McChesney.
McChesney notes that human and animal health are intertwined. People can get sick when pet food is contaminated by disease-causing bacteria like Salmonella. When such food is handled by pet owners and placed on kitchen surfaces, the bacteria can spread to foods consumed by their family.
And if an animal has eaten feed contaminated with a chemical like dioxin and then enters the food supply, consumers could likewise absorb the chemical, putting their health at risk.
By helping to prevent the contamination of animal foods, the proposed rule protects pets and people alike, he says.
Requiring a Safety Plan
This proposed rule would create regulations that address the manufacturing, processing, packing and holding of animal food. Good manufacturing practices would be established for buildings, facilities and personnel, and would include cleaning and maintenance, pest control, and the personal hygiene of people who work there.
It would also require facilities to have a food safety plan, perform an analysis of potential hazards, and implement controls to minimize those risks. Those controls would have to be monitored and corrected as needed.
While this rule is similar in many ways to the Preventive Controls for Human Food rule that FDA proposed in January 2013, McChesney explains that it is different in a number of ways because animals face different hazards.
For example, he says, the proposed animal rule doesn’t address allergens—substances that could cause an allergic reaction. That’s because animals don’t get the kind of life-threatening allergic reactions that people do. They might get a skin reaction but not the kind of physical shock that a food allergen could trigger in a person.
On the other hand, contaminants that endanger animals are sometimes tolerated better by people and were not as great a concern in crafting protections for human food. For example, some animals are much more vulnerable to aflatoxin, a toxin caused by mold, and could die after consuming food containing the toxin.
The animal rule is also designed to prevent nutrient imbalances in animal foods. Unlike people, who get their foods from many sources, an animal’s food is meant to be a complete and balanced diet, explains McChesney. If a food doesn’t have enough of a particular nutrient, the animal has no way to make it up. For example, cats need thiamine (also known as Vitamin B1) but their bodies don’t produce it. If they don’t get enough in their food, they can suffer severe neurological problems.
The proposed rule has been published in the Federal Register, with a 120-day public-comment period. The rule is filed in FDA's official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.
Import Rules Add Safeguards
The proposed animal rule would work in concert with two rules proposed in July 2013 to help ensure that foods exported to the United States are held to the same FDA food safety standards applied to foods produced in the United States. Together, the three rules would help ensure the same level of safety for domestic and imported foods for animals.
In one of the most infamous examples of pet food contamination, dogs and cats across the country were sickened and killed in 2007 when melamine, a chemical used to make plastic, was added to pet food ingredients imported from China. McChesney noted that FDA received about 18,000 calls from anxious pet owners at the time.
The requirements proposed in both the animal and import rules are designed to help prevent that from happening again, he says.
Overall, McChesney says that the animal food supply is very safe. However, with the marketplace becoming more global and more diverse, more protections are needed. When you buy food for your animals, those ingredients could come from anywhere in the world, so animal food producers and their suppliers, no matter where they are based, have to be held to the same high standards, he says.
“Whether in the home or on the farm, people take the safety of their animals very seriously, and so do we,” says McChesney.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
FDA Takes Two Important Actions on Drug Shortages
U.S. Food & Drug Administration / http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373044.htm
Strategic plan and proposed rule on early notification by manufacturers will help agency build on recent progress
The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages1, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011.
Today’s announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.
Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic2 products. The proposed rule implements the expanded early notification3 requirements included in FDASIA.
“The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.”
Early notification gives the FDA time to:
- work with manufacturers to investigate the issue leading to the manufacturing disruption;
- identify other manufacturers who can make up all or part of the shortfall; and
- expedite inspections and reviews of submissions from manufacturers of drugs that may prevent or mitigate a shortage.
Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 of Oct. 31, 2011 and then codified into law in FDASIA, has enabled the FDA to work with manufacturers to restore production of many lifesaving therapies. Since the Executive Order, there has been a 6-fold increase in notifications to the FDA.
The notifications received under the existing requirements have resulted in real progress in addressing shortages. The FDA helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of new shortages in 2012. The expanded early notification requirements would further enhance the FDA’s ability to address issues prior to the occurrence of a shortage.
The strategic plan, which was required by FDASIA and is being sent to Congress today, describes actions the FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage. These include:
- improving the FDA’s communications about shortages, such as launching a new mobile app, so that individuals can instantaneously access drug shortage information via their smart phones;
- clarifying manufacturers’ roles and responsibilities by encouraging them to engage in certain practices that will reduce the likelihood of a shortage; and
- updating the FDA’s internal procedures for responding to early notifications of potential shortages.
The strategic plan also describes efforts the FDA is considering to address the manufacturing and quality issues that are most often the root cause of drug shortages. These include:
- broader use of manufacturing metrics to assist in the evaluation of manufacturing quality, as well as incentives for high-quality manufacturing;
- internal organization improvements to focus on quality, including a proposed Office of Pharmaceutical Quality within CDER; and
- risk-based approaches to identify early warning signals for manufacturing and quality problems.
The FDA has established a separate docket for the public to provide comment on the
proposed rule.