INITIAL STATEMENT OF REASONS

Initial Statement of Reasons

Title 27, California Code of Regulations

Proposed Amendments to Article 6

Clear and Reasonable Warnings:

Short-Form Warnings for Consumer Product Exposures

January 2021

California Environmental Protection Agency

Office of Environmental Health Hazard Assessment

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

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Table of Contents

Summary .................................................................................................................... 3

Background/Problem to be Addressed by the Proposed Rulemaking ........................... 4

Proposed Amendments ............................................................................................... 8

§ 25601 Safe Harbor Clear and Reasonable Warnings – Methods and Content ............ 8

Subsection (b) ............................................................................................................. 8

§ 25602. Consumer Product Exposure Warnings – Methods of Transmission. ............. 8

Subsection (a).............................................................................................................. 8

Subsections (b) and (c) ................................................................................................ 9

Subsection (e) ........................................................................................................... 10

§ 25603. Consumer Product Exposure Warnings – Content. ....................................... 11

Subsection (a)............................................................................................................ 11

Subsection (b) ........................................................................................................... 11

Subsections (c) and (d) .............................................................................................. 12

§ 25607.2. Food Exposure Warnings – Content. .......................................................... 13

Subsection (a)............................................................................................................ 13

Subsection (b) ........................................................................................................... 13

Necessity .................................................................................................................. 15

Benefits of the Proposed Regulation ......................................................................... 15

Technical, Theoretical, and/or Empirical Study, Reports, or Documents Relied Upon . 15

Reasonable Alternatives to the Regulation and the Agency’s Reasons for Rejecting

Those Alternatives .................................................................................................... 15

Reasonable Alternatives to the Proposed Regulatory Action that Would Lessen Any

Adverse Impact on Small Business and the Agency’s Reasons for Rejecting Those

Alternatives .............................................................................................................. 16

Evidence Supporting Finding of No Significant Adverse Economic Impact on Business 16

Efforts to Avoid Unnecessary Duplication or Conflicts with Federal Regulations

Contained in the Code of Federal Regulations Addressing the Same Issues ................ 16

Economic Impact Assessment Required by Gov. Code section 11346.3(b) .................. 17

Creation or Elimination of Jobs within the State of California ................................. 17

Creation of New Businesses or Elimination or Expansion of Existing Businesses

within the State of California .................................................................................... 17

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Benefits of the Proposed Regulation to the Health and Welfare of California

Residents, Worker Safety, and the State’s Environment ......................................... 17

Appendix A – Examples of Actual Short-Form Warnings ............................................ 18

Appendix B - Examples of Short-form Warnings Compliant with the Proposed

Amended Regulations on 5 sq. in Product Surface Area* ........................................... 21

Short-form warning on 5” x 1” product surface area ................................................... 21

Short-form warning on 3” x 1.75” Product Surface Area .............................................. 22

Short-form warning on 2.5” x 2” Product Surface Area ................................................ 23

Summary

Proposition 65

requires businesses to provide a clear and reasonable warning

before they knowingly and intentionally cause an exposure to a chemical listed

as known to the state to cause cancer or reproductive toxicity. In August 2016,

the Office of Environmental Health Hazard Assessment (OEHHA) adopted major

changes to the “Clear and Reasonable” safe harbor warning regulations (Title 27

of the California Code of Regulations, Article 6), originally adopted more than 30

years ago. The primary purpose of the rulemaking was to provide consumers

with more specific information about the chemicals they are exposed to, and to

point them to a newly constructed OEHHA warnings website for further

to those concerns, OEHHA included the option to provide a “short-form” warning

on a product label. An example of a short-form warning is the following:

WARNING: Cancer and Reproductive Harm -

www.P65Warnings.ca.gov.

Implementation of the warning regulations has revealed the need for express

limits on the use of the short-form warning for consumer products. The regulation

did not limit application of the short-form warning to a maximum label surface

area. While OEHHA intended for this warning option to only be used for small

products or containers with insufficient space for the longer warning, businesses

have used the short form warning on a wide range of consumer products that

have more than enough label space for the longer warning. Just as concerning,

the short-form warning is also being placed on some products even when the

Health and Safety Code Section 25249.5 et seq., The Safe Drinking Water and Toxic

Enforcement Act of 1986, commonly known as “Proposition 65”. Hereafter referred to as

“Proposition 65” or “the Act”.

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business has no knowledge of an exposure to a listed chemical requiring a

Proposition 65 warning.

