8:30 am - 2:30 pm

650 Capitol Mall, Sacramento, CA 95814

Note: A valid State or Federal ID is required for entry to the John E. Moss Federal Building.

The purpose of this public meeting is to discuss the proposed rule to establish current good manufacturing practice and to require hazard analysis and risk based preventive controls for food for animals. This proposed rule is one of several proposed rules that will establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The meeting is also designed to solicit oral stakeholder and public comments on the proposed rules, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules.

This is the third of three public meetings FDA plans to hold on this FSMA proposed rule. Information on the additional meetings can be found on the FSMA Meeting page. The agenda format will be the same for each meeting.

For general questions about the meeting, for assistance to register for the meeting, to request an opportunity to make an oral presentation, or to request special accommodations due to a disability, contact: Aleta Sindelar, 7519 Standish Place, RM 133, Rockville, MD 20855; Phone 240-276-9230; Fax 240-276-9241; or Email aleta.sindelar@fda.hhs.gov.

Register Online

You may register online by completing the electronic registration form and emailing it. See the instructions below.  

• Click on electronic registration form; a registration form will open
• Complete the form
• Click Submit at the bottom of the form; an email with the form as an attachment will be generated
• A pop-up window will open asking you to select an email client; if the pop-up window does not appear, make sure that your browser is set to allow pop-ups
• Select your Desktop Email (or Internet) Client, and click OK
  • If you chose Desktop Email Application, an email will pop-up
  • Click the Send button on the email to submit the form
    NOTE: hitting Submit on the form alone does not send your registration; you must email the form to complete the process
• To print or review your submitted registration form, check the email folder which stores your Sent emails

Registration for the meeting will also be available on site. 

This meeting will be available for public viewing via Adobe Connect at

https://collaboration.fda.gov/dec_6_fda_fsma_public_meeting/  

at the time of the meeting.

• Click here for more....

Farm Bill Conference Nearing Crunch Time; Spending Caps Needed

Governor Brown this week announced the appointments of David Lanier as Secretary of the California Labor and Workforce Development Agency and Marty Morgenstern as Senior Advisor in the Office of the Governor.  Lanier replaces Morgenstern, who has served as secretary since 2011. While Morgenstern is retiring, he will continue to serve the Governor as a senior advisor without compensation.

Lanier, 46, of Davis, the new Secretary of the California Labor and Workforce Development Agency, has served as chief deputy legislative affairs secretary since 2011. He served as special advisor to the Speaker at the California State Assembly Speaker's Office of Member Services from 1999 to 2011. Lanier was chief of staff for California State Assemblymember Grace Napolitano from 1997 to 1998.

Morgenstern, 78, of Oakland, now a Senior Advisor in the Office of the Governor, has served as Secretary of the California Labor and Workforce Development Agency since 2011. Morgenstern was a consultant for the University of California on labor relations matters from 2003 to 2011 and director of the California Department of Personnel Administration from 1999 to 2003 and from 1981 to 1982. Morgenstern was a consultant in private practice from 1994 to 1999.

The national food industry spent an estimated $22 million to successfully defeat this week a Washington State ballot initiative that would have required all foods - including animal feeds and pet foods - sold in the state to be labeled if made from or with genetically modified (GM) ingredients. The margin of victory was 54-46% against the ballot question. Pro-labeling groups spent an estimated $8-10 million.  The county in which Seattle sits voted nearly 57-43% in favor of the initiative.

The Grocery Manufacturers Assn. (GMA) in Washington, DC, coordinated much of the fundraising and boots-on-the-ground opposition to the labeling initiative, running afoul at one point of Washington State political registration and campaign financing laws.  GMA was forced to file the names of its member companies paying into a special account to battle state initiatives.   

"We are pleased the voters of Washington State rejected (the ballot initiative) by a significant margin," said Pam Bailey, GMA president. "(It) was a complex and costly proposal that would have misled consumers, raised the price of groceries for Washington families and done nothing to improve food safety."

Reports indicate at least 20 state legislatures will take up some form of GM labeling legislation in 2014.  This continuing push by pro-labeling groups signals national food companies will very likely turn to Congress to preempt the states on food labeling while requiring FDA to clarify and expand its labeling policies.   

This is the second state-wide GM labeling ballot initiative to be defeated.  California voters rejected a similar ballot question in 2012, a battle food companies spent an estimated $45 million to win.

Maine and Connecticut legislatures passed GM labeling laws, but those laws require at least five neighboring states to pass similar laws. The Connecticut law requires at least one state to share its border.  The Connecticut law is expected to be "clarified" in January that it does not apply to animal feeds and pet foods sold in the state.

USDA this week announced actions to deregulate several pending biotech plant varieties, while in separate action asked the public to comment on how "coexistence" between biotech plantings and non-biotech plantings can be achieved.

