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, October 19, 2017

Prop 65 Certificate of Merit- Assembly Bill No. 1583 Passed


The Governor signed AB No. 1583. The bill that would allow discovery of the basis for the certificate of merit in a 60 Day Notice was signed by the governor:
If the notice made by a person bringing an action in the public interest alleges a violation of the act’s warning requirement, existing law requires that the notice include a certificate of merit stating that the person executing the certificate has consulted with one or more persons with relevant and appropriate experience or expertise who has reviewed facts, studies, or other data regarding the exposure to the listed chemical that is the subject of the action, and that, based on that information, the person believes there is a reasonable and meritorious case for the                                                         private action. 
Existing law requires factual information sufficient to establish the basis of the certificate of merit to be attached to the certificate of merit that is served on the Attorney General.
This bill would require, if the Attorney General believes there is no merit to the action after reviewing the factual information sufficient 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 to serve a letter to the noticing party and the alleged violator stating the Attorney General believes there is no merit to the action, as specified.
and
This bill would make the basis for the certificate of merit 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.

Environmental Law for Developers in California







Saturday, September 30, 2017

Summary of New Prop 65 Regulations


On September 25 we attended the Prop 65 Clearinghouse Annual Conference. 

Most of the conference concerned how to comply with the new labeling regulations which are effective as of August 2018.

Below is a summary of the new regulations:

Posted by Lee N. Smith


                                                              SUMMARY

A.      In summary, there is new safe harbor language, a new website for consumers,and language which attempts to clarify liability as between manufacturers and retailers. Most significantly the new regulation asserts that for retailers to be liable actual knowledge must be imputed to them. This would not apply to companies that custom label products.

B. The new regulations go into effect on August 30,  2018,  new  labels  can however be used before that time, if the business desires.

C. The language required by earlier Consent Judgments is considered within safe harbor, even in the older format.

D.    The new labels contain language that requires the identification of at least one of the 
Proposition 65 chemicals in the product, and identifies the public website.

E. The language for each of the types of warnings other than labelling (i.e. environmental vs. 
product) has also changed but are not addressed here.

F.       The  emphasis  in  the  regulations  is  for  liability  to  the  manufacturer  for 
Proposition 65; along with additional duties placed on vendors.

               a.   Product manufacturers have primary responsibility for warning.
               b. The manufacturer can label product or provide notice to distributors/importers/retailers or 
sellers that a product may cause an exposure to a listed chemical.
              c.   Provide warning signs, materials (unless they make other arrangements via contract) to 
retailers.
             d.   The retailers must have actual knowledge of the chemicals to be liable.

G.       Labeling
            a.   Safe Harbor Content and Methods
                     i.    “This product contains [specific chemical]”
                     ii.    “This product can expose you to [specific chemical]”
                     iii.    The name of at least one chemical in the warning.
                    iv.    Named chemicals are those for which warning is being provided.
                     v.    Warning symbol
                     vi.   Provide non-English language warnings in certain situations.

H.      Phase In Effective date of regulation: August 30, 2018.

I.        Consumer products manufactured prior to the effective date will not require new warnings if they meet existing safe harbor requirements.

J.       Court-approved  warnings  expressly  recognized  and  considered  “clear  and reasonable” for parties to litigation.

K.      Tailored Warnings; In Addition To The Specific Warnings Listed Above, The Code Has Modified The Warnings For The Following Categories:
           a.   Environmental Exposure
           b.   Occupational Exposure
           c.   Alcoholic Beverages
           d.   Food and Non-Alcoholic Beverages
           e.   Prescription  Drug  Exposure  and  Emergency  Medical  or  Dental  Care Exposure
           f.   Dental Care
           g.   Raw Wood Products
           h.   Furniture Products
           i.   Diesel Engines
           j.   Vehicles
           k.   Recreational Vessels
           l.   Enclosed Parking Facilities
          m. Amusement Parks
          n.  Petroleum Products
          o.  Service Station and Vehicle Repair
          p.   Designated Smoking Areas
          q.   Exposure to Bisphenol A from Canned and Bottled Foods and Beverages

Please feel free to contact us if you have any questions.

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.

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.

Amended Notice Regulations for Prop 65

OEHHA,  the Office of Environmental Health Hazard Assessment, has released yet another iteration of the “fair and reasonable” standard for Prop 65 warnings. This March draft contains numerous changes mostly minor changes to try to increase the clarity of the language. Originally in March of 2014, OEHHA i
ssued a “pre-regulatory draft” of the regulations, and after several iterations OEHHA issued a revised formal proposal in January of 2016. These changes are a result of comments on that version. The Website called for in the original revision of the regulations to clarify warnings is already online see:
Among the more substantive changes are the following:
  • The last version allowed supplemental language in the warning as long as it does not contradict the language in the warning. However, with these changes the Supplemental information can be used as part of a warning only to the extent that it explains the source of the exposure or provides information on how to avoid or reduce the exposure.
  • The new draft eliminates the option that was previously provided that would allow a manufacturer to meet its labeling requirements by providing labeling materials and/or signs to downstream suppliers, now however the responsible party (manufacturer, importer, supplier, etc.) must actually provide those materials unless there is an agreement otherwise.
  • Retail seller is responsible for internet warnings.
  • The November draft imposed the warning obligation on the retailer where it has “actual knowledge” of the potential consumer product exposure and where there is no manufacturer or other responsible party available to provide the warning. The draft defined “actual knowledge” as occurring within two days after the retailer receives a Prop. 65 notice intent-to-sue notice, this period has been extended to five days. A retailer may label during that period and avoid liability.
  • A business may satisfy its warning obligation by including by name only one of the chemicals for which the business has determined that a warning is required.
  • Where there are chemicals in the product with different warning requirements (i.e., a carcinogen and a reproductive toxicant) then the warning must include one chemical from each group. OEHHA has also dropped language requiring that the named chemical actually be present in levels above the safe harbor level for that chemical.
  • A warning provided before the two year effective date will be deemed to be clear and reasonable.
  • OEHHA has also added new sections defining “consumer product exposure” and “environmental exposure” and the requisite warnings that must be displayed. They also eliminated any requirement for type size beyond requiring the warnings to be “conspicuous” in relation to other product label or sign language.