This rulemaking would amend the safe harbor warning regulations to improve the

short-form warnings by communicating additional information about chemical

exposures to consumers including the chemical name, so the consumer can

obtain more specific information about it on the OEHHA website. The rulemaking

would expressly modify the existing short-form warning provisions as follows:

· Only allow use of the short-form warning on products with 5 square inches

or less of label space.

· Eliminate use of short-form warnings for internet and catalog warnings.

· Clarify how short-form warnings can be used for food products.

· Require that the name of at least one chemical be included in the short-

form warning.

For businesses that choose to use the modified short-form warning, the proposed

regulation provides a one-year phase-in period for existing products to allow a

smooth transition to the modified warning. Further, the proposed regulation

provides an unlimited sell-through period for products that had compliant

warnings when they were manufactured, thus allowing businesses to avoid

recalling items in the stream of commerce to apply the modified short-form

warning.

An example of the proposed short-form warning is the following:

WARNING: Cancer Risk From Formaldehyde and Reproductive Risk

From Toluene Exposure - www.P65Warnings.ca.gov.

Without these changes, use of the short-form warning will continue to be

inconsistent with the intent of the Act and OEHHA’s intent in adopting the 2016

regulations — that warnings communicate meaningful information about

chemical exposures to consumers, and that short-form warnings be used only

on labels for small products that cannot accommodate the full-length warning

content described in Section 25603(a)

Background/Problem to be Addressed by the Proposed

Rulemaking

OEHHA seeks to address in this regulatory proposal the following primary

concerns with the current uses of the short-form warnings: 1) Businesses are not

required to identify a chemical or chemicals in the short-form warning, which

significantly limits the usefulness of the warnings to consumers, 2) Businesses

Article 6 Clear and Reasonable Warnings, Initial Statement of Reasons (2015), p.31.

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use the short-form warning for products that can easily accommodate a longer

warning, and 3) Businesses use the short-form warning prophylactically when no

warning is required.

OEHHA explained its intent regarding use of short-form warnings in the Initial

Statement of Reasons (ISOR)

and Final Statement of Reasons (FSOR)

for the

2016 rulemaking:

Subsection (b) sets out a specific short version of the warning that may

only be used for on-product warnings. This provision proposes a very

limited level of content to be included in an on-product warning to

accommodate some product manufacturers’ stated concern that a longer

warning message will simply not fit on the labeling or packaging of some

small products. OEHHA is proposing a label that strikes a balance

between this concern and the requirement in the statute that a person

receive a warning prior to exposure. OEHHA believes that this approach

will provide useful information to individuals while avoiding unwieldy on-

product warnings. Further, the warning is clearer and more direct than the

existing safe harbor warnings being used by many businesses.

Recognizing the potentially limited space available for a warning, under

subsection (c) the name of the listed chemical being warned for is not

required.

(emphasis added)

After OEHHA adopted the Article 6 regulations in August 2016, OEHHA

discovered that many businesses were using the short-form warning for all kinds

of consumer products, regardless of product size. OEHHA also did not anticipate

the widespread use of short-form warnings for food products but received

numerous inquiries from businesses seeking clarification as to how and whether

the short-form warning could be used as a safe harbor warning for food products.

Further, OEHHA determined that many businesses are using the short-form

warning because it protects them from potential litigation without requiring them

to name a specific chemical exposure. As a result, these businesses likely have

provided warnings for exposures that do not or cannot occur from use of their

products.

OEHHA frequently receives inquiries from the public regarding exposures from a

Article 6 Clear and Reasonable Warnings Regulations, Initial Statement of Reasons

(2015), available at

https://oehha.ca.gov/media/downloads/crnr/112715warningreg20isor.pdf (last accessed

May 15, 2020).

Article 6 Clear and Reasonable Warnings Regulations, Final Statement of Reasons

(2016), available at https://oehha.ca.gov/media/downloads/crnr/art6fsor090116.pdf (last

accessed May 15, 2020).

Article 6 Initial Statement of Reasons (2015), supra note 3.

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wide range of consumer products labeled with a short-form warning. An informal

tally of public inquiries to OEHHA related to Proposition 65 warnings during

December 2019 through December 2020, nearly 70% of consumer inquiries

requested more information about a specific product, and at least 18% of

consumer inquiries included a request for information regarding a short-form

consumer product exposure warning. These consumers wanted to know the

name of the chemical to which they might be exposed.

