Initial Statement of Reasons
Title 27, California Code of Regulations
Proposed Amendments to Article 6
Clear and Reasonable Warnings
New Sections 25607.48 and 25607.49
Warning s for  Exposures to Glyphosate from Consumer Products
July 23, 202 1
California Environmental Protection Agency
Office of Environmental Health Hazard Assessment
2Contents
Initial Statement of Reasons  ................................ ................................ ...........................  1
Title 27, Cal ifornia Code of Regulations  ................................ ................................ ..........  1
Proposed Amendments to Article 6  ................................ ................................ .................  1
Clear and Reasonable Warnings  ................................ ................................ ....................  1
New Sections 25607.48 and 25607.49 ................................ ................................ ............  1
Warnings for Exposures to Glyphosate from Consumer Products  ................................ .. 1
July 2 3, 2021  ................................ ................................ ................................ ...................  1
California Environmental Protection Agency  ................................ ................................ ... 1
Office of Environmental Health Hazard Assessment  ................................ .......................  1
Summary  ................................ ................................ ................................ .........................  4
Background and Problem to be Addressed by the Proposed Rulemaking  ......................  5
Basis for glyphosa te Proposition 65 listing  ................................ ................................ ...........................  5
Cancer conclusions about glyphosate by other entities  ................................ ................................ .......  5
Proposition 65 safe harbor warning for glyphosat e in consumer products  ................................ .........  6
Additional application of Proposition 65 consumer product warning  ................................ .................  7
Public health importance of clear and i nformative warning for glyphosate  ................................ ........  9
Proposed Amendments  ................................ ................................ ................................ . 12
Section 25607.48 Warnings for Exposures to Glyphosate from Consumer Produ cts– 
Methods of Transmission.  ................................ ................................ ................................ ..................  13
Section 25607.49 Warnings for Exposure to Glyphosate from Consumer Products – 
Content  ................................ ................................ ................................ ................................ ...............  13
Necessity  ................................ ................................ ................................ .......................  14
Economic Impact Assessment Required by Government Code Section 
11346.3(b)  ................................ ................................ ................................ .....................  15
Creation or elimination of jobs within the State of California  ................................ ............................  15
Creation of new businesses or elimination of existing businesses within the State of 
California  ................................ ................................ ................................ ................................ .............  15
Expansion of busine sses currently doing business within the State of California  ..............................  16
Benefits of the proposed regulation to the health and welfare of California residents, 
worker safety, and the state’s environment  ................................ ................................ ......................  163Technical, Theoretical, and/or Empirical Study, Reports, or Documents Relied 
Upon  ................................ ................................ ................................ ..............................  16
Benefits of the Proposed Regulation  ................................ ................................ .............  16
Reasonable Alternatives to the Regulation and the Agency’s Reasons for 
Rejecting Those Alternatives  ................................ ................................ .........................  16
Reasonable Alternatives to the Pro posed 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  ................................ ................................ ................................ ........................  17
Efforts to Avoid Unnecessary Duplication or Conflicts with Federal Regulations 
Contained in the Code of Federal Regulations Addressing the Same Issues  ...............  174Summary
The Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency 
that implements Proposition 651and has the authority to promulgate and amend 
regulations to implement and further the purposes of the Act. OE HHA is proposing to 
adopt a new non-mandatory, safe harbor warning regulation to address the content of 
warnings for exposure to glyphosate from consumer product s.
This proposed rulemaking would add Section s 25607. 48 and 25607.49 to the Title 27, 
Article 6  Clear and Reasonable Warning s regulations. The proposed regulation s would 
provide  safe harbor  guidance for businesses that cause consumer product exposures to 
glyphosate that require warning2. The new regulation s would further the “right -to-know” 
purposes  of the Act and provide warning language tailored  for these exposures. 
Businesses who choose to provide the safe harbor warning language for such 
exposures would comply  with the Act , because the content and methods provided in the 
regulation are deemed “cl ear and reasonable” by the lead agency for purposes of the 
Act. The warning is int ended to provide balanced and understandable information to 
individuals who may be exposed to glyphosate  at levels requiring warning .
The proposed  regulation allow s for the use of the signal words “Notice” or “Attention” on 
product labels to conform with existing safe harbor warning  content  for pesticides3, 
including glyphosate, regulated by US Environmental Protection Agency (US EPA) and 
the California Department of Pesticide  Regulation. This provision was adopted effective 
July 1, 2018,  to avoid any conflict with standard signal words used on product labels for 
chemicals regulated by these authorities.
                                           
1 The Safe Drinking Water and Toxics Enforcement Act of 198 6, codifi ed at Health and Safety Code 
Section 25249.5 et seq., commonly known as Proposition 65, herein referred to as the “Act” or 
Proposition 65.
