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.)

Tuesday, June 27, 2017

Glyphosphate the Main Ingredient in Roundup will be Listed on Prop 65 July 7

The State announced that starting July 7 the Roundup's  main ingredient, glyphosate, will be listed on Prop 65.  A year later,  warning labels could be required on the product. Monsanto, the chemical’s maker, has however filed an appeal after losing in court to block the labeling, arguing that Roundup does not the requirements under Prop 65 as a carcinogen.

Sunday, June 25, 2017

Prop 65: Legislature Considers Bill Revising Certificates of Merit

Prop 65: Legislature  Considers Bill Revising Certificates of Merit

The legislature is considering a bill (AB 1583) that would revise the rules governing certificates of merit. Currently anyone alleging a violation of Prop. 65 must complete a certificate of merit showing they have consulted with an appropriate expert who agrees that there is a reasonable and meritorious basis for the action. The party providing the notice  must provide information backing up the certificate of merit to the state Attorney General's office as part of the 60-day notice of violation they must lodge before filing a lawsuit. 

The current law limits the alleged violator's access to information in the certificate of merit to material that "is relevant to the subject matter of the action and not subject to the attorney-client privilege, the attorney work product privilege, or any other legal privilege." An alleged violator may currently only pursue discovery of the basis of the certificate of merit during litigation if the court has undertaken its own review of the certificate

The new Bill would:

1) Require the California Attorney General (AG) to serve a letter to the noticing party and the alleged violator stating that the Attorney General believes there is not merit to the action, if, after reviewing the factual information alleged to establish the basis for the certificate of merit, and meeting and conferring with the noticing party regarding the basis for the certificate of merit, the Attorney General determines there is not merit to the action; and specifies that the Attorney General’s decision not to serve a letter shall not be construed as an endorsement of the action.

 2) Provides that the basis for the certificate of merit is discoverable to  the extent that the information is relevant to the subject matter of the action and not subject to the attorney-client privilege, the attorney work product privilege, or any other legal privilege.

 3) Requires the Governor’s Office of Business and Economic Development to post, in a conspicuous location on its Internet Web site, any informational materials provided to businesses relating to a business’s obligation under state law, as well as a specified disclaimer.

 4) Finds and declares that this bill furthers the purposes of Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. .

The latest version of the bill also adds a requirement that the Governor's Office of Business and Economic Development provide businesses information regarding their obligation to comply with Prop. 65. Hearings are scheduled  in the senate for early July 2017.

Change in Regulations Regarding Notices of Violation

The Office of Environmental Health Hazard Assessment (OEHHA) has proposed two changes in its regulations regarding the contents of the Notices of Violation. The first change is being made to section 25903(b)(2)(E), concerning occupational exposures. Such notices are to contain specific language required by the Occupational Health and Safety Regulations in Title 8, Section 338(b) of the California Code of Regulations; the current version does not cross-reference this section.  

The regulations currently require any Notice of Violation to include a copy of an Appendix A which alerts the target of the notice to the substance of Prop. 65. The option to cure these violations without further liability was added by legislation intended to end the practice of targeting small businesses that are unaware of their potential Prop. 65 liability in order to extract a quick monetary settlement (i.e., drive-by litigation). Instead of placing this compliance procedure with the more general information in Appendix A, OEHHA is proposing to move the language to a new Appendix B. This change is applicable to those situations that are subject to the legislation (a) alcoholic beverages consumed on premises; (b) food or beverages prepared and sold for immediate consumption;  (c) non-employee tobacco smoke on premises where smoking is permitted; or (d) engine exhaust at a facility primarily intended for parking noncommercial vehicles. There are remedial measures that are also required under each scenario.

Hearing on Naturally Occurring Level in Candy Containing Chili/Tamarind

Hearing on "Naturally Occurring" Lead Levels in Candy Containing Chili and Tamarind

The Office of Environmental Health Hazard Assessment (OEHHA) is holding a public hearing in response to a petition from the Center for Environmental Health requesting that OEHHA “commence the regulatory process to issue regulations pursuant to Health & Safety Code §110552 setting a ‘naturally occurring’ lead level in candy containing chili and tamarind.”   the hearing has been rescheduled for July 6, 2017 from 10:00 a.m. to 12:00 p.m. in the Sierra Hearing Room at the CalEPA Headquarters building at 1001 I Street in Sacramento.  The hearing will be webcast at https://video.calepa.ca.gov/(link is external) (not active until the day and time of the hearing).  