PME Speakers at Cal. League of Food Processor’s Food Safety, Nutrition and Labeling Committee

   PME lawyers Lee Smith and Craig Tristao spoke at the CLFP’s Food Safety Nutrition and Labeling Committee, on May 16, 2016. They covered the topics of the State Water Board’s Proposed General Order for Recycled Water and on the use of Production Water on Agricultural. If you are interested in the PowerPoints or having a repeat performance of the presentation please contact us.

Prop 65: Revisions to Proposed Regulations

By: Lee N. Smith
California’s Office of Environmental Health Hazard Assessment (“OEHHA”) has released a new, revised version of the proposed Proposition 65 warning regulations apparently because they could
not finish their rulemaking within one year, as required by law.  The delay was caused reportedly by problems that the Agency was having in reconciling the diverse views demonstrated by the public comments and surveys generated by the last round of regulations.  The Agency announced over the 2015 Thanksgiving holiday weekend that it was withdrawing the January 2015 proposal for the warning regulations and replacing it with this alternate proposal. Although the new regulations attempt to address some of the more controversial issues that were contained in the earlier versions there are still some portions of the revised regulations that will continue to trouble industry.  Comments are due on January 22, 2016. The Notice can be found here:
The new regulations revise the proposed safe harbor warning language to include the statement that the chemical “can” expose a person to proposition 65 chemicals and substances as opposed to the “will” expose language that had been suggested earlier. They also eliminated the regulation that would have required that the 12 most common Proposition 65 chemicals and the related compounds to be set out in the warning. The proposal provides little guidance or definition of what constitutes a clear and reasonable warning but does suggest that manufacturers and retailers name one of the chemicals subject to the warning and potential liability for failing to identify other chemicals that may be present.
The generic safe harbor warning has the following elements:
  1. A symbol consisting of a black exclamation point in a yellow equilateral triangle.  Where the sign, label or labeling for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.
2.  The word “WARNING” in all capital letters and bold print, and
(A)  For exposures to listed carcinogens, the words, “This product can expose you to [name of one or more chemicals], a chemical [or chemicals] known to the State of California to cause For more information go to www.P65Warnings.ca.gov/product.
(B)  For exposures to listed reproductive toxicants, the words, “This product can expose you to [name of one or more chemicals], a chemical [or chemicals] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/product.
(C)  For exposures to listed carcinogens and reproductive toxicants, the words, “This product can expose you to [name of one or more chemicals] a chemical [or chemicals] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/product.
The Agency set forth an example in its Power Points for a January meeting:


Warnings provided pursuant to a court approved settlement or by a filed consent judgment are presumed to be “clear and reasonable” This provision does not apply to out-of-court settlements making that avenue of settlement even less attractive than before.
Another change in the proposal would prevent unnecessary labeling of mandatory inventory by dropping the sell through limitations. This was an issue because parts manufactured before the adoption would have to be relabeled if they were manufactured two years after adoption of these regulations. The November draft fixes this problem by providing that products manufactured prior to the deadline considered clear and reasonable if it is in compliance with the prior 2008 regulations.
The following is a summary of the significant revised regulations:
1)         Two Years before it becomes effective;
2)        An interested party can request approval of a warning method or content specific to a content area pursuant to Section 25607;
3)         Supplemental information from the labeling can be provide to consumers, but it cannot contradict the warning;
4)        A person is not required to provide separate warnings to each exposed individual;
5)         A person that is a party to a court order settlement of final judgment establishing a method or content for a consumer product of environmental warning is deemed to be clear and reasonable;
6)          Provides a method for the manufacturers to provide warning and instructions to retailers;
7)          The regulation provides circumstances under which retailer is required to provide their own labels;
8)         Retail seller is required to provide information to various parties as to the identity of manufacturers;
9)         Parties can enter into agreements allocating liability for warnings;
10)      Except as provided in Section 25603(c), a warning meets the requirements of this article if the name of one or more of the listed chemicals for which the warning is being provided is included in the text of the warning, to the extent that an exposure to that chemical or chemicals is at a level that requires a warning;
11)     The regulations contain specific requirements for the new labels, including point type;
12)      There are requirements for sales over the internet and catalog purchases;
13)      If any label, labeling or sign that provides consumer information about a product is provided in a language or languages other than or in addition to English, then a warning for that product meets the requirements of this article only if the warning is also provided in the same language or languages on that label, labeling or sign.
Section 25607 provides warning methods and content for specific types of exposures that are subject to the warning requirements of Section 25249.6 of the Act, and must be used for the indicated products in order to meet the safe harbor requirement.   These products include:
  1. Food
  2. Alcohol Specific warning requirements for alcohol products,
  3. Wood Dust
  4. Raw wood products
  5. Furniture
The specific warnings for these products can be found in the direct regulations at Section 25607.  Initial public comments are due on January 22, 2016.