2 For carcinogens, a warning  is not required when the person responsible can show the exposure poses 
no significant r isk assuming lifetime exposure at the level in question (Health and Safety Code Section 
25249.10). OEHHA adopted a No Significant Risk Level (NSRL) of 1100 micrograms per day in Title 27, 
Cal. Code of Regs., section 25705. Exposures below this safe harbor level do not require warning.
3 Subsection 25603 (d): “Notwithstanding subsection (a)(2) or (b)(2), where a warning for a consumer 
product exposure or occupational exposure from use of a pesticide is provided on a product label, and the 
pesticide label is r egulated by the United States Environmental Protection Agency under the Federal 
Insecticide, Fungicide, and Rodenticide Act,  Title 40 Code of Federal Regulations, Part 156; and by the 
California Department of Pesticide Regulation under Food and Agricultura l Code Section 14005, and Cal. 
Code of Regs., title 3, Section 6242; the word “ ATTENTION ” or “ NOTICE ” in capital letters and bold type 
may be substituted for the word “ WARNING ”.5Existing regulations4describe the safe harbor methods for providing consu mer product 
warnings  in cases where there are not tailored warnings . OEHHA is incorporating them 
by reference since no special methods are needed for these warnings. 
Background  and Problem to be Addressed by the Proposed Rulemaking
Basis for glyphosate Pr oposition 65 listing 
Glyphosate is a registered herbicide used extensively in consumer products.  It was 
listed in 2017 under Proposition 65 via the “Labor Code” listing mechanism5based on a 
finding by the W orld Health Organization’s  International Agency for Research on Cancer 
(IARC) that the chemical is “probably carcinogenic to humans”  (Group 2A) , and that 
there was  “sufficient evidence ” of carcinogenicity in experimental animals  67. In 
evaluating studies of cancer in humans, IARC concluded: “There is l imited evidence in 
humans for the carcinogenicity of glyphosate. A positive association has been observed 
for non -Hodgkin lymphoma.”  
Cancer conclusions about glyphosate by other entities
The European Chemicals Agency (ECHA)8in its 2016 evaluation essenti ally agreed 
with IARC’s conclusion regarding the human evidence:
“The DS [dossier submitter] concluded in accordance with IARC (2015 ) ‘There is 
limited evidence in humans for the carcinogenicity of glyphosate. ’ This is perhaps 
the best description of the a vailable data since the other IARC categories 
(“Evidence suggesting lack of carcinogenicity”; “Inadequate evidence of 
carcinogenicity”; “Sufficient evidence of carcinogenicity”) are even less suitable. ” 
Regarding the animal data ECHA found inconsistencies  within each of the three tumor 
types that had positive findings in multiple experiments in mice (malignant lymphoma, 
                                           
4 Title 27, Cal. Code of Regs., section 25602.
5 Title 27, Cal. Code of Regs.,  section 25904(b)(2).
6 The listing of glyphosate as a carcinogen was upheld on appeal  in Monsanto Co. v. Office of 
Environmental Health Hazard Assessment , 22 Cal. App. 5th 534 (Ct. App. 2018), review denied (Aug. 15, 
2018) .
7 International Agency for Rese arch on Cancer (IARC), Glyphosate Monograph  in: Some 
Organophosphate Insecticides  and Herbicides, IARC Monographs on the Evaluation of the Carcinogenic 
Risks to Humans, Volume 112 . World Health Organization, IARC, available at:  
https://publications.iarc.fr/549 . 
8 European Chemicals Agency (ECHA), CLH report. Proposal for Harmonised Classification and 
Labelling. Based on Regulation (EC) No  1272/2008 (CLP Regulation), Annex VI, Part 2. Substance 
name: N -(phos phonomethyl)glycine; Glyphosate (ISO) , May 2016 , Available at:  
https://echa.europa.eu/documents/10162/13626/clh_report_glyphosate_en.pdf . 6renal tumors, haemangiosarcoma) and overall found that the data were  insufficient to 
identify glyphosate  as a carcinogen.   
The French Age ncy for Food, Environmental and Occupational Health and Safety 
(ANSES) 9determined that the evidence was insufficient for finding glyphosate to be a 
presumed carcinogen but that the substance could possibly be classified in Category 2 
[suspected human car cinogen ] but could not reach a decision absent a detailed analysis 
of the data . ANSES called on the European Chemicals Agency (ECHA) to rapidly 
review glyphosate.