As an example, during the current COVID-19 emergency, OEHHA has received

multiple inquiries from members of the public concerning short-form warnings

provided on HEPA vacuum filters because consumers were using the filters in

home-made face masks. Consumers wanted information regarding the

chemical(s) for which the businesses were providing a warning, so that they

could make an informed decision whether to use the product.

Further, while a short-form warning may be appropriate for a small item such as

specialty adhesives in very small tubes or similar products where label space is

very limited, short-form warnings have been provided on a wide range of

consumer products which do not have such constraints. For example, many

manufacturers are providing short-form warnings on large appliances such as

refrigerators, ranges, washers, and dryers; as well as on miscellaneous

consumer products such as backpack leaf blowers, guitars, nursery plant

containers, luggage, and vacuum cleaners.

6,7

There is no reason to use short-

form warnings for such products. There is ample space on the packages of these

products for businesses to provide warnings that name a chemical or chemicals

so consumers know they can be exposed to those chemicals through use of the

product.

To address these types of issues and obtain information for the public regarding

consumer exposures to listed chemicals, OEHHA sent 17 letters during 2019-

2020 to businesses providing short-form warnings requesting chemical exposure

information for the Proposition 65 Warnings Website

(http:www.p65warnings.ca.gov) as allowed by Section 25205 of the regulations.

OEHHA received limited chemical exposure information from some businesses;

other companies failed to respond to OEHHA’s request for information. Most did

not identify an exposure that likely needed a warning.

For example, a manufacturer of appliances displaying short-form warnings

See Appendix A for examples of actual short-form warnings in use on consumer

products.

In one instance, a hunting, shooting, and fishing retailer posted short-form warnings for

cancer and reproductive toxicity at the front entrance of one of their retail locations.

Such a warning clearly does not comply with the safe harbor requirements of Article 6.

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stated,

“…due to the complexity of the appliances we manufacture, many of the

components are located within interior parts of our appliances, and thus,

the average consumer may not ever be exposed to the listed chemicals.

Despite this, [manufacturer] chooses to include the Proposition 65 warning

out of an abundance of caution.”

A guitar manufacturer replied,

“…two chemicals were listed as ingredients in paint … that is applied on to

some guitars … that under normal use conditions … [manufacturer] does

not anticipate that its guitars would expose a customer to these chemicals,

but that the warnings were provided out of an abundance of caution.”

Some consumers have informed OEHHA of instances where a business

representative told them that they are required to provide a Proposition 65

warning for all products sold in California but when asked would not provide the

name of the listed chemical that the warning was provided for, because the

business is not required to do so, because such information is “confidential”, or

the specific chemical name is unknown. These practices are contrary to the

statutory requirement to give clear and reasonable warnings for exposures to

listed chemicals, and OEHHA’s stated intention in the 2016 rulemaking to provide

more meaningful and informative warnings for consumer product exposures.

The current short-form warning facilitates such “over-warning” by providing

businesses with safe harbor protection from enforcement actions without

requiring the business to provide sufficient information to consumers. The

warning includes the address of OEHHA’s Proposition 65 warnings website, but

the sheer number and variety of products with short-form warnings have made it

impossible for OEHHA to obtain and post information about many of these

products on its website. Thus, consumers must contact the manufacturer or

seller of the product to try to determine why they are being warned, and what the

warning means.

After carefully assessing businesses’ use of the short-form warning since the

regulations were adopted in 2016,

OEHHA has determined that changes to the

regulations are necessary. Without these proposed changes, use of the short-

form warning will continue to result in many warnings being inconsistent with the

intent of the Act, OEHHA’s intent in adopting the 2016 regulations, and its stated

intent for adopting the short-form warning

The revised Article 6 Clear and Reasonable Warnings regulations were adopted on

August 30, 2016 and became operative on August 30, 2018.

Article 6 ISOR (2015), supra note 3.

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Based on OEHHA’s experience with the current short-form warning, OEHHA has

determined that, in order for a business to obtain safe harbor protection,

consumer product warnings must include the name of at least one listed

chemical to which the consumer may be exposed. While OEHHA still

acknowledges the need for product warnings on very small packages, OEHHA

does not believe the small size of a package justifies the failure to include any

chemical-exposure information. Further, OEHHA anticipates that some

businesses may stop the practice of over-warning as a strategy to receive safe

harbor protection if they must warn customers of a specific chemical exposure

that can occur through use of their product. A reduction in over-warning furthers

the purposes of the Act by reducing the unnecessary proliferation of Proposition

65 warnings where a chemical exposure is unlikely to occur and ensuring that

consumers are provided with truthful, accurate information about anticipated

exposures to listed chemicals from consumer products where they can occur.

