CALIFORNIA PROP 65 /BPA UPDATE - PMMI · to modify definition of point of sale. – Vending machines, etc. – Other containers or food products (including fresh) that may need warnings

CALIFORNIA PROP 65 /BPA UPDATE

MJN Confidential and Proprietary Information 2

AGENDA

• Background

• Prop 65 Notification Requirements

• Prop 65 “Label” Examples

• Why is a Safe Harbor Limit important?

• MJN approach

• Recent industry efforts


Background • Bisphenol A (BPA) is a material used in the manufacture of polycarbonate plastics and

epoxy coatings which are used in the linings and coatings for food and beverage cans & metal closures

• Residual free BPA monomer remains at low levels which can extract into food products

• May 2013: California banned BPA for use in baby bottles and sippy cups

• May 2015: OEHHA (office of Environmental health, hazard analysis) added to prop 65 list as a chemical known to cause reproductive toxicity

• Effective date for labeling is 1 year after a new chemical is added to Prop 65 - all products on shelf as of that date

• OEHHA has declined requests to define a MADL or Safe Harbor limit, stating that additional low dose studies may be needed to set a level

• Strong industry effort to apply pressure to have OEHHA define the acceptable exposure limit


Prop 65 Notification Requirements

• Businesses required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical.

• Types of warnings can include – Labeling a consumer product – Posting signs at the workplace – Distributing notices at a rental housing complex – Publishing notices in a newspaper

• Once a chemical is listed, businesses have 12 months to comply with

warning requirements.

http://www.oehha.ca.gov/prop65/law/pdf_zip/RegsArt6.pdf


Prop 65 Label Examples


Why is a Safe Harbor Limit is Important?

• BPA is ubiquitous – Found in air samples at North and South Poles – Possible to have environmental contamination

• Detection limits are very low – Former limit of detection 0.5ppb – Current limit of detection 0.1 ppb


MJN Approach

• Converted interior can coatings to non-epoxy coatings

• Use language in communications and to recommend in any BPA laws language such as: – no intentionally added BPA – BPA is not a component of ….

• CT Approach: converted to plastic bottles despite use of non-BPA coatings in metal cans

• CA Prop 65 Risk Assessment

• Active involvement in coalition


Coalition Efforts

• Strong desire for OEHHA to set a MADL/Save Harbor Level

• Multiple meetings/discussions with EPA and CA executive leaders

• Developed talking points for use with legislators

• Industry/Coalition letter with 41 signatures provided to CA governor

• Today: – Coalition meeting with Cal EPA Secretary Rodriguez at 6:00pm (eastern time) – Recap telecon at 7:30pm (eastern time) – First proposals from EPA expected

We urge you to have OEHHA use the FDA/Delclos study as the basis for the MADL and adopt a safe harbor level of 157 ug while preserving the right to revise this level at a later date. Doing so ensures that sound science determines the safe harbor level for BPA.”


PMC Member Questions

• Does the CA BPA listed in Prop 65 affect your products or packaging? • Do you have an action plan in place?

• Do you feel that any level of BPA found in your products/packaging will not cause “”significant

risk?”

• Can you share (in general) your company’s approach?


APPENDIX


OEHHA – Summary from March 10 Meeting with CalEPA and OEHHA

http://www.oehha.ca.gov/prop65/whats_new/index.html

Emergency Regulation for Warning Program: A few key provisions:

1. Warning regulation covers “canned and bottled foods and beverages” which means foods and beverages packaged in hermetically sealed, durable metal or glass containers; including, but not limited to those containing fruits, vegetables, soups, pasta products, milk, soda, and alcoholic beverages. 2. Signage must be a minimum of 5 inches by 5 inches. 3. Signs to be located in check out areas. 4. Internet notice provided before transaction is completed. 5. A trade association or other authorized agent may act on behalf of the manufacturer, distributor or importer in distributing the signs. 6. No signature is required for proof of delivery per the regulation. 7. Emergency regulation operative for one-year.

REQUIRED LANGUAGE: WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is a chemical known to the State of California to cause harm to the female reproductive system. For more information go to: www.P65Warnings.ca.gov/BPA.

http://www.oehha.ca.gov/prop65/whats_new/index.html

http://www.p65warnings.ca.gov/BPA


Emergency CA Reg to Issue (1) Meeting with CalEPA Secretary on 3/11/2016

Amending regulation to allow for point of sale warning for food and beverage cans and bottles with an 8x8 sign with language as follows:

• WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is known to the State of California to cause harm to the female reproductive system. For more information, go to www.oehha.ca.gov/xxxx.

• Split responsibility between product manufacturer and retailer • Manufacturer would inform retailer and provide signs • Retailer would post signs – usually at cash register

http://www.oehha.ca.gov/xxxx


Emergency Reg (2)

• CalEPA and OEHHA believes this will mitigate problems related to: – Concerns with cans and bottles in commerce and potential chaos come May 2016 – Also recognized that some companies may pull food rather than incur legal liability – Avoids multiple signs all over stores creating excessive signage and consumer angst – Allows for consistent messaging – Existing Proposition 65 warning options would still be allowed on products as an

alternative to POS

• Proposed Emergency Regulations to be in place for six months, then replaced by normal regulations with a sunset of one year with potential for a one year extension. Therefore, point of sale signage option available for at least 18 months.

• Issues raised by Coalition that may still be considered before release of

Emergency Regulation: – Further dialogue/consideration would be needed to address internet sales. May need

to modify definition of point of sale. – Vending machines, etc. – Other containers or food products (including fresh) that may need warnings. – Limiting legal exposure if missing sign – Reduce sign size to 5x5 from proposed 8x8.


Emergency Reg (3)

• ATTORNEY GENERAL CONSENT JUDGEMENT – CalEPA suggests that there may be an option to dialogue with AG for a settlement as

companies work to reformulate – This option protects against third party lawsuits – plus gives certainty for timelines and

covers uncertainties of future MADL – Not a mechanism for delay or averting requirements – AG would have to agree but CalEPA believes preliminary feedback is positive. AG

has not been formally approached on this yet.


OEHHA Website

• What types of chemicals are on the Proposition 65 list?

– The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust.

• If there is no safe harbor level for a chemical, businesses that expose individuals to that chemical would be required to provide a Proposition 65 warning, unless the business can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm.

Documents

CALIFORNIA PROP 65 /BPA UPDATE - PMMI · to modify definition of point of sale. – Vending machines, etc. – Other containers or food products (including fresh) that may need warnings