On the other hand, t he US Environmental Protection Agency (US EPA) has concluded 
that glyphos ate is “ Not likely to be carcinogenic to humans”10, and some other 
governmental agencies that regulate pesticides reached  similar conclusions.11
While the lack of consensus in scientific opinions is not unusual in risk evaluation of 
chemicals, this is an unu sual case because several  regulatory agencies did not 
reach a similar  conclusion as IARC. T he standard Proposition 65 safe harbor 
warning language – which includes the phrase “known to cause cancer”  – is not the 
best fit in this situation . Therefore, OEHHA  is proposing tailored language for 
warnings for glyphosate that presents a balanced description of  the likelihood that 
glyphosate can cause human cancer. 
Proposition 65 safe harbor w arning for glyphosate in consumer products
Proposition 65 require s a war ning f or significant exposures to listed carcinogens .  A 
warning is  not required  when the person responsible for the exposure can show th at it
                                           
9 ANSES (2016). Opinion of  the French Agency for Food, Environmental and Occupational Health and 
Safety on the glyphosate request No 2015 -SA-0093. Available at: 
https://www.anses.fr/en/system/files/SUBCHIM2 015sa0093EN.pdf . 
10 US Environmental Protection Agency (US EPA 2020). Interim Registration Review Decision. Case 
Number 0178. January 22, 2020. U.S. Environmental Protection Agency, Office of Pesticide Programs, 
available at: https://www.epa.gov/sites/production/files/2020 -01/documents/glyphosate -interim -reg-
review -decision -case -num-0178.pdf .
11 Canada: “glyphosate is unlikel y to pose a human cancer risk ”. Government of Canada, Pesticide 
Management Regulatory Agency, Summary, Re -evaluation Decision RVD 2017 -01, Glyphosate, April 
2017. Available at: https://www.canada.ca/en/health -canada/services/consumer -product -safety/reports -
publications/pesticides -pest-management/decisio ns-updates/registration -decision/2017/glyphosate -rvd-
2017 -01.html ; New Zealand: glyphosate is “unlikely to be genotoxic or carcinogenic to humans.” NZ 
Environmental Protection Authority, Review of the Evidence Relating to Glyphosate and Carcinogenicity. 
Prepared by W Temple, August 2016. See also Douwes et al. Carcinogenicity of glyphosate: why is New 
Zealand’s EPA lost in the weeds? NZ Med Assoc, 131 (1472): 82 -89, 2018. Available at: https://assets -
global.website -
files.com/5e332a62c703f653182faf47/5e332a62c703f6a2202fcb30_Douwes%20FINALpdf . 7poses no significant risk assuming lifetime exposure at the level in question12. Effective 
July 1, 2018, OEHHA ado pted a No Significant Risk Level  (NSRL)13for glyphosate of 
1100 micrograms per day . Exposures below  the safe harbor NSRL do not require a 
Proposition 65 warning. Current ly available information indicates that exposures to 
glyphosate from the use of many consumer products are likely  to be  lower than the 
NSRL and therefore will not require a warning. For example,  lifetime exposure 
estimates for a typical home user  of dilute , ready -to-use glyphosate -containing weed 
killer product can be estimated to be less th an the NSRL of 1100 micrograms per day14.  
Where  products result in exposures to consumers above the NSRL , a safe harbor 
warning can be used15. Occupational use rs of some glyph osate -containing consumer 
products may have  significant exposures because these pr oducts may be used 
frequently throughout the day  and year and in greater quantity , for example  by 
independent landscap ers.16
Additional application of Proposition 65 consumer product warning 
Proposition 65 applies to businesses with ten or more employees . For these businesses 
existing Proposition 65 safe harbor regulations provide guidanc e for providing warning 
to consumers and workers for exposures above a level posing no significant risk17. The 
business does not need to provide an additional warning wher e the  warning  being given 
for the chemical and endpoint fully complies with  the: Federal Hazard Communications 
Standard, or for pesticides , the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA ). 
In this case, US EPA,  which implements FIFRA , has d etermined no cancer warning is 
required for glyphosate on the product label.  Since occupational exposures  can occur 
through use of consumer products and  labeling  under FIFRA does not include a cancer 
warning , a business subject to Proposition 65 may choose  to provide a Proposition 65 
                                           
12 Health and Safety Code section 25249.10.  
13 No Significant Risk Levels are adopted by OEHH A as guidance for businesses and enforcers 
concerning when a warning is required for a given exposure (Title 27, Cal. Code of Regs., section 25701 
et seq.).
14 For example, exposure to a user that spills the product on the palmer surface of one hand  could b e 
estimated to be  approximately 110 µg glyphosate  via the dermal route , every time the product is used , 
and the product is not used every day  by a typical home user .