Each of the proposed amendments to the warning regulations is discussed

below.

Proposed Amendments

§ 25601 Safe Harbor Clear and Reasonable Warnings – Methods and

Content

Subsection (b)

The phrase, “Except as provided in Section 25603(c),” would be deleted, along

with Section 25603(c). Section 25603(c) currently provides that a short-form

consumer product exposure warning does not require the name of a listed

chemical. By removing Section 25603(c), the proposed amendments to Section

25603, discussed in detail below, would require a business to provide the name

of one or more listed chemicals for which the warning is being given. Thus, the

reference in Section 25601(b) would also be removed.

§ 25602. Consumer Product Exposure Warnings – Methods of

Transmission.

Subsection (a)

OEHHA is proposing a non-substantive amendment to subsection (a) by

replacing the existing reference to Section 25607.1 with a reference to Section

25607. This change is proposed to correct a typographical error in the existing

regulation.

OEHHA is additionally proposing substantive changes to subsection (a). The

word “product” would be added before the word “label” in subsections (a)(3) and

(a)(4), to clarify that use of this warning method is limited to the physical

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parameters of a consumer product label and therefore cannot be used in other

circumstances such as warnings for environmental exposures.

Amendments to Subsection (a)(4) specify the three conditions that would allow

for the use of a short-form warning on a consumer product. Namely, a short-form

warning may only be used if:

(A) the total surface area of the product available for labeling is 5 square

inches or less, and;

(B) the package shape or size cannot accommodate the full-length warning

content described in Section 25603(a), and

size used for other consumer information on the product, but in no case no

smaller than 6-point type.

Appendix B to this initial statement of reasons provides examples of the

proposed short-form warning content in 6, 8, and 10-point type sizes on an

approximately 5 square inch surface area.

In Subsection 25602(a)(4)(C), which sets forth the minimum 6-point type in a

short-form warning,

the words “must be” are deleted as no longer necessary

because of the proposed addition of the phrase “may only be used if” in

subsection (a)(4). The words “is printed” were added for consistency with the

requirement that the short-form warning be used only on product labels.

These proposed requirements would assure uniform prominence,

conspicuousness, and readability of the warning on small product packages

while eliminating the use of the short-form warning on labels for larger consumer

products that can easily accommodate the full warning message. The

amendments will ensure that a short-form warning option is still available for

consumer products sold in small packages.

Subsections (b) and (c)

Because there are generally fewer space limitations on a webpage or in a

catalog, use of a short-form warning is not appropriate in those contexts. The

amendments would delete the provisions stating, “If a warning is provided using

the short-form warning label…, the warning provided on the website may use the

same content” and “If a short-form warning is being provided on the label…the

warning provided in the catalog may use the same content” respectively. This

amendment is consistent with OEHHA’s determination that the short-form

warning should only be used for products with small packaging, and that there

The existing type size requirement of Section 25602, subsection (a)(4) is unchanged

by this rulemaking proposal.

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are no comparable space limitations on a webpage or product catalog. Because,

as discussed below, the short-form warning will include specific chemical-

exposure information, the additional information needed for a website or catalog

warning will be minimal. In addition, these amendments will help reduce

potentially unnecessary warnings for products sold online or via a catalog when

the business does not know there is an exposure to a listed chemical from that

consumer product. OEHHA believes these amendments will discourage

unnecessary prophylactic warnings which dilute the effectiveness of warnings for

actual exposures to listed chemicals.

Subsection (e)

New subsection (e) would provide a one-year delayed operative date after the

effective date of the amendments to allow businesses time to make the

necessary changes to their safe harbor warnings. During this one-year phase-in

period, businesses would have the option of using either the 2016 version of the

short-form regulations that became operative in 2018, or the amended

provisions. OEHHA is aware that modifying the short-form warning provisions

may require some retooling by businesses who chose to comply with these safe

harbor regulations. These effects should be short-term, however, and any

related costs can be spread over the one-year phase in period.

Proposed subsection (e) also includes a “sell-through” provision to facilitate

compliance with the amended regulations. During the 2016 rulemaking, some

manufacturers expressed concern over anticipated logistical and economic costs

associated with changing the warnings on products already produced and

distributed to the marketplace. This was of particular concern to businesses

dealing in durable goods produced with compliant warnings and a long shelf-life.

