Welcome to the Coleman & Horowitt, LLP Agricultural and Environmental Law Blog. In this blog, we will focus on developments in California Agricultural and Environmental Law.

Nothing in this blog should be construed as legal advice. ch-law.com is a public website, so communications are not privileged. Copyright Coleman & Horowitt, LLP Attorneys at Law (CH Law © 2017. All rights reserved.)

Thursday, April 13, 2017

 Food Safety Concerns Top Ten for 2017


Posted by Lee N. Smith


These are the Top Ten Food Safety Concerns for 2017 that were identified by the Acheson Group:

  1. Trump's New Administration:What changes will occur  What will the new administration do with the FDA budget and how will that impact its FSMA enforcement resources? It will also be interesting to see if any change is made in the overall direction and function required of FDA – particularly as there is now a food industry representative in the upper echelons, with the appointment of Hardee's/Carl's Jr. CEO Andrew Puzder as Labor Secretary. We don’t expect any dramatic and sudden changes with either FDA or FSIS, but over time there may be a change in enforcement strategy.
  2. FDA Inspections: We can expect to see FDA inspectors facing a continued learning curve as they begin inspections of FDA regulated facilities against the new FSMA regulations. That said, we would expect the number of large facilities inspected to increase over the course of the year. So, while all food facilities should be prepared for an unannounced FDA visit, large companies should be particularly prepared with their food safety plans in place and know that FDA could stop by at any time. So be ready to answer that question from FDA: “Show me your food safety plan.”
  3. Focus on Environmental Controls and Increased Recalls: With FDA inspectors inspecting facilities to FSMA rules and conducting environmental sampling/swabbing and use of PulseNet, they are likely to discover issues that will bring food safety into question. This could be due to any number of reasons, such as incomplete records, questionable environmental monitoring programs, failure to administer proper preventive controls, inadequate training, failure to follow GMPs, etc. As these issues are uncovered, FDA may request specific time frames for manufactured food to be recalled out of an abundance of caution. With the pressure of FSMA and compliance, it is also likely that voluntary recalls will increase, with companies pushing hard to be better educated on risks within their facilities and more. Facilities that are diligent and proactive will be able to detect and correct issues – before a third-party auditor or surprise FDA inspection finds (and cites) them. A key message for 2017 is to make sure you have done the best you can with your environmental control program, especially if you make ready-to-eat foods.
  4. Second Round of Compliance: With the next round of extended compliance dates now coming due, small companies and pet food manufacturers will have to be FSMA-compliant in 2017. These two sectors will be ramping up their food safety plans just as the large companies did in 2016, so we can expect to see a mirror effect as they implement their food safety plans.
  5. Dedicated PCQI Positions: As companies develop and implement their food safety plans, they are becoming very aware of the numerous duties and responsibilities of the Preventive Controls Qualified Individual. With these added responsibilities potentially requiring full-time or contract personnel, depending on the size of the food company and/or complexity of the manufacture of the food product, companies will need to be taking this into consideration and potentially making additional hires or reassessing existing roles.
  6. More Pressure on Suppliers: Food manufacturers and processors depend on suppliers to provide safe ingredients both to ensure the end safety of their products and to fulfill FSMA rules. Thus, suppliers will be scrutinized for complete, thorough and accurate information, followed by increased verification by the food companies. Third-party verification will increase, and the qualifications of the third party will be further scrutinized.
  7. A Continued Request for Clarification: As more food industries become compliant with FSMA, the number of questions submitted to the FSMA Technical Assistance Network (TAN) will continue. Industry trade groups will continue to solicit information and clarification from FDA on specific interpretations of FSMA and how it applies to their niche, and will look for continued guidance updates.
  8. GMO Foods: Beyond FSMA, we can expect to see a continued focus on the regulation/labeling of GMO foods. Although USDA has two years to develop the program, consumers are unlikely to let the matter drop completely, particularly as the drive for natural and "free-from" foods grows and consumers make their voices are heard.
  9. Social Media: We fully expect social media will continue to play a role in numerous ways – and likely in an area that hasn't yet been addressed, though we'd need a crystal ball to be able to say just what that might be. But as more and more people become actively engage in social media, the spread of information -- and misinformation -- will only increase in volume and speed, so food companies will need to be prepared to react properly and efficiently and continue to develop ways to figure out what social media is saying about your brand before it becomes a crisis.
  10. Changing World Views: As 2016 came to an end and the Trump Administration began putting forward its plans, a push and pull of globalization vs. economic nationalism began to show its face. And this is just one of the ways in which the world seems to be unsettled in ways that we've not seen before. It is much bigger than food, but is highly likely to impact the food industry in some way – or many.

