I fSTATE OF CALIFORNIA--OFFICEOFADMINISTRATIVE " ~ i,i J f ~ '~— t~ ` ~ i ~ ~~~ ~ ~ ~ in UCtiOnS On For use by Secretary of State only NOTICE PUBLICATION/R ~~T~~1~=~~i Vi~$t f'1I- reverse)STG. 400 (REV.Ot-2p73)
OAL FILE NOTICE FILE NUMBER REGULATORY ACTION NUMBER EMERGENCY NUMBER~~~BERS Z_ .~Dlb• o~~.~ •o?~~ __For use by Office of Administrative Law
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NOTICE REGULATIONS
AGE CY WITH RULEMAKING AUTHORITY AGENCY FILE NUMBER (If any)
C~'-~~~e c~ v. ~r~-~~.t ~N~ Z~rd s~~sm~rrf
A. PUBLICATION OF NOTICE (Complete far publication in Notice Register)
1. SUBJECT OF NOTICE TITLES) FIRST SECTION AFFECTED 2. REQUESTED PUBLICATION DATE
3. NOTICE TYPE 4. AGENCY CONTACT PERSON TELEPHONE NUMBER FAX NUMBER (Optional)Notice re Proposed
Re uiato Action ~ Other
OAL USE AC 710N ON PRQPOSED NOTICE. 1 YOT C E= RcG~STE-R 'V IJfUBtR F'UBLGA ilO^l CATS~~~~ ~ Approved as (~ Appro ~d as ~ De;ap~ rz~~v~~i= '..Suhmiri~,n ~ _ -- ~ w r -. ~~ Wrtha awc
B. SUBMISSION OF REGULATIONS (Complete when submitting regulations)
1a. SUBJECT OF RED 1.R~'TIQ ~~ R,. „ ~ 1b. ALL PREVIOUS RELATED OAL REGULATORY ACTION NUMBERS)t4> S (•
Proposition 65 Warning Requirements ~,~~_~~ 2016-0408-02E
2. SPECIFYCALIfORN1ACO0EOFREGULATIONSTITLE(S)ANDSECT~ON(S) gncludingtitle26,iftoxicsrelated)
SECTIONS) AFFECTED ADOPT
List all section numbers)
individually. Attach A"'ENo
additional sheet if needed.) 256033
TITiE(S) REPEAL
2~
3. TYPE OF FILING
r1 Regular Ruiemaking (Gov. ~ certificate of Compliance: The agency officer named Emergency Readopt (Gov. Changes Without Regulatory ~ Code §11346) below certifies that this agency complied with the ~ Code, 411346.1 {h)) ~ Effect (Cal. Code Regs., title❑ Resubmittal of disapproved or provisions of Gov. Code §§11346.2-173473 either 1, §100)withdrawn nonemergency before the emergency regulation was adopted orfiling (Gov. Code §§11349.3, within the time period required by statute. ❑ F~~e &Print ~ Print Only
17 349.4)
i-1 Emergency (Gov. Code, ❑ Resubmittai of disapprpved or withdrawn ~ Other (Specify)~--j §1134b.1{b)) emergency filing(Gov.Code, §11346.1)
4. ALL BEGINNING AND ENDING DATES OF AVAILABILITY OF MODIFIED REGULATIONS AND10R MATERIAL ADDED TO THE RULEMAK~NG FILE (Cal. Code Regs. title 7, §44 and Gov. Code 471347.7)
S. EFFECTIVE DATE OF CHANGES (Gov. Code, §3 11343:4, 7 7346.7(d); Cal. Code Regs., title i, §700 )(~ Effective January t, Aprii 1, July 1, or Effective on filing with §700 Changes Without Effective~__~ October t (Gov. Code §11343.4(a)) ~ Secretary of State ~ Regulatory Effect ~ other (Specify)
6. CHECK IF THESE REGULATIONS REQUIRE NOTICE TO, OR REVIEW, CONSULTATION, APPROVAL OR CONCURRENCE BY, ANOTHER AGENCY OR ENTITY
Department of Finance (Form STD. 399) (SAM §6660) ❑ Fair Political Practices Commission ~ State Fire Marshal
j other(Speciy)
7. CONTACT PERSON TELEPHONE NUMBER FAX NUMBER (Optional)
Monet Vela (916) 323-2517
~~ 1 certify that the attached copy of the regulations) is a true and correct copy For use by
of the regulations) identified on this form, that the information specified on this form
is true and correct, and that i am the head of the agency taking this action,
or a d3signee of the head of the agency, and am authorized to make this certification.~-SIGNATU OF AGEN OR D NEE DATE
TYPE AME AND TITL SIGNATORY
Carol Monahan-Cummings, Chief CounselE-MAIL
~A.~. ~G`A.~tiC~U
Section 25603.3 Warnings for Specific Consumer Products Exposure.
(~ Responsibility to Provide Warnings for Exposure to Bisphenol A from Canned
and .Bottled Foods and Beverages.
(1 } Notwithstanding any other provision of sections 25603, 25603.1, 25603.2, and
25603.3, canned and bottled foods and beverages that are offered for retail sale in
California after May 10, 2016, that contain bisphenol A, are deemed to comply with
the warning requirements of section 25249.6 of the Act if the following provisions are
met:
(A) The manufacturer, producer, packager, importer or distributor of the canned and
bottled food or beverage either:
1. Affixes a label to the product bearing a warning that complies with section
25603.2(a)2., or
2. Provides written notice directly or through an authorized agent or trade
association to the retailer or its authorized agent. The written notice must:
a. State that the .canned or bottled food or beverage may result in an
exposure to bisphenol A; and
b. Include the name or description of the canned or bottled foods or
beverages, such as a Universal Product Code or other identifying
designation; and
c. Provide, or offer to provide, to the retail seller, at no cost, a sufficient
number of point-of-sale warning signs that satisfy the requirements of
subsection (g).
(2) If a retail seller receives a notice pursuant to subsection (1)(A)2., the retail seller
must post a warning sign that satisfies subsection (g) at each point of sale in the
retail facility. The placement and maintenance of warning signs is the responsibility
of the retail seller.