To alleviate similar concerns, OEHHA has included a “sell-through” provision for

products manufactured before the operative date of the amendments to the

short-form warning provisions.

In other words, short-form warnings on products manufactured prior to the

operative date of the amendments will continue to be considered compliant if

they comply with the earlier regulations. Although the proposed amendments are

narrowly focused and will impact only those businesses currently providing short-

form safe harbor warnings, OEHHA believes the sell-through period will help

mitigate or avoid potential logistical issues and will allow manufacturers and

retailers sufficient time to transition to the new content without the need to locate

and re-label products already in the chain of commerce. Similar sell-through

provisions would be added to the amended consumer product exposure

warnings content in Section 25603 and the food exposure warnings content in

Section 25607.2.

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§ 25603. Consumer Product Exposure Warnings – Content.

Subsection (a)

OEHHA is proposing a non-substantive amendment to subsection (a) by

replacing the existing reference to Section 25607.1 with a reference to Section

25607. This change is proposed to correct a typographical error in the existing

regulation.

Subsection (b)

The proposed amendments would revise subsections (b)(2)(A) – (b)(2)(C) and

add new subsection (b)(2)(D). The words “pursuant to Section 25602(a)(4)” are

proposed for addition to subsection (b) to make clear that short-form warnings

may only be used when the applicable requirements of Section 25602(a)(4)

concerning the available surface area on a product label and the ability to

accommodate a full-length warning, and the minimum type size requirements are

met. The amended regulation would change the safe harbor short-form warning

content to require that the name of one or more listed chemicals for which the

warning is being provided is stated in the warning. Subsection (b)(2)(D) would

be added to provide short-form warning content for an exposure to a chemical

that is listed as both a carcinogen and reproductive toxicant. This is consistent

with the full-length warning in Section 25603(a)(2)(D) which addresses the same

scenario.

The warning content has also been modified by adding the terms “risk” and

“exposure” to warn a consumer that there is a risk of cancer and/or reproductive

harm from exposure to a listed chemical from a consumer product. This warning

is more precise and informative than the current short-form warning that only

refers to the end point, i.e., “Cancer” and/or “Reproductive Harm”.

The term “risk”, added with reference to the applicable endpoint(s), will help

better convey the risk a consumer is facing from exposure to the listed chemical.

OEHHA has previously determined that informing people regarding exposures to

listed chemical chemicals is consistent with the right-to-know purpose of the Act.

As OEHHA noted in the 2015 ISOR for Article 6:

“Further, Proposition 65 is a right-to-know law. The purpose of the statute

is to provide people with notice concerning their exposures to listed

chemicals. The preamble to the law states in part that:

‘Section 1. The people of California find that hazardous chemicals pose a

serious threat to their health and well-being . . . . The people therefore

declare their rights: . . . . (b) To be informed about exposures to chemicals

that cause cancer, birth defects, or other reproductive harm . . . .’

(Emphasis added)

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Clearly, the citizens who voted for the law wanted to be informed about

actual exposures to carcinogens and reproductive toxicants. They did not

anticipate that they would receive vague warnings about the content of the

products they purchase and use without providing any context for that

information. Such general warnings generate confusion and encourage

businesses to provide a warning even when none is required, precisely

because they are so vague and meaningless. Requiring that the warnings

include more specific, relevant information will further the right-to-know

purposes of the law and reduce the likelihood that businesses will provide

unnecessary warnings for non-existent or insignificant exposures.”

OEHHA has determined that the concept of exposure is an important component

of the full-length Proposition 65 safe harbor warnings and should likewise be

incorporated in the short-form consumer product exposure warnings. As an

example, a short-form warning for a consumer product exposure to the

carcinogen Diisononyl Phthalate (DINP) would read thus:

WARNING: Cancer Risk From

Diisononyl Phthalate (DINP) Exposure –

www.P65Warnings.ca.gov.

The short form warning authorized in the proposed regulations thus would

provide businesses with the continued option to use truncated, short-form

warning content for consumer products that have little available surface space for

a warning. At the same time, the inclusion of the name of at least one listed

chemical (or two chemicals if the exposures are to a carcinogen and a

reproductive toxicant) would further consumers’ right-to-know about listed

chemicals they may be exposed to from a consumer product.

The proposed modifications would also help curb the current business practice of

providing unnecessary “prophylactic” warnings without knowledge of any

exposure to a listed chemical from the consumer product.