The Animal & Plant Health Inspection Service (APHIS) published a notice to deregulate a Monsanto soybean variety designed to increase yield.  The agency also published a request for public comment on the draft environmental assessment (EA) and draft plant pest risk assessment (PPRA) in response to a petition from BASF to deregulate its herbicide resistant soybean variety.  It also published for comment on the same two assessments on a petition on apples designed to resist browning developed by Okanagan Specialty Fruits, Inc.

On coexistence, the Advisory Committee on Biotechnology & 21st Century Agriculture (AC21) is asking for comments on how to achieve coexistence following up on its 2012 report "Enhancing Coexistence: A Report of the AC21 to Secretary of Agriculture."  The report recommended action in five areas:  Potential compensation mechanisms in cases of contamination; stewardship; education and outreach; research, and seed quality.  After the comment period, USDA intends to hold a public meeting to discuss the public input.  The comment period ends January 3, 2014.  The documents can be found at www.usda.gov at the AC21 page.

Taking steps to implement President Obama's executive order this week creating an administration-wide "Task Force on Climate Preparedness & Resilience," EPA released its draft Climate Change Adaptation Implementation Plan for public comment. The comment period ends January 3, 2014.

The full draft plan, as well as other climate change-related documents, can be viewed by going to www.epa.gov, and following the icons to the climate change section.

The President's task force includes not only federal officials, but state, local and tribal leaders, included for their experience in handling natural disasters.  

Meanwhile, Sen. David Vitter (R, LA), ranking member of the Senate Committee on the Environment & Public Works, led a group of four Senators in writing to EPA Administrator Gina McCarthy wanting to know what EPA knows about the "Administration's lobbying efforts to skew the results" of the upcoming multi-nation Intergovernmental Panel on Climate Change (IPCC) report.  In a press release, Vitter said the U.S. government "weighed in" and requested "alterations to the scientific analysis," calling the IPCC process "not a purely scientific one."

The four Senators want to know if McCarthy was aware the IPCC report "was not going to support the statements of President Obama when she testified in April that the IPCC would, in fact, be able to do so."  Earlier this year, AP reported multiple countries lobbied the IPCC to swing the report conclusions one way or the other.

The EPA plan, which will be followed by similar plans from other Administration departments and agencies, is designed to provide information on how the agency will help the nation "adapt to a changing climate."  

EPA said the implementation plans offer "a roadmap" for agency work to protect public health and the environment.  These include plans to deal with extreme weather, floods and droughts, the agency said.  A separate draft - the "Climate Change Adaptation Plan" - was released in February, and is expected to be finalized sometime this fall.  

A new proposed rule released this week by OSHA would require all employers to submit required workplace injury and illness records electronically, the agency saying electronic submissions will allow it to better target workplace safety actions.

OSHA says the new rule will allow it to improve workplace safety and improve tracking of injuries and illnesses, and timed the new rule to follow the release of the annual Bureau of Labor Statistics (BLS) report that shows 3 million workers were injured on the job in 2012.

The rulemaking is the result of a series of stakeholder meetings held in 2010 specific to electronic reporting.  The new rule will require electronic reporting of injury and illness reports, but will not change the data to be collected under existing standards.  The agency said it intends to eventually post the data online "as encouraged by President Obama's Open Government Initiative."

The comment period on the new rule ends February 6, 2014, and the agency plans a public meeting in Washington, DC, for January 9.  The rule can be found by going to www.osha.gov.

The full House this week approved legislation protecting farmers who seek to use pesticides "on or near" navigable waters from the burden of having to register and permit the approved chemicals twice.  This is the second time in as many congresses the House has approved the permit fix; the Senate Agriculture Committee approved a similar solution to the permit problem.

Under the bill, a chemical can be used on or near navigable waters if it's already approved under FIFRA.  This was the case until 2011 when EPA declared "point-source emitters," including vehicles used to spray pesticides, had to get a National Pollutant Discharge Elimination System (NPDES) permits on top of the FIFRA registration.  

While the House version of the Farm Bill contains similar language, it's expected that once the House bill is sent to the Senate, Sen. Benjamin Cardin (D, MD) will again block it as he has successfully done over time.

Water Bill Moving to Conference as Senate Names Conferees

Thousands of small businesses around the U.S. are racing to renew their health insurance policies Dec. 1 to beat large premium increases their brokers say will hit them Jan. 1 when the Affordable Care Act takes full effect.

Some health insurance brokers also say 2014 may be the last year many of the companies even offer health insurance.

Insurance brokers from several states told USA TODAY that 60% to 80% of their small-business clients - those with 50 employees or fewer - are renewing their policies early to skirt the law. Companies with more than 50 employees aren't allowed to adjust their renewal dates.

Many companies are still waiting to hear what rates they'll be facing in 2014, as state insurance commissioners are backlogged with tasks related to ACA compliance.

• Read Full Article...

Benefits Done Right Insurance Agency Blogs

• PPACA Taxes and Fees: How We Are Managing the Chaos 

• The Unintentional Consequences of Obamacare