(A) Where a retail seller complies with all the provisions of subsections (f) and (g),
an opportunity to cure exists to correct the absence of the warning sign, which:
1. Is not the result of intentional neglect or disregard for the requirements
of this section, and
2. Is not avoidable using normal and customary quality control or
maintenance, and
3. Is corrected within 24 hours of discovery or notification.
(3) For purposes of subsection (f) and subsection (g), "canned and bottled foods and
beverages" means foods and beverages packaged in hermetically sealed, durable
metal ar glass containers, including, but not limited to, those containing fruits,
vegetables, soups, pasta products, milk, soda, and alcoholic beverages.
(4) For purposes of subsection (f) and subsection (g), "point of sale" means the area
within a retail facility where customers pay for foods and beverages, such as the
cash register or checkout line where the warning sign is likely to be seen and
understood, prior to the .consumer purchasing the canned or bottled food or
beverage. Point of sale also includes electronic checkout functions on Internet
websites.
(5) This subsection shall become inoperative one year after the date of adoption
unless reenacted by the lead agency.
(g) Warnings for Exposure to Bisphenol A from Canned and Bottled. Foods and
Beverages.
(1) Method of Transmission:
Warnings for canned and bottled foods and beverages, as defined in subsection
(f) (3), that contain bisphenol A shall be provided at each point of sale, as defined in
subsection (f)(4), by posting a warning sign that includes the language set out in
subsection (g)(2): Such warning signs must be no smaller than 5 by 5 inchesand be
displayed with such .conspicuousness, as compared with other words, statements,
designs, or devices at the point of sale, as to render it likely to be read and
understood by an ordinary individual prior to purchase of the products that contain
bisphenol A. For products sold over the Internet, the warning must be prominently
displayed to the purchaser either on the product display page or otherwise an a
webpage prior to completing the purchase.
(2) Content of Warning Sign:
(A) The word "WARNING" in all capital letters and bold print, and
(B) The words: "Many food and beverage cans have linings containing bisphenol
A (BPA), a chemical known to the State of California to cause harm to the
female reproductive system. Jar lids and bottle caps may also contain BPA.
You can be exposed to BPA when you consume foods or beverages
packaged in these containers. For more information go to:
www. P65Warn ings.ca.gov/BPA.
(3) This subsection shall become inoperative one year after the date of adoption
unless reenacted by the lead agency.
NOTE: Authority cited: Sections 25249.12 and 25249.11(f), Health and Safety Code.
Reference: Sections 25249.6, 25249.7(k) and 25249.11, Health and Safety Code.
• • ~'~'•' • i ~ •
TO AMEND SECTION 25603.3
TITLE 27, CALIFORNIA CEDE OF REGULATIONS
-~ - •- . 1
I. INTRODUCTION
The Office of Environmental Health Hazard Assessment (OEHHA) is the state entityresponsible for the implementation of Proposition 85.' OEHHA has the authority toadopt and amend regulations. #o implement and further the purposes of Proposition 65.OEHHA maintains a list of chemicals known to cause. reproductive toxicity or cancer.Proposition 65 requires businesses to provide a warning when they knowingly andintentionally cause an exposure to a listed chemical, and prohibits the discharge oflisted chemicals into sources of drinking water.
On May 11, 20.15, bisphenol A (BPA) was added to the Proposition 65 Iist of chemicalsknown to cause reproductive toxicity based on the. female. reproductive toxicityendpoint? Female reproductive toxicity occurs when a chemical damages any aspectof the female reproductive system. Effective May 11, 2016, warnings are. required forexposures toBPA unless the person causing the exposure can show that an .exposure1,000 times the level in question has no observable effect.3 OEHHA has adopted anemergency regulation to allow temporary use of a standard point-of-sale warning
message. for BPA exposures from canned and .bottled foods and. beverages.4 Thisemergency regulation is in effect for a limited time of 180 days. OEHHA is proposing areadoption of this .emergency regulation for 90 days after the .initial 180-day periodexpires on October 18, 2016.
1 Tne Safe Drinking Water and Toxic Enforcement Act of 1986, codified at Health and Safety Code section 25249.5
et seq., commonly referred to as "Proposition 65".
z http:/loehha.ca.~ov/proposition-65/crnr/bis~henol-listed-known-state-California-cause-reproductive-toxicity
3 Nealth and Safety Code, sections 25249.10(b), 25249.10(c)
' In a separate rulemaking process, OEHHA adopted a Maximum Allowable Dose Level (MADE) that established a
level of dermal exposure to BPA from solid surfaces that does not require a warning. This regulation will become
effective October 1, 2016. The MADE is unrelated to this rulemaking package because exposures from canned and
bottled foods and beverages are not dermal exposures.
• ; t
Proposition 65 was a 1986 ballot initiative that. passed with 63 percent of the popularvote. In part, the statute says:
"No person in the course of doing business shall knowingly and intentionallyexpose ..any individual to a chemical known to the. state to cause .cancer orreproductive toxicity without first giving a clear and reasonable warning..."5
Proposition 65 is a right-to-know law based an the concept that members of the publichave a right to know when they are being exposed to listed carcinogens or reproductivetoxicants. A .Proposition 65 warning. is not a regulatory decision .that a product is safe orunsafe. Rather, the .law is designed to help consumers decide whether. to assume therisks of purchasing particular products that result in exposures to listed chemicals.
BPA is .commonly used in the linings of metal cans and lids of glass bottles containingfood andbeverages. Some BPA can move from these liners and lids into the foodorbeverage, thereby resulting in an exposure to the consumer of the food or beverage...
On April 1, 201.6, QEHHA posted a Notice of Emergency Action proposing anamendment to 25603.3,6 The amendment allows businesses to provide paint-of-salswarnings for food and beverage cans and bottles that cause exposures to BPA. Thisprevented the. need for retailers to post a plethora of signs throughout retail stores thatlikely would have confused consumers. This emergency rulemaking became effectiveon April 18, 2016 and wi)I .expire on .October 5,, 2016.