Subsections (c) and (d)

Subsection (c) would be deleted because the changes to subsections (b)(2)(A) –

(b)(2)(C) and new subsection (b)(2)(D) would require the name of one or more

listed chemicals in short-form consumer product exposure warnings. The

elimination of subsection (c) necessitates the renumbering of current subsection

(d) to (c).

New subsection (d) would be added to include the one-year delayed operative

Article 6 ISOR (2015), supra note 3.

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date discussed above for the amendments to Section 25603 to facilitate

transition to the amended safe harbor warnings. It would also provide a

sell-through provision, as described above in the discussion of Section 25602.

Additionally, the amended regulations would not become operative until one year

after their adoption. During this one-year period, businesses will have the option

of using either 2016 version of the short-form warning provisions that became

operative in 2018, or the modified short-form warning. The “sell-through”

provision in subsection (d) applies to products manufactured before the operative

date of the amendments to this section. Under this provision, compliance with

the 2016 version of the short-form warning regulation will be considered

compliant with the proposed regulation if the consumer product was

manufactured prior to the operative date of the proposed amended regulation.

§ 25607.2. Food Exposure Warnings – Content.

The proposed amendments would add new subsections (b)(1) – (b)(6) and (c) to

the tailored warning for food exposures. When OEHHA adopted the short-form

warning content for safe harbor consumer product exposure warnings in the

2016 Clear and Reasonable Warnings rulemaking, OEHHA did not anticipate

businesses using short-form warnings for food products. As businesses began

providing Proposition 65 warnings using the new safe harbor warning methods

and content, OEHHA received numerous inquiries from businesses seeking

clarification as to whether the short-form warning could be used as a safe harbor

warning for food products. This proposed rulemaking would clarify that

short-form warnings may be used to provide safe harbor warnings for food

products, with appropriate modifications to conform to the existing full-length

warning requirements for food exposure warnings (i.e., the warning symbol is not

required for foods, but the warning must be enclosed in a box).

Subsection (a)

Subsection (a) would be modified by replacing the words “is provided via” and

adding the words “complies with” to emphasize that compliance with the methods

in Section 25607.1 for food exposure warnings is required for safe harbor

protection. Existing Section 25607.1(a) requires that the safe harbor warning for

food exposures be provided using one or more of the methods required in

Section 25602 for consumer product exposures, in addition to the requirements

specific to food exposures described in Section 25607.1, subsections (b) and (c).

Subsection (b)

OEHHA has determined that certain elements of the existing tailored warning for

food exposure warnings should be retained in the short-form warning content.

New subsections (b)(1)-(6) would provide short-form warning content that is

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generally consistent with the other proposed amendments to the short-form

warning content for consumer product exposure warnings and would incorporate

existing elements of the full-length warning content for food exposures. Thus the

proposed short-form food exposure warning would be subject to the

requirements in Section 25602(a)(4) regarding available surface space on a

product label and the inability to accommodate a full-length warning, and the

minimum type-size requirements; would omit the warning symbol and would

require the warning to be enclosed in a box on food labels, consistent with the

current full-length warning for food exposures.

The warning message would

include the signal word “WARNING”, the endpoint (cancer and/or reproductive

toxicity), the name of one or more of the listed chemicals for which the warning is

being provided, and the food exposure warnings URL:

www.P65Warnings.ca.gov/food.

As an example, a short-form warning for a food product exposure to the

carcinogen and reproductive toxicant benzene would read thus:

As with other safe harbor warnings, including those on consumer products other

than food, where a chemical is both a carcinogen and reproductive toxicant the

level of exposure may require a warning for one endpoint but not the other. In

this scenario a warning should be given only for the endpoint requiring a warning.

For example, for the carcinogen and reproductive toxicant acrylamide, if the

exposure exceeds the No Significant Risk Level of 0.2 micrograms/day for

cancer but is below the Maximum Allowable Dose Level of 140 micrograms/day

for reproductive toxicity, a warning should be given only for the increased risk of

cancer:

Subsection (c)

Subsection (c) provides the same one-year delayed operative date for the

amendments and sell-through provision as described in the discussion of

Sections 25602 and 25603 above. The sell-through provision in subsection (c)

Section 25607.1(b).

WARNING: Risk of Cancer and

Reproductive Harm From Benzene

Exposure – www.P65Warnings.ca.gov/food.

WARNING: Cancer Risk From Acrylamide

Exposure – www.P65Warnings.ca.gov/food.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

INITIAL STATEMENT OF REASONS Page 15

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applies to warnings on food products manufactured or produced and labeled

before the operative date of the amendments to this section. As noted above,

the version of the short-form warning which became operative in 2018 will be

considered compliant with the proposed regulation if the food product was

manufactured or produced prior to the operative date of the amended regulation.