Monday, May 29, 2017

Monsanto Alleges that the Roundup Lawsuit is Preempted by Federal Law

Two nonprofit groups in April, 2017 alleged that Monsanto intentionally mislabeled its weed killer Round Up as "target[ing] an enzyme found in plants but not in people or pets." The lawsuit charges that Monsanto's statement is "false, deceptive and misleading" because the enzyme targeted by glyphosate "in fact, is found in people and pets."

Beyond Pesticides and the Organic Consumers Association, through their attorneys filed the lawsuit in Washington, DC, court under the District of Columbia's Consumer Protection Procedures Act. The case is Beyond Pesticides et al v Monsanto Co. et al.  The company's lawyers in turn, allege that since the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) makes the U.S. Environmental Protection Agency responsible for the accuracy of pesticide labeling the case is preempted  based on existing case law in which courts have already held that the law precludes any state labeling requirements different from FIFRA.

In addition  to  this suit there are a number of suits and class actions against Monsanto alleging  that  glyphosate, Roundup’s active ingredient, is carcinogenic and tied to cases of non-Hodgkin lymphoma — an association Monsanto strongly disputes and that is also the topic of competing findings of scientific groups assessing cancer risk.

Adding complications to these cases is the recent Fresno Superior Court case in which the court held that the Prop 65 listing by the state of California, as a carcinogen was proper.  Judge Kapetan  in her ruling against Monsanto,  allows California to proceed with the process of listing glyphosate, the active ingredient in Roundup, as a chemical "known to the state to cause cancer" in accordance with the Safe Drinking Water and Toxic Enforcement Act of 1986 under Prop 65. This listing will result in the requirement that all such products, if sold in California, carry a label warning against its alleged carcinogenic effect.

Sunday, May 7, 2017

CAFO and Farms May Have to Comply with Additional Emissions Reporting Requirements

By Lee N. Smith/Craig A. Tristao

Under the Waterkeeper case the D.C. Circuit held that a 2008 rulemaking that exempted certain CAFO’s and farms from emission reporting requirements under certain statutes was improper. Large animal farms and dairies will now be required to report more air pollution from animal waste after the D.C. Circuit April 11 vacated the Environmental Protection Agency rule (Waterkeeper Alliance v. EPA , 2017 BL 117866, D.C. Cir., No. 09-1017, 4/11/17 ).

There are several reporting requirements for the release of certain defined hazardous chemicals, including ammonia.  The two statutes at issue are overlapping. For instance if there were a release from a covered  facility of ammonia, there would have to be reporting under both statutes.

 On December 18, 2008, the US EPA published a final rule that clarified which livestock facilities must report air emissions from their facilities. The two regulations covered by that publication include the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and EPCRA (Emergency Planning and Community Right to Know Act).
Animal agriculture was granted an administrative exemption from reporting air emissions that normally occur from raising farm animals under CERCLA. EPCRA Reporting exemption applied to dairies and Farms that are not large Concentrated Animal Feeding Operations (CAFOs) according to NPDES permitting rules. Without this exemption, much more wide-spread and rigorous reporting would be required.
Passage of the 2008 final rule provided a legal exemption that applies to most livestock operations and clarifies where the exemption does not apply – essentially for large CAFOs under EPCRA. EPCRA requires that, whenever there is a known release of a hazardous substance, the person in charge of a facility must notify state and local emergency responders.
The decision could affect the 15,500 CAFOs operating in the U.S., according to numbers from the EPA. A CAFO under the NPDES definition is a farm that confines more than a certain number of animals—for example, over 1,000 cattle, 2,500 hogs, or 125,000 chickens.
The EPA based its exemption on its view that reports of air releases from CAFOs and farms was unnecessary because a federal response to the releases is generally impractical and speculative. Environmental groups including the Waterkeeper Alliance challenged the rule as a violation of the Comprehensive Environmental Response, Compensation and Liability Act and the Emergency Planning and Community Right-to-Know Act.
Judge Williams, for the D.C. Circuit, found that the EPA did not have the statutory authority to grant the reporting exemptions under CERCLA and EPCRA. Although the EPA argued its exemptions were appropriate because CERCLA and EPCRA already contained other exemptions the Court held that it does not “give the agency carte blanche to ignore the statute whenever it decides the reporting requirements aren’t worth the trouble,”  
The court pointed to examples where people have been injured by animal waste air releases and measures farms can take to reduce injuries. “The record therefore suggests the potentiality of some real benefits” from reporting hazardous substance releases, the court concluded. Regulation of CAFO reporting is to be based upon ‘good faith emissions estimates’.Thus dairies and other farming operations that have emissions over the reporting thresholds must report under both CERCLA and EPCRA. A limited number of approaches for obtaining estimates are available. For most types of animal feeding operations, ammonia emissions are likely to trigger a reporting requirement, with reporting of hydrogen sulfide being much less likely.

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.