FDA Issues 2009 FDA Food Code

The Food and Drug Administration today announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry.

State, city, county, tribal, and territorial agencies regulate more than 1 million restaurants, retail food stores, and vending and food service operations in institutions such as schools, hospitals, nursing homes, and child care centers.

What FDA Food Code provides

The model FDA Food Code provides the basis for most of those agencies’ licensing, inspection, and enforcement activities, as well as serves as a model for their food statutes, regulations, and ordinances.

The 2009 edition of the Food Code is the seventh full edition published by the FDA. The previous full edition was released in 2005 with a supplement published in 2007.

Significant enhancements to the 2009 FDA Food Code include:

1. Each provision in the FDA Food Code is now designated as a “Priority Item,” a “Priority Foundation Item,” or a “Core Item,” to assist the industry and regulatory community in prioritizing their food safety interventions and their inspections.  These designations are based on a qualitative risk assessment and replace the use of “Critical” and “Non-Critical” designations in previous editions of the FDA Food Code.
2. Cut leafy greens are now included among the foods that require time and temperature control for safety and a new supporting reference document, “Recommendations to Food Establishments for Serving or Selling Cut Leafy Greens,” is summarized in Annex 2.
3. Requirements are added to improve food worker awareness of food allergen concerns in the food service and retail setting.
4. Serving hamburgers and other ground meats in an undercooked form upon a consumer’s request is no longer an option for items offered on a children’s menu.
5. A new definition and criteria are added in a new FDA Food Code section for the non-continuous cooking of foods comprised of raw animal products to address the safety of this cooking method.
6. Several requirements related to the effective cleaning and sanitizing of equipment and surfaces are enhanced or clarified.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189598.htm

 

FDA Amends Labeling Requirements

What final rule requires?

The final rule requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products.

The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs).

Final Rule Requirements

1. Immediate Container Labeling
2. See New Warnings Flag
3. Liver Injury Warning For OTC Acetaminophen Products Containing Multiple Active Ingredients

DATES: Effective Date:

This final rule is effective April 29, 2010.

Compliance Date:

The compliance date for all products subject to this final rule, including products with annual sales less than $25,000, is April 29, 2010.

FOR FURTHER INFORMATION CONTACT:

Arlene Solbeck, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 209930002, 3017962090

Source: http://www.fdanews.com/ext/files/2009-28296_PI.pdf

FDA Issues 22 Warning Letters to Web site Operators

FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.

Reason:

None of the Web sites are for pharmacies in the United States or Canada.

What did the agency issued?

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law.

Guidelines for Secure Use of Social Media by Federal Departments and Agencies, v1.0

Risks

Federal Government information systems are targeted by persistent, pervasive, aggressive threats.

In order to defend against rapidly evolving social media threats, departments and agencies should include a multi-layered approach in a risk management program, including risks to the individual, risks to the department or agency, and risks to the federal infrastructure.

Social media technologies such as Wikis, Blogs, and social networks are vulnerable to the following methods/techniques of cyber attacks: Spear phishing, Social Engineering, and Web Application Attacks

The Threat

Federal Government information systems are targeted by persistent, pervasive, aggressive threats. This is well known and documented, as stated in May of 2009 by Margaret Graves, Acting CIO for the Department of Homeland Security.

Recommendations

The following are a series of strategies and recommendations for federal departments, agencies, and policy makers to minimize risk.

Policy Controls

The safe use of social media is fundamentally a behavioral issue, not a technology issue.

Policy addressing behavior associated with protecting data would likely cover current social media technologies as well as future technologies. Policies for Web 2.0 technologies, blogs, wikis, social media sites, mash-ups, cloud computing, Web 3.0, outsourced e-mail, and other new technologies will remain extensible and applicable.

Acquisition Controls

When Federal agencies use hosted information systems, such as social media websites, they must have some level of risk management, mitigation, and acceptance of residual risk.

Most social media websites have a service subscription model that provides additional capabilities, or may be able to provide federal agencies with additional capabilities for a fee. This has already been demonstrated through modifications to Terms of Service (TOS) agreements by GSA.

http://www.cio.gov/Documents/Guidelines_for_Secure_Use_Social_Media_v01-0.pdf

First anniversary of the 26/11 attacks, Indians mourned the martyrs

http://www.natgeotv.co.in/Programmes/Main.aspx?Id=449

Sarbanes-Oxley Act & Section 302,404,409

The Sarbanes-Oxley Act of 2002 also known as the Public Company Accounting Reform and Investor Protection Act of 2002 is mandatory. ALL organizations, large and small, MUST comply.

Section 302

Corporate responsibility for Financial Activities

Public Company Officers must certify the accuracy of financial statements and must certify that statements fairly present the operations and financialcondition of the issuer.

It also requires material information that is used to generate reports be retained and made available to the public.

It Affects

This directly affects the IT and security departments because it is
primarily IT systems that generate these periodic reports and which control e-mail, the main method of communication within most organizations.

Section 404

Management Assessment of Internal Controls

Section 404 is the most pertinent section within SOX to issues surrounding information security. It addresses the necessity of corporate management to be fully accountable for the integrity of all data associated with their financials.

It states that management teams of public companies must establish and maintain adequate “Internal Controls” over their financial reporting systems to safeguard against unauthorized and improper use of financial information.

Internal Controls are defined as “all control methods a company uses to prevent, detect and correct errors and frauds that might get into financial statements”.

Section 409

Real Time Issuer Disclosure

Public Companies must be aware of, and declare, changes in their financial conditions or operations within 48 hours of material events.  All events which could affect a company’s finances, stock price or intellectual property (among otherthings) must be captured, documented with a process that can be audited and reported in a rapid fashion.

This includes operational risk with IT systems such as:

• Major or extended system outages
• Loss of critical data
• Security breaches
• Intellectual Property and Digital Rights Management issues
• Major computer virus and worm attacks

Pratibha Patil : First woman president to fly in a Sukhoi snaps taken from TV

Pratibha Patil : First woman president to fly in a Sukhoi snaps taken from TV

Pratibha Patil : First woman president to fly in a Sukhoi

Pratibha Patil is making history by becoming the first woman president to fly in a Sukhoi. 74-year-old Patil, who’s in a G-suit, will fly for 30 minutes from the IAF base at Lohegaon in Pune. Two Sukhois will escort the President’s flight

US Visa Types for Temporary Visitors

Check out the types of  Visa for Temporary Visitors into US

*What the abbreviations (above) mean:
Before applying for a visa at a U.S. Embassy abroad the following is required:
DOL = The U.S. employer must obtain foreign labor certification from the U.S. Department of Labor, prior to filing a petition with USCIS.
USCIS = DHS, United States Citizenship and Immigration Services (USCIS) must approve a petition, filed by the U.S. employer (or U.S. citizen, for fiancé petitions)
SEVIS = Program approval entered in the Student and Exchange Visitor Information System (SEVIS)
(NA) = Not Applicable – Means that additional approval by other government agencies is not required prior to applying for a visa at the U.S. Embassy abroad.

Source: http://travel.state.gov/visa/temp/types/types_1286.html

Fastest Growing Energy Companies in Asia & US : Platts report

As per the Platts report

“Asian companies made up more than 20% of the 50 fastest growing companies list, and also took 30% of the top 10 places in the Refining & Marketing category. Reliance Industries and Indian Oil Corporation were first and second, with TonenGeneral Sekiyu of Japan third.”