The emergency regulation that. became effective .April 18, 201.6. is .intended to provide areasonable transition period to help avoid consumer confusion and at the same time..ensure that informative warnings are provided to consumers about significant exposuresto BPA. Businesses throughout the. state of California are. using this temporary warningin the manner outlined in the regulation. However, the emergency regulation can onlyremain in .effect for 180 days and will expire on October 18, 2016 (Government Codesection 11346.1(e)). OEHHA initiated a regular rulemaking process,on July 29, 2016 #oadapt the regulation. The regular rulemaking will not be complete :before the 180 daysexpire. If the. emergency regulation. is allowed to expire .before .the regular rulemakingprocess is completed, California. businesses would lose this temporary warning processand would have to revert to providing a multitude of warnings in retail stores for canned.foods and beverages that cause exposures to BPA.
•
5 Health and Safety Code, section 25249.6
~ htt~~//oehha ca ,~ovl~ro~osition-65/crnrinotice-emer~encX-action-amend-section-256033-title-27-California-code
A. Section 48 Statement
Title 1 of the California Code of Regulations, section 48 requires the followingstatement:
"Government Code section 11346.1 (a)(2) requires that, at least five. workingdays prior to submission of the .proposed emergency action to the Office ofAdministrative Law, the adopting agency provide a notice of proposedemergency action to every person who has filed a request for notice ofregulatory action with the agency. After submission of the proposedemergency to the Office. of Administrative Law., the Office ofAdministrativeLaw shall allow interested persons five calendar days to submit comments onthe proposed. emergency regulations as .set forth in Government Code section11349.6."
B. Incorporation bkReference
All documents in the emergency regulation file no. 2016-0408-02E filed with the Officeof Administrative Law on April 8, 20.16, are hereby incorporated by reference.
C. Facts Constituting the Need for an Emergency Reado~tion
OEHHA has made substantial progress and. proceeded. with diligence toward adoptingthe provisions of the emergency regulation viatheregular rulemaking process. On July19, 2016, OENHA submitted the. initial. #ile for the regular rulemaking process to OAL.The. Notice of Proposed. Rulemakng was. published on .the California Regulatory NoticeRegister on July 29. A public hearing on this. proposed rulemaking was. held on
September 12, 2016, and. public. comments .are due. September 26,..2016.
This. readopton is necessary because the emergency circumstances havenot changedsince .the ini#ial emergency adoption. Further, businesses in .California are relying onthe emergency. regulation to comply with the requirements. of Proposition 65 when
selling their products in cans or bottles that were manufactured before the listing of BPA
became effective. Once the regular rulemaking is complete, these businesses will
continue to have the option to provide point-of-sale warnings until the regulation sunsets
in December 2017. When the .regulation sunsets, OEHHA anticipates that product
manufacturers will have either switched to non-BPA materials or will have. made
arrangements to .provide. product-specific warnings. While it is possible some point ofdisplay shelf. warnings will still be needed, the volume. of such signs. should be
significantly reduced, thus eliminating the need for apoint-of-sale warning.
V. TECHNICAL, THEORETICAL, AND/OR EMPIRICAL STUDY, REPORTS, OR
DQCUMENTS RELIED UPON
Citations to documents relied on for this proposal are provided in this. document and the
documents incorporated by reference herein. No other technical, theoretical or
empirical material was relied upon by OEHHA in proposing the readaption of this
emergency regulation.
VI. AUTHORITY
Health and .Safety Code section 25249.12(a)
VI1. INFORMATIVE DIGEST
A..Background (see Section II, above,
B. Specific Benefits of the Proposed Reaulations
This regulatory readoption is intended to further the purposes of Proposition 65 byemending a temporary emergency regulation that allows for the use of a consistent andinformative. point-of-sale warning for BPA exposures from canned and bottled foods andbeverages. (See Emergency Rulemaking file number 2016-0408-02E incorporated byreference.)
C. No Inconsistency or Incom~atibili~ with Existing Regulations
OEHHA has conducted an evaluation and has determined that this is the only regulationspecifically addressing Proposition 65 warnings for exposures to BPA from canned andbottled foods. Therefore, the proposed emergency readoption of this regulation isneither inconsistent nor incompatible with .any other existing .state .regulations. Theproposed readoption of the emergency regulation does not change the existingmandatory requirements on businesses subject to Proposition 65, state or localagencies and does not address compliance with any other !aw or regulation.
D. focal Mandate/Fiscal Impact
Because .Proposition 65 by its terms' does. not apply to local. agencies or school
districts, OEHHA has determined the :proposed. readoption of the emergency regulation
would not impose a mandate on local agencies or school districts., nor does it requirereimbursement by the State pursuant to Part 7 (commencing with section 1750Q) ofDivision 4 of the Government .Code.. OEHHA has also determined .that nonondiscretionary costs or savings to local agencies or school districts will result from theproposed readoption of the emergency. regulation.. Also., the .proposed readoption of theemergency regulation will not create any cost or saving to any state agency, and will .not
create any cost or savings in federal funding to the state.
E. Costs of Savings to State Agencies
Because Proposition 65 by its terms8 does not apply to any state agency and this
proposed action is simply the. extension of an .emergency regulation that provides
compliance assistance for businesses subject to the Act, ~EHHA has initially
determined that no significant savings or increased costs to any state agency will result
from the readoption of the emergency regulation.
Health and Safety Code section 25249.11(b).
$ Health and Safety Code section 25249.11(b).
4
F. Efforts to Avoid Unnecessary Duplication of Conflicts with ComparableFederal Regulations
Proposition 65 is a California law that has no federal counterpart. OEHHA hasdetermined that the readoption of the emergency regulation. does. not duplicate and willnot conflict with federal .regulations.
VIL FISCAL IMPACT
A. Costs to Local Agenc~or School District.
Because Proposition. 65 by its terms9 does not apply to local agencies or schooldistricts, OEHHA has determined the proposed readoption of the emergency regulationwould not impose a mandate on bcal agencies or school districts, nor does it requirereimbursement. by the State pursuant to Part 7 .(commencing with section .17500) ofDivision 4 of the Government Code. OEHHA has also determined that nonondiscretionary costs or .savings #o local. agencies or school. districts will result from theproposed readoption of the emergency regulation. Also, the proposed readoption of theemergency regulation .will not create any cost or saving to any state .agency, .and will notcreate any cos# or savings in federal funding to the state.
