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.)

Saturday, December 23, 2017

CEQA Guidelines Revisions

The  Office of Planning and Research (OPR) has issued a final version of its proposed revisions to the CEQA guidelines. The Natural Resources Agency will soon begin the formal administrative rule making process under the Administrative Procedure Act. This rule making process will entail additional public review, and may lead to further revisions. After completing the  process, the Secretary for the Natural Resources Agency may adopt the changes. Changes would only go into effect after the Office of Administrative Law reviews and approves them.

The agency has divided the amendments into three categories—Efficiency Improvements,Substantive Improvements and Technical Improvements. The following was taken from the Executive Summary for the Proposed Update in November 2017.

 Efficiency Improvements

First, the amendments promote  use of existing regulatory standards in the CEQA process. Using standards as “thresholds of significance” creates a predictable starting point for the analysis, and allows agencies to rely on the expertise of other regulatory bodies, without foreclosing consideration of possible project specific effects.

 Second, the amendments propose to update the environmental checklist that most agencies use to conduct their environmental review. Redundant questions in the existing checklist would be eliminated and some questions would be updated to address contemporary topics. The checklist has also been updated with new questions related to transportation and wildfire.

Third, the amendments include several changes to make existing programmatic environmental review easier to use for later projects. Specifically, it clarifies the rules on tiering, and provides additional guidance on when a later project may be considered within the scope of a program EIR thereby obviating the need for additional environmental review.

Fourth, the amendments revise several exemptions expanding an existing exemption for projects implementing a specific plan to include not just residential, but also commercial and mixed-use projects near transit. It also clarifies the rules on the exemption for changes to existing facilities so that vacant buildings can more easily be redeveloped. Changes to that same exemption would also promote pedestrian, bicycle, and streetscape improvements within an existing right of way.

Finally, the amendments include a new section to assist agencies in complying with CEQA in response to a court’s remand, and to help the public and project proponents understand the effect of the remand on project implementation.

Substantive Improvements

First, the Substantive Improvement amendments would provide guidance regarding an energy impacts analysis. Specifically, it would require an EIR to include an analysis of a project’s energy impacts that addresses not just building design, but also transportation, equipment use, location, and other relevant factors.

Second, the Substantive Improvement amendments propose guidance on the analysis of water supply impacts.  It requires analysis of a proposed project’s possible sources of water supply over the life of the project and the environmental impacts of supplying that water to the project. The analysis must consider any uncertainties in supply, as well as potential alternatives.

Third, the Substantive Improvement amendments includes propose  updates related to analyzing transportation impacts pursuant to Senate Bill 743. These updates will specify that vehicle miles travelled is the appropriate measure of transportation impacts for most projects.

 Finally, the amendments include proposed updates related to analyzing the impacts from greenhouse gas emissions. 

 It adds that the focus of the GHG analysis should be “on the project’s effect on climate change” and should not focus on “the quantity of emissions, and in particular how that quantity of emissions compares to statewide or global emissions.” Agencies  should “consider the reasonably foreseeable incremental contribution of the project’s emissions to the effects of climate change,” but avoid speculation, according to OPR

The changes also direct agencies to consider appropriate time frames for the GHG analysis of their project, noting that in some cases, it would be appropriate for agencies to consider a project’s long-term greenhouse gas impacts, such as for projects with long time horizons for implementation. The changes clarify that agencies can rely on existing GHG reduction plans, such as Climate Action Plans, when conducting
the GHG analysis.

Technical Improvements

The Technical Improvement amendments also include  technical changes to conform to recent cases and statutory changes. For example, it includes changes related to evaluation of hazards mandated by the California Supreme Court in CBIA v. BAAQMD (2015) 62 Cal.4th 369.

Another change clarifies when it may be appropriate to use projected future conditions as the environmental baseline. Another change addresses when agencies may defer specific details of mitigation measures until after project approval.

The Technical Improvement amendments also propose a set of changes related to the duty of lead agencies to provide detailed responses to comments on a project. The changes would clarify that a general response may be appropriate when a comment submits voluminous data and information without explaining its relevance to the project. Other changes address a range of topics such as selecting the lead agency, posting notices with county clerks, clarifying the definition of “discretionary,” and others.

 Finally, the amendments include technical changes to Appendices D and E to reflect recent statutory requirements and previously adopted amendments to the CEQA Guidelines, and to correct typographical errors.

 Additional Technical Improvements include those related to: pre-approval agreements; lead agency by agreement; common sense exemption; preparing the initial study; consultation with transit agencies; citations in environmental documents; posting notices with the county clerk; time limits for negative  declarations; project benefits; joint NEPA/CEQA documents; using the emergency exemption; discretionary projects; conservation easements as mitigation; and Appendices C and M to the CEQA Guidelines.

Friday, December 15, 2017

Appellate Court Upholds Nuisance Claim against Paint Companies for Lead/Lead Renovation, Repair and Painting Rule