Necessity

The proposed regulation is necessary to stop businesses’ use of the short-form

warning described above on large packages, in catalogs and on-line to

discourage its use to warn prophylactically. Those uses of the short-form warning

are contrary to OEHHA’s intention when adopting the 2016 warning regulations

that businesses provide consumers with more meaningful and informative

warnings, avoid over-warning, and only use the short form warning where the

full-length warning will not fit on the label. The same is true for warnings provided

in catalogs and on-line as there are not the same space limitations in those

situations. In addition, the proposed regulation is necessary to ensure that, when

appropriately used on products with small packages, the short-form warning

names at least one chemical and clarifies that use of the product can cause a

chemical exposure. .

Benefits of the Proposed Regulation

The health and welfare of California residents will likely benefit because the

regulation will improve the quality of information provided in Proposition 65

consumer-product warnings by ensuring all safe-harbor warnings name at least

one listed chemical to which the user of the product can be exposed. The

regulation will also benefit Californians by discouraging and reducing

unnecessary prophylactic warnings that can mislead consumers into thinking a

product causes an exposure to a listed chemical when that is not the case.

Technical, Theoretical, and/or Empirical Study, Reports, or

Documents Relied Upon

OEHHA did not rely on any technical, theoretical, and/or empirical studies,

reports, or documents as part of this rulemaking.

Reasonable Alternatives to the Regulation and the Agency’s

Reasons for Rejecting Those Alternatives

OEHHA considered repealing the short-form warning provisions entirely.

OEHHA decided that in certain limited circumstances, namely when product

packaging size constraints cannot accommodate full-length warnings, provisions

for shortened yet informative warnings are necessary. Thus, OEHHA has

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

INITIAL STATEMENT OF REASONS Page 16

TITLE 27, CALIFORNIA CODE OF REGULATIONS

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determined there are no reasonable alternatives to the proposed regulatory

action that would carry out the purposes of the Act. The action provides

clarification and specificity to the existing regulations.

Reasonable Alternatives to the Proposed Regulatory Action that

Would Lessen Any Adverse Impact on Small Business and the

Agency’s Reasons for Rejecting Those Alternatives

OEHHA considered the alternative of repealing the short-form provisions in their

entirety but determined that the short-form warnings are necessary when the

surface area of a product label is very limited and the package shape or size

cannot accommodate a full-length warning, as was originally intended when

OEHHA adopted the short-form warning as a safe harbor warning method for

consumer product exposures. OEHHA has determined that no reasonable

alternative considered by OEHHA, or that has otherwise been identified and

brought to the attention of OEHHA, including alternatives that would lessen any

adverse impact on small business, would be as effective or less burdensome on

small business. In addition, OEHHA has determined that the proposed

regulatory action will not impose any mandatory requirements on small

businesses. Proposition 65 expressly exempts businesses with less than 10

employees

from the requirements of the Act.

Evidence Supporting Finding of No Significant Adverse

Economic Impact on Business

The proposed regulatory action will not have a significant adverse economic

impact directly affecting businesses, including the ability of California businesses

to compete with businesses in other states. The action does not impose any new

requirements upon private persons or businesses because the safe harbor

regulations are non-mandatory guidance.

Efforts to Avoid Unnecessary Duplication or Conflicts with

Federal Regulations Contained in the Code of Federal

Regulations Addressing the Same Issues

Proposition 65 is a California law that has no federal counterpart. OEHHA has

determined that the regulatory action does not duplicate and will not conflict with

federal regulations.

Health and Safety Code section 25249.11(b).

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

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Economic Impact Assessment Required by Gov. Code section

11346.3(b)

Creation or Elimination of Jobs within the State of California

The proposed regulatory action will not impact the creation or elimination of jobs

within California. The proposed amendments will ensure that that the safe

harbor short-form warnings are only used where, due to limited label space on a

consumer product, a full-length warning will not fit. The proposed warnings will

include the name of at least one listed chemical to which the person may be

exposed to provide consumers with sufficient information about the exposure.

The proposed action will also provide clarification and specificity regarding use of

short-form warnings for exposures to listed chemicals from food.