B. Cost of Savings to State Agencies
Because Proposition 65 by its terms'0 does not apply to any state agency and thisregulation is simply provides compliance .assistance. for businesses subject to the Act ,OEHHA has initially determined that no significant savings or increased costs to anystate agency will result from the proposed readoption of the. emergency regulation.
9 Health and Safety Code section 25249.11(b).to Health and Safety Code section 25249.11(b).
5
€,
SUPPLEMENTAL FINDING OF EMERGENCY FQR
EMERGENCY ACTION TO AMEND SECTION 25603.3
~;- ~~ ~ - i
The following information .supplements the "Finding of Emergency" in the Notice of
Emergency Actian filed on April 1, 2016 (OAS File 2016-0408-02E/Title 27, Amend E).
1. The emergency situation at issue here was not foreseeable in time to accomplish
it via the normal rulemaking process.
As explained. in its Notice of Emergency, OEHHA attempted to develop a
Maximum Allowable Dose Level (MADE) for oral exposure to BPA. A MADE
identifies the level of .exposure to a listed chemical that does nat require. a
warning.: Businesses often .rely on safe harbor :levels in making .decisions
whether they need to uvarn. OEHHA typically uses its safe harbor levels to
gauge the possible impact of the warning requirement for newly listed chemicals.
OEHHA determined that it could not develop a safe harbor level for oral
exposures to BPA because. of .complex scientific issues that may be resolved by
current research expected to be completed in the next one to two. years.
Once it became clear that it could not develop an .oral MADE, OEHHA
immediately began. work on this regulation. In order for the provisions of the
regulation to become effective in time. #or the May 11, 2016 warning requirement,
the regulation must be enacted through the emergency rulemaking process.
OEHHA intends to follow with a regular rulemaking process to adopt a regulation
for approximately aone-year period, which should be sufficient for an orderly
transition to more traditional warning methods and for the food industry to
transition away from use of BPA where possible.
2. Warning labels and shelf signs are not feasible in this situation.
Government Code 11342.545 defines an emergency as a "situation that calls for
immediate action to avoid serious harm to the public peace, health, safety or
general welfare." This proposed temporary regulation addresses an emergency
meeting this definition. In the absence of this regulation, businesses will take
inconsistent approaches to compliance, ranging from no warnings to ubiquitous
warnings. Inconsistent warnings on similar or even identical products would
confuse citizens on a topic of vital importance to them food.
Absent this regulation, consumers would not have. clear choices between food
and beverage products in BPA-containing and BPA-free packaging. Variations in
language. and interpretation of the warning' requirement from one retailer or
manufacturer to the next will cause more confusion than there would be if
retailers and manufacturers were permitted to temporarily employ. a uniform point
of sale warning to meet the new Proposition 65 requirements.
The. temporary regulation is needed to avert a unique situation stemming from
the fact that the BPA warning requirement will apply to a high percentage of the
canned and bottled food and beverage supply in California. There is evidence
that be#weep 66 and 90% of canned foods contain varying levels. of BPA. Given
the .long shelf life of these types of products, some of them were likely
manufactured prior to the listing of BPA in 2015. These products do not currently
carry warning labels for BPA exposures. There is a real concern that variations
in warnings on a vast array of canned .and battled foods in grocery stores
throughout the state. will. create consumer confusion. And while there is always
this risk when a new chemical gets listed, this situation is unique because of the
volume. of products that will be affected..
The only viable way to provide warnings for these products, absent the
emergency regulation, is with shelf signs. Once these older products .are na
longer in the stream of commerce, OEHHA expects many newer products
requiring warnings will .have them on the JabeL The end of the emergency
regulation and/or sunset of a temporary regulation will once again make canned
and bottled .foods. and .beverages subject to general Proposition 65 .warning
requirements. OEHHA is .not aware of any instance in the history of Proposition
65 where the effective date of a warning requirement has resulted in a similar
profusion of Proposition 65 warnings..
Placing point-of-display signs throughout a facility at each location where an
affected product is displayed would be .unworkable .given the number of .products
affected. Canned foods and beverages are located in many locations throughout
a facility and their point of display may change frequently. For example, products
currently on sale are often grouped together on endcaps or in other locations
away from the normal canned food isle. Refrigerated foods and beverages are
similarly located in different locations from the canned food aisles. Placing and
maintaining adequate signage at every point of display of a vast array of food
product is infeasible. Further, if the regulation is not enacted, each food
manufacturer, distributor and retailer would be responsible for providing a clear
and reasonable warning for their products. If each business in the supply chain
develops its own warning method .and message. content, there is a high likelihood
that they will differ substantially from each other. As noted in OEHHA's Notice,
the sudden appearance of a multitude of different warnings for food products.
throughout a store would. likely confuse consumers and cause them unnecessary
concern. Clearly, ,the situation calls fior a temporary solution that will provide the
required warning in a manner that complies with Proposition 65, but that allows
for an orderly and reasonable transition to the more typical Proposition 65
warning regimen.
3. Providing an opportunity for a retailer to repost or replace a sign. that has
~- inadvertently-been removed-or--otherwise-dar~aaged-within 2~-hours of notification --
ordiscovery is not beyond OEHHA's authority and. is needed in order to ensure
that the .proposed warning program for BPA works smoothly and to avoid
frivolous enforcement actions. It is foreseeable that a warning sign posted in a
high-traffic area within a retail facility, ar on a vending machine, might fall down
or be damaged from time to .time.. Most facilities wiN have the sign ..posted in
more than one location, so the absence of the sign from a single check-out line
will not likely result in the complete absence of signage. Conversely, the need
for retailers #o have multiple point-of-sale signs increases the. likelihood that a
sign might fall down or be damaged. Providing an opportunity for a retailer who
is complying with the. regulation to correct an inadvertent error of #his type will not
encourage blatant violations of .law, but will curtail filing of frivolous lawsuits for a
brief absence of the. required signage.
Further, the proposed regulation would. put specific requirements in place to
ensure that the retailer practices due diligence in posting and maintaining the
required. signage. This includes provisions that require the .retailer to practice
normal quality control and. maintenance procedures to ensure the signage is in
place and maintained properly in the same manner as other signage or
maintenance requirements for the facility. Lastly, the provision includes a
limitation that the error must be corrected within 24 hours of discovery or
notification, again to help ensure that the problem is corrected promptly, thus
furthering the. purposes of the Act by ensuring the signage is available to the
consumer prior to purchase of products containing BPA.