Wednesday, April 12, 2017

Prop 65 Listing for Roundup

By Lee N. Smith
 OEHHA has proposed that glyphosate be listed with a No Significant Risk Level (NSRL) of 1100 micrograms per day. For chemicals assessed under Prop 65 for cancer sets a threshold  risk level which represents no significant risk shall be one which is calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question.

This glyphosfate value was based on the results of the most sensitive scientific study to be deemed by the agency to be of sufficient quality.  The effective date of this listing has not been determined pending the resolution of litigation with Monsanto regarding OEHHA’s use of the IARC findings.

The deadline for filing comments with OEHHA regarding this listing is May 22. 

California progressed in its effort to list Monsanto’s  herbicide a carcinogen, after a judge in Fresno ruled finally in mid-March that the state could rely on international standards in its effort require cancer warnings on Roundup.

“The Labor Code listing mechanism does not constitute an unconstitutional delegation of authority to an outside agency, since the voters and the Legislature have established the basic legislative scheme and made the fundamental policy decision with regard to listing possible carcinogens under Proposition 65, and then allowed the IARC to make the highly technical fact-finding decisions with regard to which specific chemicals would be added to the list,” Fresno Superior Court Judge Kristi Kapetan wrote.
The IARC refers to the International Agency for Research on Cancer, a division of the World Health Organization. The agency listed glyphosate – the main ingredient in Roundup – as a “probable carcinogen to humans” in March 2015.
The listing prompted California’s Office of Environmental Health Hazards to file a notice of intent to list the chemical as a possible carcinogen as required by Proposition 65, passed by voters in 1986.
After office filed the notice in September 2015 Monsanto quickly sued, claiming the reliance on the IARC guidelines was unconstitutional.Monsanto maintains glyphosate is safe.






AMERICAN CHEMISTRY COUNCIL CAMPAIGN AGAINST IARC

By. Lee N. Smith

       The American Chemistry Council has launched a public campaign  to change how the International Agency for Research on Cancer-IARC makes decisions about the carcinogenicity of chemicals.This issignificant in California for among other reasons it impacts Prop 65 listings.
        ACC launched the campaign Jan. 25, 2107 said IARC’s decision-making on the cancer-causing potential of chemicals “suffers from persistent scientific and process deficiencies that result in public confusion and misinformed policy-making.” “Public policy must be based on a transparent, thorough assessment of the best available science,” said Cal Dooley, president and CEO of Washington-based ACC, in a statement. “Currently, IARC’s monographs do not meet this standard though U.S. taxpayers foot the bill for over two-thirds of the international program’s budget.”
ACC,  said IARC’s decisions do not use realistic exposure scenarios when informing the public. ACC website that was launched can be found here http://campaignforaccuracyinpublichealthresearch.com/
Recent issues regarding IARC concern coffee and roundup which is the subject of other suits, 
At one point  (IARC) warned coffee drinkers that coffee might cause cancer. However, IARC revisited its decision and downgrading it from “possibly carcinogenic” to “not classifiable.” 
 The latest dispute  concerns glyphosate, an ingredient in a widely-used weed killers, Roundup, made by Monsanto.In March 2015, an IARC monograph concluded that glyphosate is “probably carcinogenic.” Yet seven months later the European Food Safety Authority (EFSA), an independent agency funded by the EU, published a different assessment, saying glyphosate is “unlikely to pose a carcinogenic hazard to humans.” 