Creation of New Businesses or Elimination or Expansion of Existing

Businesses within the State of California

The proposed regulatory action will not impact the creation of new businesses or

the elimination or expansion of existing businesses within California. The

proposed amendments will ensure that that the safe harbor short-form warnings

are only used where, due to limited label space on a consumer product, a full-

length warning will not fit. The proposed warnings will include the name of at

least one listed chemical to which the person may be exposed to provide

consumers with sufficient information about the exposure. The proposed action

will also provide clarification and specificity regarding the use of short-form

warnings for exposures to listed chemicals from food.

Benefits of the Proposed Regulation to the Health and Welfare of California

Residents, Worker Safety, and the State’s Environment

The proposed regulatory action will benefit the health and welfare of California

residents by providing more meaningful information regarding their exposures to

listed chemicals and help eliminate over-warning for non-existent exposures to

listed chemicals. The action will also provide clarification and specificity regarding

the use of short-form warnings for exposures to listed chemicals from food. The

proposed action furthers the right-to-know purposes of the statute and therefore

promotes public and worker health and safety.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

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AMENDMENTS TO ARTICLE 6

Appendix A – Examples of Actual Short-Form Warnings

Residential Trash Bin Warning

Ceramic Tower Heater – On-Product Label

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

INITIAL STATEMENT OF REASONS Page 19

TITLE 27, CALIFORNIA CODE OF REGULATIONS

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Appendix A – Examples of Actual Short-Form Warnings, cont.

Electric Range – On-Product Label

Dishwasher - Website Warning

Top Freezer Refrigerator - Website Warning

Prop 65 CALIFORNIA RESIDENTS ONLY -

WARNING: Cancer and Reproductive Harm -

www.P65Warnings.ca.gov.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

INITIAL STATEMENT OF REASONS Page 20

TITLE 27, CALIFORNIA CODE OF REGULATIONS

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Appendix A – Examples of Actual Short-Form Warnings, cont.

Refrigerator - On-Product Label

Clothes Dryer - Website Warning

Guitar, Bass and Ukulele - Website Warning

Luggage – On-Product Label

Prop 65 CALIFORNIA RESIDENTS ONLY –

WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov.

WARNING: Cancer and Reproductive Harm - www.p65Warnings.ca.gov.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

INITIAL STATEMENT OF REASONS Page 21

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Appendix B - Examples of Short-form Warnings Compliant

with the Proposed Amended Regulations on 5 sq. in Product

Surface Area*

*all dimensions are approximate

Short-form warning on 5” x 1” product surface area

Reproductive Harm risk (8 pt.)

Cancer and Reproductive Harm risk from same chemical (8 pt.)

Cancer and Reproductive Harm risk from different chemicals (8 pt.)

WARNING: Risk of Reproductive Harm From Toluene Exposure – www.P65Warnings.ca.gov.

WARNING: Risk of Cancer and Reproductive Harm From Benzene Exposure –

www.P65Warnings.ca.gov.

WARNING: Risk of Cancer From Formaldehyde and Reproductive Harm From Toluene

Exposure – www.P65Warnings.ca.gov.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

INITIAL STATEMENT OF REASONS Page 22

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Examples of Short-form Warnings Compliant with the Proposed

Amended Regulations on 5 sq. in, cont.

Short-form warning on 3” x 1.75” Product Surface Area

Cancer risk (8 pt.)

Cancer and Reproductive Harm risk from same chemical (8 pt.)

Cancer and Reproductive Harm risk from different chemicals (8 pt.)

WARNING: Cancer Risk From Formaldehyde Exposure

- www.P65Warnings.ca.gov.

WARNING: Risk of Cancer and Reproductive

Harm From Benzene Exposure -

www.P65Warnings.ca.gov.

WARNING: Risk of Cancer From Formaldehyde and

Reproductive Harm From Toluene Exposure -

www.P65Warnings.ca.gov.

Examples of Short-form Warnings Compliant with the Proposed Amended

Regulations on 5 sq. in, cont.

Short-form warning on 2.5” x 2” Product Surface Area

Reproductive Harm risk (8 pt.)

Cancer and Reproductive Harm

risk from same chemical (8 pt.)

Cancer and Reproductive Harm risk

from different chemicals (8 pt.)

WARNING: Risk of Reproductive Harm

From Toluene Exposure -

www.P65Warnings.ca.gov.

WARNING: Risk of Cancer and

Reproductive Harm From Benzene Exposure -

www.P65Warnings.ca.gov.

WARNING: Risk of Cancer From

Formaldehyde and Reproductive Harm From

Toluene Exposure - www.P65Warnings.ca.gov.