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Download: Press Release.General.pdf

Click link to view press release.

The USDA has issued a new “strategy” document that outlines the agency’s direction with regard to implementing the Food Safety Modernization Act (“FSMA”).  The document is intended to “to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change.” The strategy includes agency internal changes as well as purporting to be a guide to the rules regarding food and feed facilities, produce safety and the new food import system.

The Appendix of the strategy contains the FDA Guiding Principles which are mostly set out below:

Inspection and Surveillance 

FDA will significantly expand its inspection and surveillance tools to include a wider range of inspection, sampling, testing, and other data collection activities conducted through its own field force and through collaboration with partner agencies and the food industry.

• Efficiently screening firms for food safety performance to guide risk-based inspection priority, frequency, depth, and approach
• Providing firms incentives for compliance through enhanced presence in and targeted scrutiny of high-risk firms and products and reduced scrutiny of firms with records of demonstrated good performance
• Assessing the compliance of individual firms through a range of inspection and sampling techniques used in a strategic, risk-based way to maximize coverage of priority sectors and firms
• Making in-depth assessments of individual firms when needed to increase the incentive for compliance and determine the need for compliance or enforcement actions
• Collecting data to inform understanding and analysis of sector-wide hazards, practices, and preventive control deficiencies
• Collecting data on compliance rates to evaluate program performance and plan future efforts

Administrative Compliance Tools 

FSMA’s public health prevention focus and new administrative enforcement tools mean that FDA’s primary tools for correcting preventive control deficiencies and resolving problems that put consumers at risk will be administrative compliance actions, rather than court enforcement cases, including:

• Voluntary correction of problems at the facility level, achieved immediately during the course of an inspection through communication with firm management by investigators and, as needed, Center technical staff
• Voluntary correction achieved at the District level through deficiency letters, issued within days after an inspection with Center back up, to document significant safety-related deficiencies and request correction within a specified period, with immediate inspection follow up to verify correction
• Administrative detention of product if needed to provide immediate public health protection or for other appropriate purposes.
• Voluntary and mandatory recalls to remove potentially hazardous food from the market
• Administrative suspension of registration when other administrative compliance measures have failed or are inadequate to achieve correction of significant deficiencies that put consumers at risk

Judicial Enforcement Tools  

Guiding Principles for Implementation of Produce Safety Standards

Effective implementation and oversight of produce safety standards poses distinct challenges for FDA due to the scale and diversity of the produce sector, the large number of produce farms, and their lack of familiarity with FDA regulatory oversight. Moreover, Congress envisioned a different role for FDA on produce farms compared to food facilities, as reflected in the lack of an inspection frequency mandate in FSMA for farms, the directive to coordinate education and enforcement activities with state and local officials , and the mandate to USDA to provide technical assistance grants to support implementation, especially for entities such as small growers.

Another reality shaping FDA’s approach to produce safety is that there is no reasonable expectation FDA will have the resources to make routine on-farm inspection a major source of accountability for compliance with produce safety standards.

For this reason, FDA’s implementation of produce safety standards will entail a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.

In keeping with this broad vision for FSMA implementation, FDA will focus its efforts on:        

• Deploying a cadre of produce safety experts in headquarters and the field with the depth and breadth of capacity to develop the guidance needed to support implementation and provide technical support to government and industry parties working to foster compliance
• Actively supporting education and technical assistance for growers, primarily through collaboration with other public and private parties
• Supporting public and private parties involved in audits and other accountability functions with technical assistance and other collaborative support
• Conducting targeted on-farm surveys and inspections to understand current practices and identify gaps in compliance
• Taking administrative compliance and enforcement action when needed to correct problems that put consumers at risk
• Responding to produce outbreaks effectively to lessen impact on public health
• Conducting in-depth environmental assessments where appropriate to identify root causes of outbreaks associated with produce and inform future prevention efforts

Guiding Principles for Implementation of FSMA’s New Import System

FSMA provides FDA with a multi-faceted new tool kit for import oversight that is intended to ensure that imported foods are produced using modern preventive measures that achieve the same level of food safety protection as FSMA’s new preventive control and produce safety standards. FDA will use the new tool kit to build a prevention-oriented import system that provides much-heightened assurances about the safety of imported food.

Rather than relying primarily on FDA detecting and stopping food safety problems at the border, the new system relies primarily on importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems. To complement FDA’s oversight of importers, FSMA directs FDA to strengthen private audit systems, increase its overseas presence, and work in partnership with foreign governments to strengthen and capitalize on their capacity to help ensure the safety of food destined for the United States, all in keeping with the collaboration and leveraging elements of our operational strategy for FSMA implementation.