4. Additional documents relied on:
a. Noonan GO, Ackerman LK, Begley TH (2011). Concentration of bisphenol
A in highly consumed canned foods on the U.S. market. J Agric Food
Chem. 13;59(13):7178-85.
b. "BFA Buyer Aware"; a report by: Breast Cancer Fund, Campaign for
Healthier Solutions, Clean Production Action, Ecobgy Center, Mind the
Store Campaign, published March 2x16. Available online at:
http://www, breastcancerfund.or~/assets/pdfs/publications/buyer-beware-
report.pdf)
c. Lorber M, Schecter A, Paepke O, Shropshire. W, Christensen K, Birnbaum
L (2015). Exposure assessment of adult intake of bisphenol A (BPA) with
emphasis on canned food dietary exposures. Environment International,
77, 55-62. http:l/doi.org/10.1016/j.envint.2015.Q1.008
d. Journal of Agriculture and Food Chemistry article "Concentration of
Bisphenol A in Highly Consumed Canned Foods an the U.S. Market" J.
Agric. Food. Chem., 2011, 59, 7178-7185
4
! ` ! i ••3 f is l;
NOTICE OF EMERGENCY ACTION
EMERGENCY ACTION TO AMEND. SECTION 25603.3
TITLE 27, CALIFORNIA CODE OF REGULATIONS
WARNINGS FOR EXPOSURES TO BISPHENOLA
FROM CANNED AND BOTTLED FOODS AND BEVERAGES
April 1, 2tJ16
.~~ ~ ,
The Office of Environmental Health Hazard Assessment (OEHHA) is the state entity
responsible for the implementation of Proposition 65.' OEHHA has the authority to
adopt .and. amend regulations to .implement and further the purposes of Proposition 65.
(JEHHA maintains a list of chemicals known to cause reproductive toxicity or cancer.
Proposition 65 requires businesses to provide. a warning when they knowingly and
intentionally cause an exposure to a listed chemical, and .prohibits the discharge of
listed chemicals into sources of drinking water.
The current safe. harbor warning regulations adopted by OEHHA in Title 27 of the
California. Code of Regulations, section 25601, provide general guidance concerning. the
types of warning methods and. content that are deemed "clear and. reasonable" for
purposes of the. Act.
On May 11, 2015, bisphenol A (BPA) was added to the Proposition 652 list of chemicals
known to cause reproductive toxicity. Effective May 11, 2016, warnings are required for
1 The Safe Drinking Water and Toxic Enforcement Act of 1986, codified at Health and Safety Code section 25249.5
et seq., commonly referred to as "Proposition 65".
Z http://oehha.ca.~ov/prop65/CRNR notices/list changes/0511151istBPA.html
0
exposures to BPA unless the person causing the exposure can show-that an exposure
1,000 times the level in question has no observable effect.3 OEHHA is proposing to
promulgate an emergency regulation to allow temporary use of a standard point-of-sale
warning message. for BPA exposures from canned and bottled foods and beverages.4
II. BACKGROUND
A. Proposition 65
Proposition 65 passed by citizen initiative with 63 percent of the popular vote. In part,the statute says:
"No person in the course of doing business shall .knowingly and intentionally
expose any individual to a chemical known to the state to cause cancer or
reproductive toxicity without first giving a clear and reasonable warning... "5
Proposition 65 is a right-to-know law based on the concept that members of the public
have a right to know when they are being exposed to listed carcinogens or reproductive
toxicants. A Proposition 65 warning is not a regulatory decision that a product is safe. or
unsafe. Rather, the law is designed to help consumers decide whether to assume the
risks of purchasing particular products that result in exposures to listed. chemicals.
B. The warning requirement for BPA begins on May 11, 2016
On .May 11, 2015, bisphenol A (BPA) was. added to the. Proposition 65 .list of .chemicals
known to the state to .cause reproductive toxicity based. on the female. reproductive
endpoints Female reproductive toxicity occurs when a chemical damages any aspect
of the female reproductive system. BPA is commonly used in certain linings of metal
cans and lids of glass bottles containing food and beverages. Under Proposition 65,
one year .after. the listing, beginning May 11, 20.16, warnings. are required for all
exposures to BPA unless the. person causing the exposure can show that. the exposure
when multiplied by 1,000 times has no observable effect.'
C. Businesses make the decision whether to provide a warning and have options
for the content of the warnings.
3 Health and Safety Code, sections 25249.10(b), 25249.10(c)
4 In a separate rulemaking process, OEHHA is proposing a Maximum Allowable Dose Level (MADE} that establishes
a level of dermal exposure to BPA that does not require a warning. The MADL is unrelated to this rulemaking
package because exposures from canned and bottled foods and beverages are not dermal exposures.
5 Health and Safety Code, section 25249.6
6 htto://oehha.ca.~ovlprop65/CRNR notices/list chan~es10511151istBPA.html_
Health and Safety Code sections 25249.10(b), 25249.10(c)
2
A product does not require a warning simply because it contains a chemical that is listedunder Proposition 65. A warning is required only when a business knowingly andintentionally causes an exposure to a listed chemical. The business that is responsiblefor the product must make several decisions:
First, the business should determine whether its products are likely to .expose
individuals to .any listed. chemicals.
Second, if the product causes an exposure to a listed chemical, the business should
determine whether OEHHA has identified a regulatory safe harbor level for thechemical. An .exposure below. a safe harbor level (for reproductive toxicants, also
known as a Maximum. Allowable Dose Level, or MADE) is exempt from the warning
requirement.$
Third, if there is no regulatory safeharbor level for a listed reproductive toxicant, a
business that knowingly exposes individuals to that chemical is generally required to
provide a Proposition 65 .warning, unless the .business can .show that the exposure to
the chemical, when multiplied by 1,000., has no observable effect. Determining this
threshold .level for,the chemical and the exposure caused by the product can be
complex.
