FSMA Notes…..

The FDA has enacted new legislation on the FSMA but they claim repeatedly they do not regulate ‘meat’ – the USDA does. Still looking for USDA changes for FSMA… Needed to stash notes

Agro-Defense: Responding to Threats Against America’s Agriculture and Food System
Statement of
Ted Elkin
Director, Office of Food Defense
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Department of Health and Human Services
Before the
Committee on Homeland Security and Governmental Affairs
Subcommittee on Oversight of Government Management, the Federal Workforce,
and the District of Columbia
U.S. Senate
September 13, 2011
FDA’S Role in Food-Related Counterterrorism Activities

FDA is the federal agency that regulates all of the food we eat except for meat, poultry, and processed egg products, which are regulated by our partners at the U.S. Department of Agriculture (USDA). FDA also is responsible for regulating tobacco products and ensuring that human drugs, human biological products, medical devices, and radiological products, as well as veterinary drugs, are safe and effective and that cosmetics are safe.
Collaboration With Food Safety and Food Defense Partners
In its food safety and defense efforts, FDA has many partners—federal, state, local, tribal, and territorial agencies; academia; and industry. FDA is working closely with our federal partners, such as USDA, the Department of Homeland Security (DHS), the Homeland Security Council at the White House, the Department of State, the Central Intelligence Agency (CIA), and the Federal Bureau of Investigation (FBI), to have the best information possible and to be prepared to act as needed.

FDA has been working closely with DHS and other federal agencies to implement the Homeland Security Presidential Directives (HSPDs). The Secretary of DHS is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the nation, including food and agriculture defense. HSPD-7, 8, and 9 identify critical infrastructures, improve response planning, and establish a national policy to defend the agriculture and food systems against terrorist attacks, major disasters, and other emergencies.

To implement HSPD-9, the HHS and USDA Secretaries or their designees exercise key responsibilities as food sector-specific agencies. DHS serves as the coordinator of the Food and Agriculture Sector within the Government Coordination Council (GCC). Within GCC, HHS and USDA serve as co-leads for the food sector. The GCC is charged with coordinating agriculture and food defense strategies, activities, and communication across government and between the government and private-sector partners.

The Food and Agriculture Sector is a public-private partnership that combines expertise from several federal agencies (FDA, USDA, EPA, Department of Defense (DoD), Department of Commerce, Department of the Interior, and the Department of Justice), as well as that of state, local, tribal, and territorial officials (representing agriculture, public health, and veterinary services), and the private sector (more than 100 trade associations and individual firms participate). GCC members are currently developing a three-to-five year strategic plan, an education package for new members, and a strategic roadmap to help GCC meet the needs of private sector owners and operators and maintain the security and safety of the nation’s food supply.
From 2005 to 2008, FDA was part of a joint federal initiative, along with USDA, DHS, and the FBI, called the Strategic Partnership Program on Agroterrorism (SPPA).
Thirty-six vulnerability assessments were conducted under the SPPA initiative in direct support of HSPD-9. As required by HSPD-9, these assessments are re-evaluated every two years.
FDA has used the CARVER+Shock method to perform vulnerability assessments to identify what an individual or group—intent on doing damage to the food and agriculture sector—could potentially do based on the person’s or group’s capability, intent, and past history. The CARVER+Shock methodology was modified under Homeland Security Council leadership for use in the food and agriculture sector by FDA, USDA, and DoD, with coordination by DHS, CIA, and FBI. FDA’s approach has been to seek voluntary, mutually beneficial partnerships with various segments of the food industry.
FDA Food Safety Modernization Act

On January 4, 2011, President Obama signed into law FSMA.