FDA will use all elements of the FSMA tool kit to provide the heightened assurances of food safety called for by Congress and expected by consumers in a manner that makes efficient use of FDA’s resources and leverages the resources and efforts of others.

Key features of FDA’s import implementation effort will include:

• Developing the skills, capacity, and processes to audit foreign supplier verification programs and hold importers accountable for effectively managing their supply chains in accordance with FSMA
• Reconfiguring current import screening and field exam activities to complement oversight of FSMA’s  foreign supplier verification requirement and ensure that FDA is making strategic, risk-based use of its import oversight resources
• Implementing the voluntary qualified importer program and other measures to expedite entries for good performers and thereby allow more resources to be directed toward high-risk imports
• Developing the skills, capacity, and processes to audit accrediting bodies and accredited third-party certifiers, with the goal of enhancing the rigor, objectivity, and transparency of private audits and their contribution to assuring the safety of imported food
• Developing the skills, capacity, and processes to conduct comparability assessments of foreign government regulatory systems as the basis for relying, where justified, on foreign oversight, minimizing duplication of effort, and improving risk-based resource allocation
• Building data integration and analysis systems and harnessing all available sources of relevant information to strengthen risk-based targeting of resources

Download: Scott Hervey.Variety Legal Impact Report.2014.pdf

Los Angeles, California, April 21, 2014 – Weintraub Tobin Chediak Coleman Grodin Law Corporation congratulates its partner, Scott Hervey on being recognized by Variety in its 2014 Legal Impact Report.

This report, appearing in the April 15 issue of Variety, highlights the nation’s top entertainment industry lawyers whose work has helped shape the film, television, music and digital media industries.

“Scott keeps one foot in Hollywood and the other in Silicon Beach” said Weintraub’s managing partner, Michael Kvarme. “His unique mix of traditional television and technology and digital media clientele earned him this prestigious spot.”

Scott works with tech start-ups, gaming companies, TV production companies, multi-channel online networks, YouTube channels and technology investors. Scott Hervey received his J.D. with distinction, from the University of Pacific, McGeorge School of Law. Scott is a professor of entertainment law at King Hall, U.C. Davis, serves on the Hollywood Radio and Television Society’s Board of Directors and as the chair of the Digital Media section of the Los Angeles Venture Association.

Download: Flyer – Complex Web of Federal, State and Local Leaves of Absence Laws (1739109).PDF

Summary of Program
Employers continue to grapple with this very difficult area of employment law. It is not enough to focus on just one law when an employee is unable to work or is absent from the workplace due to some medical condition or injury suffered by the employee or his or her family member. Instead, employers need to understand and comply with how the courts, and various federal and state regulatory agencies, are interpreting the interplay between a number of laws like the FMLA/CFRA, ADA/FEHA, PDL, USERRA, and workers’ compensation. This seminar is designed to help employers and HR professionals understand this complex interplay and to provide some practical guidance on administering leaves and absences.

Program Highlights

• New Regulations and Agency Directives.
• What Does Each Law Provide: A Summary of the Statutes and Regulations.
• A Discussion of the Difference Between “Statutory Leaves” and “Wage Replacement Benefits.”
• Under What Circumstances the Statutory Leaves and/or Wage Replacement Benefits May Overlap and How to Evaluate and Determine the Employee’s Entitlements and the Employer’s Obligations Under Each Law.
• The Importance of Engaging in the “Interactive Process.”
• What are the Courts saying? Recent case law.
• Effective Documentation: Policies, Leave Administration Documents, and Medical Certifications.

Seminar Program
8:30 a.m. Registration and Breakfast
9:00 a.m. – 12:00 p.m. Seminar

Approved for 3 hours MCLE credit; HRCI credits available upon request. There is no charge for this seminar.

RSVP
Ramona Carrillo
400 Capitol Mall, 11th Fl.
Sacramento, CA 95814
916.558.6046
rcarrillo@weintraub.com

Weintraub Tobin
400 Capitol Mall, 11th Floor
Sacramento, CA 95814

Parking validation provided. Please park in the Wells Fargo parking garage, entrances on 4th and 5th Street.