Tuesday, April 11, 2017

Telone Lawsuit Filed


by. Lee N.Smith

Attorneys representing a Ventura County farmworker and environmental justice groups filed a lawsuit against the California Department of Pesticide Regulation (DPR) in January 2017 alleging that the California state agency did not do enough to protect the public from the fumigant pesticide Telone (1,3-dichloropropene).  The lawsuit, filed in Alameda County Superior Court, alleges that DPR failed to follow the recommendations of scientists, and failed to provide public review for the regulation of the chemical. also known as   Specifically, the lawsuit first charges that DPR did not follow normal public procedures in developing new rules for Telone. This includes giving public notice and allowing the public an opportunity to comment.  The suit also alleges that DPR did not base its regulations on the advice of scientists at the Office of Environmental Health Hazard Assessment (OEHHA), and is in violation of a state law that requires the agencies to work together in crafting regulations, said Mark Weller, a spokesman for Californians for Pesticide Reform.  Banned for agricultural use in the European Union since 2011, as well as in California between 1990 and 1995, Telone is the third most used pesticide in California by pounds and the second most used “pesticide of public health concern” near public schools.  Telone is injected into the soil to kill pests before planting. Pesticide opponents say it drifts for days after and miles away from its application. 

Monday, March 27, 2017

New Greenhouse Gas Legislation Affecting Agriculture SB 32, AB 197 SB 1383

By Lee N. Smith & Craig A. Tristao
The new Greenhouse gas legislation “package” extends California’s  Gas Cap & Trade program and sets   new emission  reduction goals for 2030. It further sets emission reductions for methane.  The legislation has the potential to impact dairies, landfills and composting operations. The attached powerpoint which was originally presented at the  Manufacturers’ Council of the Central Valley September meeting, provides a review of California legislation regarding climate change law (SB32, AB 197 and SB 1383) together with an explanation of what it means to the Dairy Industry.  2016-09-21-mccv-presentation-sb-32-ab-197-cat-and-lns

New Prop 65 Regulations have Been Approved

In August 2016 OEHHA finalized the new Prop 65 Warning regulations.
  • In summary, there is new safe harbor language, a new website for consumers, and attempts to clarify liability as between manufacturers and retailers. The new regulations go into effect on August 30, 2018, new labels can however be used before that time. The language required by Consent Judgments is considered within safe harbor. The new labels contain language that requires the identification of at least one of the Proposition 65 chemicals in the product.The language for each of the types of warnings (i.e. environmental vs. product) has changed.
  • The emphasis is for liability to the manufacturer; along with additional duties toward vendors.
  • There is new web Proposition 65 site sponsored by OEHHA.
  • There are new symbols required on the safe harbor labels.
  • Manufacturer/Retail Seller Responsibilities
    • Product manufacturers have primary responsibility for warning.
    • Manufacturer can label product or provide notice to distributor/importer/retail seller that a product may cause an exposure to a listed chemical.
    • Provide warning signs, materials (unless they make other arrangements via contract).
      • Retail sellers confirm receipt of notice act as “pass-through” for warning.
    • Provide non-English language warnings in certain situations.
    • Safe Harbor Content and Methods
  • “This product contains….”
    • “This product can expose you to….”
    • The name of at least one chemical in the warning.
    • Warning required for chemicals A and B.  Business can include the name of A or B, or both.
    • Named chemicals are those for which warning is being provided.
    • Business selects which chemical(s) to include in warning.
    • Answers question: “What am I being exposed to?”
    • OEHHA web site URL
    • Warning symbol
  • Phase In:
  • Two-year phase-in period.
  • Effective date of regulation: August 30, 2018.
  • Consumer products manufactured prior to the effective date will not require new warnings if they meet existing safe harbor requirements.
  • Court-approved warnings expressly recognized and considered “clear and reasonable” for parties to litigation.
  • Tailored Warnings; in addition to the specific warnings listed above, the code has modified the warnings for the following categories:
  • Environmental Exposure
  • Occupational Exposure
  • Specific Product, Chemical and Area Exposure Warnings
  • Food
  • Alcoholic Beverages
  • Food and Non-Alcoholic Beverages
  • Prescription Drug Exposure and Emergency Medical or Dental Care Exposure
  • Dental Care
  • Raw Wood Products
  • Furniture Products
  • Diesel Engines
  • Vehicles
  • Recreational Vessels
  • Enclosed Parking Facilities
  • Amusement Parks
  • Petroleum Products
  • Service Station and Vehicle Repair
  • Designated Smoking Areas