Contact Us
Food and Drug Administration
5100 Paint Branch Pkwy
Wiley Building, HFS-009
Attn: FSMA Outreach
College Park, MD 20740
6.2 Q: [Added December 2012] When can FDA suspend the registration of a facility registered under section 415 of the FD&C Act?
A: FDA can order suspension of a food facility’s registration when:
1. FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals (SAHCODHA); and
2. That facility:
a. Created, caused, or was otherwise responsible for that reasonable probability of SAHCODHA; or
b. Knew of, or had reason to know of, the reasonable probability of SAHCODHA, and packed, received, or held such food (section 415(b) of the FD&C Act).
C. Who is Exempt from Registration?
9. Farms:
9.1 Q: Is an establishment that manufactures/processes and sells seed to farmers a facility that is required to be registered if the seed is intended to be used as animal food? What if the seed is for cultivation?
A: FDA requires registration of any facility that manufactures/processes, packs, or holds food for consumption in the U.S. “Food” is defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)) to include articles used for food or drink for man or other animals. The establishment that manufactures/processes and sells seed to farmers is a facility that must be registered if the owner, operator, or agent in charge of the establishment reasonably believes that the seed is reasonably expected to be directed to a food use, including animal food use or as an ingredient in animal food. However, if the seed is reasonably expected only to be cultivated, the establishment is not required to be registered. (See Comment 62 in the preamble to the Interim Final Rule).
9.3 Q: If a farm located in a foreign country ships food directly to the U.S., is it required to register?
A: No. A “farm” located in a foreign country that ships food directly to the U.S. is exempt from the registration requirements of section 415 of the FD&C Act ((21 U.S.C. 350d; 21 CFR 1.227(b)(3)). However, if prior to shipping to the U.S., the “farm” ships the food to a foreign facility that manufactures/processes, packs, or holds the food, the second facility must register unless the food subsequently undergoes further manufacturing/processing of more than a de minimis nature at another foreign facility (21 CFR 1.226(a)). The de minimis provision (21 CFR 1.226) is discussed further in Questions 18.1 and 18.2 in this guidance and in the preamble to the Interim Final Rule (Comments 17, 21, 25, and 26).
9.16 Q: If a farm grows hay and sells the hay as feed to a dairy farm that is not under the same ownership, does the hay farm need to be registered? Does the dairy farm need to be registered?
A: As described in the question, both facilities are “farms,” as defined in 21 CFR 1.227(b)(3). Thus, they are not required to be registered.
17.3 Q: If finished food products for consumption in the U.S. are held at a third party facility before consolidation for import into the U.S., must this facility be registered?
A: Yes, if finished products are held at a third party facility for import into the U.S., the facility is required to be registered (21 CFR 1.225 and 1.227(b)).
Food Safety and Consumer Confidence in the Global Food System
China International Food Safety and Quality Conference and Expo
Shanghai, China
November 7, 2012
As prepared for delivery by
Michael R. Taylor
Deputy Commissioner for Foods and Veterinary Medicine
U.S. Food and Drug Administration
Governments worldwide are also working to meet consumer expectations for food safety and to strengthen public confidence. In the United States, consumers and the food industry came together to support passage last year of the FDA Food Safety Modernization Act. China is working to implement the comprehensive food safety modernization law it adopted in 2009. India is implementing the Food Safety and Standards Act of 2006, and Europe has been working for over a decade to strengthen its food safety policies and institutions.
Other countries are pursuing similar food safety initiatives. The Canadian Senate recently passed the Safe Food for Canadians Act to strengthen food safety oversight, and, just to underscore the global sweep of the food safety modernization movement, the Dominican Republic, Madagascar, and Vietnam, to name a few, are pursuing modernized food safety laws, driven by the same public health, consumer confidence and economic goals that motivate food safety modernization in the United States and China.
These include setting the standards that define acceptable levels of food safety performance and create a level playing field for industry; conducting the inspections and investigations that bring objectivity and accountability to the verification that standards are being met and that food safety problems are being solved; and, finally, building the international partnerships that are essential to food safety in a globalized food system.
FDA Food Safety Modernization Act
These themes of food safety and consumer confidence have relevance all across the globe as we work together to modernize food safety systems, and I am pleased that they are deeply embedded in the modernization mandate under which we are working in the United States, namely the FDA Food Safety Modernization Act that was enacted in 2011.
Our new food safety law is grounded in the primary responsibility and capacity of the food industry to produce safe food by implementing modern preventive controls, tailored to the hazards inherent in their operations and to what works most effectively and efficiently to minimize those hazards.
It directs the food industry and FDA to take a comprehensive, systems approach to preventing food safety problems, including a clear mandate for firms to manage their supply chains and for FDA to set modern standards across the farm to table spectrum and build a new import oversight system.
The new law strengthens the public health effectiveness of FDA’s regulatory role, with new inspection and enforcement tools that will shift FDA’s focus from after-the-fact enforcement to real time prevention when firms are not properly implementing modern preventive controls. The Food Safety Modernization Act also emphasizes the importance of FDA’s scientific foundation, including a directive to identify the most significant foodborne hazards and devise science- and risk-based strategies to reduce them.
Under the new rules set to take effect importers must use a foreign supplier verification program (FSVP) to ensure imported food is not adulterated or misbranded and is produced in accordance with FSMA’s hazard analysis and risk-based preventive controls or standards for produce safety, as applicable. This rule takes effect in the new year and will be fully developed over the next two years. Although it is a work in progress companies must begin complying in the new year.
Managerial Flexibility Critical to Risk-Based Controls
The FSMA focuses on prevention of food contamination as the first line of defense against food safety hazards. The Act requires that virtually all food processors, manufacturers, and packers analyze hazards and adopt risk-based preventive controls to manage product safety. Prior to the Act, such preventive controls were only required for juice, seafood, meat, and poultry under Hazard Analysis and Critical Control Points (HACCP) regulations, though many other firms follow its principles in their operations.
HACCP is a quality management system that looks at the operation as a whole. In an HACCP plan, firms must identify potential food safety hazards and where they might arise in their operation. Firms then must develop plans for monitoring these “critical control points” and responding if hazards are detected. HACCP plans also require a recordkeeping system to assist firms and inspectors in verifying that the system is under control. FDA is in the process of defining what will be required under the FSMA.
USDA’s Food Safety and Inspection Service (FSIS) issued one of the first U.S. HACCP rules in 1996.
Traceability Systems Need To Vary by Product
For recalls to be effective, firms need to be able to trace product distribution. Traceability systems are also crucial to speedy identification of the source of contamination in CDC outbreak investigations. The FSMA directs FDA to establish pilot programs to evaluate alternative methods of tracing at least three different types of foods. Based on knowledge gained from these pilot programs, FDA will develop rules to improve product tracing systems for most of the U.S. food supply, building on and enhancing existing systems.
In 2004, ERS researchers studied traceability systems for U.S. produce, cattle/beef, and grain and oilseeds. They found the diverse characteristics of the three commodities–the perishability of produce; the need to prevent theft and credibly assert livestock breeding lineage; and the ability to blend, grade, and store grain–led to the development of very different traceability systems in the three sectors.
The Food and Drug Administration
FDA has the primary role in ensuring the nation’s food supply is safe. Through its regulatory authority and extensive contracts with state and local food and health officials, FDA is responsible for food safety in this country, with the exception of meat, poultry and egg safety requirements handled by the U.S. Department of Agriculture (USDA)


FSIS Food Defense:
Food Safety Modernization Act Considerations
Kim Green
Director, Food Defense Assessment Staff
Office of Data Integration and Food Protection
Food Safety and Inspection Service
United States Department of Agriculture (USDA)
March 3, 2011


About vickysecho

I am desparately trying to find Suzy and Echo that were stolen by deception from me on April 15th, 2012......
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One Response to FSMA Notes…..

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