Download: 012714 Private Placement Press release Final.pdf

RANCHO CORDOVA, Calif., January 27, 2014 — ThermoGenesis Corp. (Nasdaq: KOOL) today announced that it has entered into definitive agreements with institutional investors in connection with a private placement of common stock and warrants to purchase common stock. Upon the closing of this financing, ThermoGenesis will receive gross proceeds of approximately $6.67 million resulting from the issuance and sale of approximately 3.33 million shares of common stock at a price per share of $2.00. The purchasers will also receive warrants to purchase up to approximately 1.66 million shares of common stock at an exercise price of $2.81 per share. The warrants are non-exercisable for six months after the closing of the financing and have a term of 5 years.

To view the full press release click the link above.

Download: WTWB Merger Press Release FINAL.pdf

Weintraub Tobin Chediak Coleman Grodin Law Corporation and Waldron & Bragg, a professional corporation, have jointly announced the merger of their business law and litigation firms. The combined firm will be named Weintraub Tobin Chediak Coleman Grodin and have offices in Sacramento, Calif., San Francisco, Calif., Beverly Hills, Calif., and Newport Beach, Calif. With more than 70 attorneys, the firm will continue to focus on corporate, litigation, entertainment, banking and finance, real estate, labor and employment, intellectual property, tax, trusts and estate planning, fiduciary abuse, and bankruptcy, among other areas.

“Dating back to 2010, our goal has been to grow to a state-wide firm that provides exceptional service to dynamic and growing companies throughout California. In keeping with our strategy, we have been open to growing in our current markets of Sacramento, San Francisco and Beverly Hills as well as looking at new areas that match the needs of our clients.” said Michael Kvarme, Weintraub’s managing shareholder. “Waldron & Bragg has a significant litigation practice and an exceptional reputation for their trial experience that will be an excellent addition to our existing practice. The combination of our firms represents our shared commitment to continually provide the highest quality legal services to our clients.”

“We are very pleased to know that the firm is available to our Plan directors, and members, throughout the entire state of California.” said long-time firm client, Rick Floyd, Plan Administrator for the California Law Enforcement Association, California Association of Professional Firefighters, and National Peace Officers and Firefighter’s Benefit Association. “Weintraub has served the legal needs of California Firefighters and Peace Officers since 1984. The firm’s recent expansion into Orange County will have a very positive impact on our 45,000 participating members state-wide and specifically more than 2,000 firefighters and peace officer members within the area.”

“Our clients have a need for expanded legal expertise in areas that Waldron & Bragg currently does not offer, and Weintraub brings these capabilities to the table with exceptional attorneys.” said Gary Waldron, shareholder at Waldron & Bragg. “Weintraub is unique in that it provides the breadth and depth of services found at larger firms while providing the personal touches and responsiveness of a smaller one. This commitment to clients and service are at the core of each of our firms and will only make us stronger as one firm moving forward.” said Sherry Bragg, managing shareholder at Waldron & Bragg.

The firm’s executive committee will increase to six members as of Jan.1, 2014 and will include Chris Chediak (Sacramento), Gary Bradus (Sacramento), Ed Corey (Sacramento), Paul Gaspari (San Francisco), Marvin Gelfand (Beverly Hills) and Bragg (Newport Beach), with Kvarme continuing to serve as the combined firm’s managing shareholder based out of Sacramento.

With headquarters in the California state capitol and offices in San Francisco, Beverly Hills and Newport Beach, the firm of Weintraub Tobin combines its shared vision and pledges to be an innovative provider of sophisticated legal services to dynamic businesses and business owners, as well as non-profits and individuals with litigation and business needs. The firm continues its long-time and strong support of the communities in which its attorneys live and work.

“We welcome Shinmei U.S.A. to the growing community of food-related companies in the Sacramento region, America’s farm-to-fork capital,” said SACTO Chair Gary Bradus, shareholder with Weintraub Tobin. “We are honored that Shinmei has chosen West Sacramento in which to locate its new U.S. headquarters and production facility.”

Click the link above to read the full press release.

For a third year in a row, Weintraub Tobin is working to raise funds for cardiovascular diseases and stroke by partaking in the American Heart Association Heart Walk on Saturday, September 21 at William Land Park.

Our attorneys and staff work hard during the summer months to gear up for the walk, which raises the dollars needed to fund life-saving research and initiatives in our local community. Each year, the firm thinks of unique and creative ways to solicit donations for the cause – from firm potlucks and bake sales to a vendor fair in the Wells Fargo lobby and an annual pancake breakfast. The firm raised $8,000 in 2011 and $9,500 in 2012, with the hopes of bringing in even more for the cause this year.

Attorney Jim Clarke serves as the firm’s Heart Walk captain.

To join Weintraub Tobin in the fight against cardiovascular diseases and stroke, visit our Heart Walk Homepage.