A state appellate court has upheld a trial court decision that found paint companies created a public nuisance by promoting lead paint use in residential homes, although it reduced the $1.15 billion award, and limited the relevant time period to pre-1951. See People v. ConAgra Grocery Products Company, Opinion, H040880 (6th Cal. App filed Nov. 14, 2017).
The Counties of Alameda, Los Angeles, Monterey, San Francisco, San Mateo, Santa Clara, Solano and Ventura Counties,  and the cities of Oakland and San Diego sued ConAgra Grocery Products Company, NL Industries, Inc. and the Sherwin-Williams Company seeking  cleanup of lead-contaminated from paint in homes. 
In 2013, a Santa Clara County Superior Court ruled that the paint companies created a public nuisance by promoting lead paint use despite being  aware of serious health threats. The court ordered the companies to pay $1.15 billion into a lead paint abatement fund to rehabilitate homes built prior to 1980. Paint manufacturers have successfully fought off similar suits filed in other states by local governments seeking to hold them accountable for lead paint contamination. The appellate court however, based on a lack of evidence, was limited abatement to pre-1951 paint applications as there was no evidence promotion continued after that time.
We would note that there is also a federal law, that is being enforced in California that regulates in a manner similar to asbestos, the way that the construction and remodeling projects have to manage lead paint covered surfaces in houses.. 
EPA's Lead Renovation, Repair and Painting Rule (RRP Rule) requires that firms performing renovation, repair, and painting projects that disturb lead-based paint in homes, child care facilities and pre-schools built before 1978 have their firm certified by EPA (or an EPA authorized state), use certified renovators who are trained by EPA-approved training providers and follow lead-safe work practices.
See https://www.epa.gov/lead/renovation-repair-and-painting-program  

Thursday, December 14, 2017

Prop 65- Revision to Warning Requirements

In December 2017 OEHHA finalized minor amendments to the new Labeling requirements. Most of the changes are not substantive and were meant to clarify the existing regulations.

Subsequent to the adoption of the August 2016 amendments to the Article 6 Clear and
Reasonable Warnings regulations, the Office of Environmental Health Hazard
Assessment (OEHHA) received numerous inquiries related to the interpretation and
application of several provisions of the amended regulations. OEHHA therefore
determined that clarification of certain provisions of the new regulations would be
beneficial to the regulated community. The proposed amendments are intended to
further clarify the guidance OEHHA provides to businesses to better understand how to
comply with the warning requirements.

 Final Statement of Reasons p.3


Thursday, December 7, 2017

Chlorpyrifos listed under Prop 65

Pursuant to Prop 65 the Developmental and Reproductive Toxicity Identification Committee (DARTIC) under OEHHA made the decision to list chlorpyrifos under Proposition 65 as a developmental toxicant. Chlorpyrifos is one of the most widely-used active ingredients in agricultural insect control products in the world. It was first registered in the U.S. in 1965 and has been on the market for more than forty-five years. Products containing chlorpyrifos will have to be appropriately labeled by late 2018.

Chlorpyrifos was previously considered by the DARTIC in 2008, but was not added to the Proposition 65 list at that time.  Substantial new data on developmental toxicity has become available since the chemical was previously considered for listing. Many groups have pushed to get chlorpyrifos off the market entirely. The Obama administration proposed an all-out ban in 2015. President Donald Trump's appointed Environmental Protection Agency administrator Scott Pruitt ruled in spring 2017 that he would not ban the chemical.  

Chlorpyrifos is an organophosphate insecticide. Pure chlorpyrifos is made up of white or colorless crystals. It has a slight odor.  Chlorpyrifos is used to control many different kinds of pests, including termites, mosquitoes, and roundworms. Chlorpyrifos was first registered as an insecticide in 1965 and the United States Environmental Protection Agency (US EPA) re-registered it in 2006. The only legal indoor use for chlorpyrifos is in containers with treated baits.
The crops with the most use are cotton, corn, almonds and fruit trees including oranges, bananas and apples.  

Alfalfa weevil, armyworms, aphids, potato leafhoppers.
Brassica Vegetables (Cole Crops)
(Broccoli, Cauliflower, Cabbage, Kale, Rutabaga, Turnips, etc.)
Cabbage maggot, aphids
Scale insects, mealybug, Asian citrus psyllid, rust mite, citrus leaf miner, katydids.
Corn, Field
Corn rootworm, cutworm, white grub, European corn borer
Corn, Sweet
corn earworm, armyworms, corn rootworm (larvae and adult), cutworms, seed corn maggot, wireworms
Cotton aphid, Lygus bug, armyworms, pnk bollworm
Mealybugs, cutworms, ants
mint root borer
Onion maggot
Lesser cornstalk borer, corn rootworms, white mold
Pome Fruits
(Apples, Pears)
San Jose scale, rosy apple aphid, pandemis leafroller, oblique-banded leafroller, climbing cutworms, American plum borer
Soybean aphid, bean leaf beetle, grasshoppers, spider mites
Stone Fruits
(Peaches, Nectarines, Cherries, Plums)
San Jose scale, peach twig borer, peaach twig borer, peach tree borer, lesser peach tree borer, American plum borer
Sugar Beets
cutworm, wireworm, sugarbeet root maggot, armyworms, grasshoppers
Sweet Potatoes
Wireworms, southern corn rootworm, flea beetles
Tree nuts
(Almonds, Pecans, Walnuts, etc.)
San Jose scale, peach twig borer, navel orangeworm, codling moth, walnut husk fly, walnut aphid, pecan nut casebearer, black pecan aphid
Aphids, grasshoppers, orange wheatblossom midge

The Office of Environmental Health Hazard Assessment (OEHHA) also has listed perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as reproductive toxicants under Proposition 65.

PFOA and PFOS are surfactants that have been used in a variety of consumer products, including carpets, textiles, leather, non-stick cookware, and paper coatings used in food packaging, to confer stain, grease and water resistance.

 Manufacturing of PFOS was ended in 2002 and PFOA production ceased in 2015.

Wednesday, December 6, 2017

Air Quality Presentation to the Manufacturers Council of the Central Valley 12/06/2017

Lee N. Smith along with David Duke of Foster Farms presented these  Power Points concerning the major Air Quality Issues facing the San Joaquin Valley, to the Board of the Manufacturers Council of the Central Valley at their Annual Board Meeting on December 6, 2017.  Please contact Mr. Smith if you like a copy of the presentation.

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.
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


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 
             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.