Fourth, if a business decides that a warning is required, OEHHA's safe harbor
regulations on warnings allow. the business. several options.10 A business may provide
the warning on a product's label, shelf tags, shelf signs, menus or any combination
thereof as long as the. warning is prominent and conspicuous." OEHHA regulations
also provide for a general safe harbor warning for consumer products; including food,
that states: "This product contains a chemical known to the State of California to cause
birth defects or other reproductive harm."12 Thus, there. is currently no statutory or
regulatory requirement for a Proposition 65 warning to actually identify the. chemical at
issue.. Also, the current regulation does not expressly allow for point-of-sale warnings
for consumer products that cause exposures to .listed chemicals.
$ Health and Safety Code sections 25249.10(c}, Title 27, Cal. Code of Regs., section 25801, et seq.
9 Health and Safety Code sections 25249.10{c)to Title 27, California Code of Regulations, section 2560111 Title 27, California Code of Regulations, sections 25603 and 25603.1.12 Title 27, Code of Regulations, Section 25603.2
D. Maximum Aliawable Dose Levels can clarify when a warning is required but
none exists for oral exposure to BPA at this time
Because Proposition 65 .requires .businesses, rather than OEHHA, to determine when
warnings are required, some businesses may make their own determination that the
BPA exposures that they are causing are too low to require a warning, even though the
BPA exposures. from their. productsmay be comparable to, or even greater than,
exposures from other products that carry warnings. OEHHA generally tries to avoid
such. situations by establishing MADLs. Businesses over the years have relied on
MADLs and related guidance in determining when they need to provide warnings..
Unfortunately, there is currently no MADL for oral exposure from food. and beverages to
BPA.13 OEHHA is waiting far research sponsored by the federal government that may
resolve complicated scientific. questions that. would .enable OEHHA to establish a MADL
for BPA oral exposures.. The research is expected to be completed in .late 2017 or early
2018.
E. The Attorney General, local~rosecutors, and private litigants enforce
Proposition 65 through litigation, which can result in civil penalties and other
sanctions
Proposition 65 is enforced through civil lawsuits brought by the California Attorney
General, or by a district attorney or city attorney of a city with a population .exceeding
750,000. Private parkies may also bring Proposition 65 lawsuits.14 If a business is
found to be in violation of Proposition. 65, a court .may order. the business to stop
committing the violation...The business is also subject to civilpenalties of up to $2,500
per day for each violation.
F. Many canned and bottled food and beverages sold throughout California are
likely to require warning
The. listing of BPA under. Proposition 65 will have widespread. impacts on food and
beverages sold .across the state.. BPA is used to make epoxy resins, which act as a
protective lining on the inside of many (though not all) metal-based food and beverage
cans and an lids for glass jars and bottles.15 It is approved by the U.S. Food and Drug
Administration (FDA) for use in food-contact applications including food and. beverage
13 OEHHA is developing a MADL for dermal (skin) exposure. See footnote 2, above.14 Health and Safety Code, section 25249.7(d)is http:/jwww.fda.govJfood/ingredientspackaginglabeling/foodadditivesingredients/ucm064437.htm
can linings and seals, except for baby formula.'6 Many canned and bottled food and
beverages can cause exposures to varying amounts of BPA."
Currently, these canned and bottled foods and beverages do not carry Proposition 65
warnings because no warning is required for BPA exposures. until May 11, 2016.
OEHHA understands that some canned food and beverage manufacturers plan to
reduce or eliminate the use. of BPA, or have recently done so, and the need for
warnings for these. products will. likely decrease over time. Any changes .made by
manufacturers will not immediately affect. existing retail inventories, however, because
many canned foods and beverages. have a shelf life of up to three years. Thus,
although businesses. have .had a .year. to remove or reduce. BPA from their products,
many products produced prior to or immediately after the May 2015 listing of BPA are
still in the stream of commerce and will require warnings beginning in May 2016.
G. Emergency action is needed
Given this situation, OEHHA is concerned that businesses will take inconsistent ,
approaches to compliance, particularly in the time. period immediately following May 11,
when the warning requirement. begins. For example;
Products that contain relatively high amounts of BPA may have. no warning at all.
In the absence of a MADL, businesses must decide. on their own .whether. the
BPA exposures their products cause are. high enough to trigger the. warning
requirement..This is a complex decision. by individual businesses that involves
not only scientific interpretation of the. health effects of BPA, but also the use of
the business'. own information on the frequency. that consumers use their
products and. how much they consume. Some .businesses may decide that
products causing relatively high exposures to BPA do not require warnings, while
others decide to place warnings. on products causing Tower exposures to BPA.
Consumers will have no immediate way of distinguishing between them. Some
may incorrectly assume that a productwith. no warning has no BPA.
• Some retailers may put warnings on all products with BPA, while others warn
se%ctively. Consumers could .see. a warning for a product in one store, and no
warning for the same products in another. Ubiquitous warnings may undermine
16 Title 21, Code of Federal Regulations, section175.300
1' See, e.g., and Lorber, M., Schecter, A., Paepke, O., Shropshire, W., Christensen, K., and Birnbaum, L. (2015).
Exposure assessment of adult intake of bisphenol A (BPA) with emphasis on canned food dietary exposures.
Environment International, 77, 55-62. http:/Jdoi.ark/10.10161j.envint.2015.01.008 and Journal of Agriculture and
Food Chemistry article "Concentration of Bisphenol A in Highly Consumed Canned Foods on the U.S. Market" J.
Agric. Food Chem., 2011, 59, 7178-7185
5
the effectiveness of Proposition 65, as some consumers are alarmed by them
and others disregard them as meaningless and uninformative.
Under the current Proposition fi5 warning regulation, the most .likely way far
businesses to ensure. pre-May 2015 canned and bottled food and beverage
products have warnings is for retailers to post shelf signs with warnings for each
individual canned and bottled food product that may require a warning. Until. pre-
May 2015 products are no longer in the stream of commerce, it is likely that most
retailers would have a plethora of warning signs wherever canned and bottled
food and beverage products are displayed in their stores. The relatively sudden
appearance of a large number of warning signs referring to a multitude of food
and beverage ..products is likely to confuse. and overwhelm consumers.. Some
consumers .might. become overly alarmed, while. many consumers would dismiss
them as uninformative. Neither outcome furthers the purposes. of Proposition 65.