Prop 65 Rules Finalized ? Current Revisions

Oeeha has revised the new notice regulations requesting comments by June 6, 2016.
following is quoted from the Oehha site.
The The most significant changes are summarized below:
  • In Section 25600(e) the term “fully” was removed.  This provision is intended to be a statement of current law.  Specifically, if a party to a court-ordered settlement or judgement complies with the order requiring a particular method or content for a warning, the warnings provided are clear and reasonable as a matter of law.  Commenters asked that OEHHA clarify its intent that this provision is not intended to provide a new avenue for enforcement of the law through this provision.
  • Section 25600(f) was moved from Section 25601(b) and slightly modified to clarify that businesses are free to provide a warning that is different from the safe harbor methods and content specified in Subarticle 2 as long as the warning complies with Section 25249.6 of the Act.
  • Section 25600.1(c) was revised by removing the phrase, “but is not limited to” and adding the words, “company name, location of manufacture” as additional exceptions to the definition of “consumer information”.
  • In Section 25600.1(e) the word “consumer” was added to clarify the type of product intended to be included.
  • In response to several comments, section 25600.1(f) was revised to delete the words “medium, including but not limited to”, add the term “source, such as”, and add the phrase “or objects”, to better clarify the sources of exposure that should be identified in an environmental exposure warning.
  • In Section 25600.2(a) the phrase, “to the extent practicable” was added to parallel the statutory requirement concerning adopting regulations concerning clear and reasonable warnings.
  • Section 25601(b) (formerly numbered as subsection (c)) was revised to remove, “for which the person has determined a warning is required” and replaced with, “in the consumer product or affected area for which the warning is being provided” to clarify that the regulation does not impose any new testing or burden of proof requirements for a business.  This regulation only applies where a business has already decided to provide a warning; it does not determine when a warning is required.
  • Sections 25602(d) and 25607.1(c) were revised to better clarify the circumstances under which a warning must be provided in a language other than English.
  • Based on several comments, clarifying changes were made for consistency throughout the regulation to terms that were being used inconsistently including “label”, “warning labels”, “warning materials” and “warning information”.
  • The uniform resource locators (URLs) for the general warning content were shortened to “WWW.P65Warnings.ca.gov” for simplicity and consistency with the existing structure of the warnings website.
  • In Section 25603(a)(2) and throughout the regulations the term, “such as” was replaced with “including” for the warning content in response to comments suggesting the word is more clear.
  • Section 25603(a)(2)(E) was added to allow a business to provide a consumer product warning for a single chemical exposure, by allowing the business to delete the words “chemicals including” from the safe harbor warning content.
  • Section 25604(a) was revised to ensure consistency in the format, structure and requirements for environmental warnings.
  • Section 25605(a) was revised for readability and clarity.  An example of the text of a compliant warning is as follows:
WARNING: Entering this area can expose you to chemicals known to the State of California to cause cancer, including asbestos, from construction debris. For more information go to www.P65Warnings.ca.gov(link is external).
  • Section 25605(a) was modified to allow a business to provide an environmental warning for a single chemical exposure.
  • Section 25606(b) was added to clarify that occupational exposure warnings for chemicals that are not covered under subsection (a) can be provided using the methods and content requirements set out in the regulations for consumer product or environmental exposures.
  • Section 25607.2(a)(4) was revised for consistency with the other consumer product warnings.
  • Section 25607.2(a)(6) was added to allow a business to provide a food product  warning for a single chemical exposure, by allowing the business to delete the words “chemicals including” from the safe harbor warning content.
  • Section 25607.23(a)(3) the warning content for the amusement park tailored warning was revised to replace “[Name of one or more exposure source(s)]” with “Some areas or features” in consideration of the unique characteristics of environmental exposure scenarios in amusement parks.  OEHHA intends to develop more information for its website concerning the most common sources of exposures, the chemicals that are likely to be present at amusement parks, and ways patrons can reduce or avoid exposures in order to supplement this warning, just as OEHHA plans to provide more detailed website information for all of the tailored warnings.