• Currently there is no statutory or regulatory requirement for Proposition 65
warnings to name. the chemical of concern or the health effect associated .with it.
While .some businesses may choose to name BPA and. provide. supplemental
information about it in its ,warning, OEHHA anticipates that most warnings will
simply say the food or beverage product "contains a chemical. known to the .State
of California #o cause birth. defects or other reproductive harm." Consumers
seeing these. warnings will not. know what chemical they are .being warned about
or how they could reduce their exposure to it. While this .has been the. case with
the majority of Proposition 65 warnings over the years, the multitude of warnings
for foods and beverages combined with a lack of information creates a uniquely.
high potential for confusion that does not serve the .public interest and should be
avoided.
Rather than address these problems, OEHHA could do nothing and simply assume that
enforcement actions will. eventually resolve .uncertainty about what .products. require
warnings and the adequacy of the warnings.. But litigation will not provide clear
guidance for businesses attempting to prepare. for May 11. Nar will it help. consumers
and businesses faced with :these problems in the period immediately following May 11.
The. proposed emergency regulation will provide a reasonable transition period to help
avoid consumer confusion and at the same time provide consistent, informative, and
meaningful warnings to consumers about significant exposures to BPA. The proposed
safe harbor warning for canned. and bottled foods .and. beverages will identify BPA by
name, and disclose .that it causes harm to the female. reproductive system. The
warnings will also provide the public with supplemental information via a link to
OEHHA's website, which will contain fact sheets and links to informational materials on
[~
BPA from other authoritative organizations. Moreover, because it will be limited in
duration, businesses that have not already switched to safe alternatives will have astrong incentive to do so before the regulation expires. At that time, OEHHA will
attempt to have completed a MADL so that businesses have guidance an the amount of
BPA exposure that does not require a warning under Proposition 65.
OEHHA views this emergency regulation as addressing a unique situation. This
emergency regulation should not be used as a precedent for future regulatory actions.
111. FINDING OF AN EMERGENCY
A. Section 48 Statement
Title 1 of the California Code of Regulations, section 48 requires the following
statement:
"Government Code. section 11346.1. (a)(2) requires that, at least five working
days prior to submission of the proposed emergency action to the Office of
Administrative Law, the adopting agency provide a notice. of proposed
emergency action to every person who. has filed a request for notice of regulatory
action with the agency. After submission of the of the proposed emergency to
the .Office of Administrative .Law, .the Office of Administrative. Law shall allow
interested persgns five calendar days to submit comments. on .the. proposed
emergency regulations as set forth in Government Code section 11349.6."
B. Facts Constituting the Need for an Emergency Action
The APA defines an "emergency° to mean "a situation that calls. for immediate .action to
avoid .serious harm. #o the .public peace, health, safety, or .general welfare.° (Gov..Code
section 11342.545.) To make a finding of emergency, the agencymustdescribe the
specific facts supported by substantial evidence that demonstrate the existence of an
emergency and the need for immediate adoption of the proposed regulation. (Gov.
Code section 11346.1(b)(2).) Some factors an .agency may consider in determining
whether an emergency exists include: (1) the magnitude of the potential harm, (2) the
existence of a crisis situation, (3) the immediacy of the need, i.e., whether there is a
substantial :likelihood that serious harm will be experienced unless immediate action is
taken., and. (4) whether the anticipation of harm has a basis firmer than simple
speculation. Pursuant to these statutes, OEHHA #finds that an emergency exists in the
present case.
An emergency exists because,, if this regulation is not in place by May 11, 2016,
consumers will see inconsistent health warnings on canned and bottled food and
beverages throughout the state. This situation would cause widespread confusion and
undermine the purpose of Proposition 65.
The following facts support this finding:
• BPA is commonly found in the linings of cans, and jar and battle lids, for food and
beverage products that are sold throughout California.
• BPA can move into the food or beverage from the linings and lids of cans and
bottles..
• Because canned and bottled foods have shelf lives of up to three years, there are
large inventories of canned and. bottled food products currently on store shelves.
• Proposition 65 warnings for BPA are not provided on the cans, bottles or jars that
are already in commerce. OEHHA anticipates that retailers will post multiple
warning signs where canned and bottled foods and beverages are displayed,
resulting in a plethora of warnings that will confuse consumers.
• Consumers determined to navigate through the maze of warnings may identify
and buy products that do not have a warning under the mistaken belief that they
do not contain BPA. This is because somebusinesses may choose not to
provide warnings. because they believe the BPA exposures they are causing are
below the level required for Proposition 65 warnings, even though other
businesses causing comparable or lower. exposures are providing Proposition 65
warnings for their products. These. inconsistencies in the marketplace are likely
to thwart the informational purposes of Proposition 65.
• OEHHA generally tries to provide MADLs and related guidance to businesses to
avoid such situations, .but is unable to do so at this time because of complicated
scientific .questions involved in identifying a No Observable.. Effect Level. for BPA,
which. is the key step in .calculating the MADL.
o A temporary, uniform point-of-sale warning would help avoid public confusion
that could result from. inconsistent warning messages about these products.
~EHHA believes that pending research .may inform the development of an oral
MADL and other guidance to address inconsistent warnings.. The. proposed. safe
harbor warning for BPA in canned and bottled foods and beverages is intended
to provide an orderly transition to consistent, product-specific warnings.
• The proposed .regulation will provide the. public with supplemental information via
a link to the OEHHA website, which will contain fact sheets and links to materials
from other. authoritative organizations concerning exposures to BPA from canned
and bottled foods and beverages to help consumers make informed decisions.
Under the current regulations, businesses could lawfully provide general
warnings that do not even identify BPA as the chemical of concern and that do
not provide a link to the OEHHA website.
E3
• The short duration of the regulation, and the consumer awareness of BPA that itwould promote, would motivate businesses to reduce or eliminate BPA from theirproducts if they have not already done sa.
• Action is necessary to ensure an effective transition from the sale of canned andbottled floods without Proposition 65 warnings to providing consistent warningsfor significant BPR exposures from these food products and reformulation. ofproducts. with safe alternatives where feasible..
OEHHA attempted to address the emergency situation through nan-emergency
regulations, but encountered technical and practical .problems with that approach. Asstated above, OEHHA attempted to develop a MADE for oral exposure that would havebeen enacted through the normal regulatory process. In the course of that .process,
C?EHNA scientists found that the issue was technically complex and additional research
is needed. However, the federal government is currently sponsoring a :large series of
studies intended to clarify the effects of BPA at low doses.18 Some of these studies,
expected to be complete in 2017 or 2018, could. inform the development of an oral.
MADL that will provide clarity for consumers and businesses. Rs the May 11, 2016.
deadline for warnings has approached, ~EHHA also became concerned that some.
manufacturers and retailers. will take the kind of inconsistent approaches discussed
above. Accordingly, OEHHA developed this temporary regulation to mitigate .potential
harm and .confusion for consumers.
OEHHA has concluded that. both. the ..public and the food and beverage .businesses
would benefit #rom the clarity that a uniform :point-of-.sale warning regulation would
provide. The proposed emergency regulation would expire after 180 days. During that
period, OEHHA will commence a regular rulemakin~ process to adopt a regulation as
an interim measure for aone-year period from date of adoption. This time period..
should be .sufficient to ensure an orderly #ransition to providing. more product.-specific
warnings for BPA exposures, and for .more. manufacturers to reduce or eliminate
exposures to BPA by switching to safer alternatives where feasible. It will also allow
additional time for OEHHA to evaluate the emerging science that, if sufficient, would
support a MADL for oral exposures to BPA, which would.. further clarify which products
require a warning.
18Birnbaum LS, Bucher JR, Coltman GW, Zeldin DC, Johnson AF, Schug TT, Heindel
JJ (2012). Consortium-based science: the NIEHS's multipronged, collaborative approach to
assessing the health effects of bisphenol, Environmental Health Perspectives, 120(12):1640-4. Available at:
http:/{ehp.niehs.nih~*~ov/1205331 Heindel J1, Newbold RR, Bucher 1R, Camacho L, Delclos KB, Lewis SM,
Vanlandingham M, Churchwell MI, Twaddle NC, Mc~ellen M, Chidambaram M, Bryant M, Woodling K, Gamboa da
Costa G, Ferguson SA, Flaws J, Howard PC, Walker NJ, Zoeller RT, Fostel J, Favaro C, Schug TT (2015). NIEHS/FDA
CLARITY-BPA research program update. Reproductive Toxicology, 58:33-44. See also
http://www.niehs.nih.gov/research/programs/endocrine/bpa_initiativeslbpa-related/index.cfm
9
~'
C. Need for the Proposed Regulation to Effectuate the Statute
Proposition 65 was enacted to protect the public from exposures to chemicals thatcause cancer, birth defects, or reproductive harm`by informing the public about
exposures to these chemicals. As is discussed above, this proposed emergencyregulation is necessary to avoid potential consumer confusion and dilution of theeffectiveness of Proposition 65 warnings to the. public that could result from inconsistentmessages.
IV. TECHNICAL, THEORETICAL, AND/OR .EMPIRICAL STUDY, REPORTS, OR
DOCUMENTS RELIED UPON
Citations to documents relied on for this proposal are provided in this document. No
other technical, theoretical or empirical material. was relied upon by OEHHA in
proposing the adoption of this regulation..
V. AUTHORITY
Health and Safety Code section 25249.12(a)
VI. INFORMATIVE DIGEST
A. Backaround tsee Section II. above
B. Specific Benefits of the Proposed Regulations
This regulatory proposal is intended to further the purposes of Proposition 65 by
encouraging the use of a consistent and informative point-of-sale warning message for
BPA exposures from canned and .bottled foods and beverages. (See. Sections 11 and III,
above.)
C. No InconsistencX or Incompatibility with Existing Regulations
OEHHA has conducted an evaluation and has determined that this would be the only
regulation concerning Proposition 65 BPA warnings. Therefore, the proposed.
regulation is neither inconsistent nor incompatible. with any other existing state
regulations. The proposed regulation does not change the existing mandatory
requirements on businesses subject to Proposition 65, state or local agencies and does
not address compliance with any other law or regulation.
m
D. Local Mandate/Fiscal Impact
Because Proposition 65 by its terms19 does not apply to local agencies ar school
districts, OEHHA has determined the proposed regulatory action would not impose amandate on local agencies or school districts, nor does it require reimbursement by theState pursuant to Part 7 (commencing with section 17500) of Division 4 of theGovernment Code. OEHHA has also .determined. that no nondiscretionary costs or
savings to local agencies or school districts will result from the proposed regulatory
action. Also, the proposed action will not create any cost or saving to any state. agency,and .will not create any cost or savings in federal funding to the. state.
E. Gosts of Savings to State Agencies
Because Proposition 65 by its terms20 does not apply to any state agency and this
regulation is simply. a clarification of existing procedures, OEHHA has initially
determined that no significant savings or increased costs to any state agency will result.
from theproposedregulatory action.
F. Efforts to Avoid Unnecessary Duplication of Conflicts with Comparable
Federal Regulations
Proposition 65 is a California law that has no federal counterpart. OEHHA has
determined that the regulations do not. duplicate .and will not conflict with federal
regulations.
VII. FISCAL IMPACT
A. Costs to Local Agency or School District
Because Proposition 65 by its terms2' does not apply to Local agencies or school
districts, OEHHA has. determined the proposed regulatory action would not impose a
mandate on Jocal agencies or school districts, nor does it require reimbursement by the
State pursuant to Part 7 (commencing with section 17500) of Division 4 of the
Government Code. OEHHA has also determined that no nondiscretionary costs or
savings to local agencies or school districts will result from the proposed regulatory
action. Also, the proposed action will not create any cost or saving to any state agency,
and will not create any cost or savings in federal funding to the state.
19 Health and Safety Code section 25249.11(b).
20 Health and Safety Code section 25249.11(b).zl Health and Safety Code section 25249.11(b).
11
B. Cost of Savings to State Agencies
Because Proposition 65 by its terms22 does not apply to any state agency and thisregulation is simply a clarification of existing procedures, OEHHA has initially
determined that no significant savings ar increased costs to any state agency will result
from the proposed regulatory action.
ZZ Health and Safety Code section 25249.11(b).
12