15 Title 27 Cal. Code of Regs., section 25601 et seq .
16 For example, a Safety Data Sheet  for one product implicitly notes the possibility of high exposure . 
“Handling: Avoid contact with eyes, skin or clothing. Avoid breathing spray mist. Users should wash 
hands before eating, drinking, chewing gum, using tobacco or using the toilet. Remove cloth ing 
immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. ” 
https://alligare.com/wp -content/uploads/2019/06/glyphosate -5.4-sds-v3.1.pd f.
17 Title 27, Cal. Code of Regs., section 25606 .8warning using the consumer product warning provisions of the safe harbor regulations .18  
Adopting a  tailored warning for glyphosate would facilitate occupational warnings for 
exposures that occur through use of consumer products  that contain glyphosate .
The US Occupational Safety and Health Administration  oversees  the federal Hazard 
Communication Standard  noted above , which  requires covered manufacturers, 
distributors , or importers to  provide a Safety Data Sheet  (SDS) , and among other 
things , such as training to employees  who can be exposed to hazardous chemicals .  
Employers must make the SDS available for review by their employees . The SDS is 
thus used “to communicate information to employees on hazardous chemical 
products.”19OEH HA has found SDS’s  for some glyphosate products  that state  the IARC 
finding along with findings by other agencies , including the US  EPA, but some do not  20. 
Below is an example of the type of information that may be  included in one SDS:
“Carcinogenicity / C hronic Health Effects: Prolonged overexposure to glyphosate 
may cause effects to the liver.  EPA has given glyphosate a Group E 
classification (evidence of non -carcinogenicity in humans). Canada PMRA has 
classified glyphosate as non -carcinogenic.  In 2015 IARC classified glyphosate 
as a probable human carcinogen Group 2A based on limited human evidence 
and some evidence in animals.”  21
As noted, w here no warning is being given for an exposure to a chemical  listed under 
Proposition 65  that is covered by the  provisions of Section 25606(a) , a business may 
use the consumer product , environmental or other tailored exposure warning  method s 
                                           
18 Title 27, Cal. Code of Regs.,  section 25606 (b): “For occupational exposures to chemicals not covered 
by subsection (a), warnings may be provided consistent with Sections 25601, 25602, 25603, 25604, 
25605  and 25607 et seq. of this Subarticle. ”
19 Occupational Safety and Health Administration (OSHA) Hazard Communication Safety Data Sheets. 
Available at: 
https://www.osha.gov/sites/default/files/publications/OSHA3493QuickCardSafetyDataSheet.pdf .
20 For example, the Bayer SDS for Roundup Promax ® Herbicide SDS dated 9/24/2020 states under the 
header “Assessment carcinogenicity”, “Potassium salt of glyphosate:  Based on available data, the 
classification criteria are not met. Important comment to IARC Listing:  Our expert opinion is that 
classification as a carcinogen is not warranted.”  
21 Safety Data Sheet for “Buccaneer 5 Herbicide” available online at: 
http://www.cdms.net/LDat/mp83M009.pdf . Note that IARC found “sufficient evidence ” of carcinogenicity  in 
experimental animals, not “some evidence. ”9and content  provided in the safe harbor regulations , as appropriate.  (Section 
25606(a)) .22232425
Public health importance of cle ar and informative warning for glyphosate
Avoiding  significant exposures to glyphosate is important from a public health 
perspective . IARC  concluded that “data from all studies combined show a statistically 
significant association between non -Hodgkin lymph oma and exposure to glyphosate.”26
While US EPA ultimately reached a different conclusion , many experts on the US EPA’s 
FIFRA27Scientific Advisory  Panel (FIFRA SAP)  found the Agency did not follow its own 
                                           
22 Section 25606 (b): For occupational exposures to chemicals no t covered by subsection (a), warnings 
may be provided consistent with Sections 25601, 25602, 25603, 25604, 25605 and 25607 et seq. of this 
subarticle .
23 California Labor Federation v. California Occupational Safety and Health Standards Board, 221 
Cal.App.3 d 1547, (Ct. App. 1990) “Nevertheless, it is undisputed that several million California workers 
are entitled to Proposition 65 warnings in the workplace if the proposition is not preempted by Fed/OSHA. 
Under these circumstances, we cannot accept the premis e that Proposition 65 is not a state law 
governing occupational safety and health within the meaning of Proposition 97 simply because it also 
applies outside the workplace and exempts certain employers from its requirements .” (at page 1557)
“… at oral argu ment counsel for the Board conceded that there are situations in which Proposition 65 
applies but the HCS does not, either in terms of chemicals covered or levels of exposure triggering 
warning requirements. For example, petitioners have alleged in the pet ition, and the Board has admitted, 
the highly relevant fact that incorporation of Proposition 65 in the present state plan will result in 
regulation of an additional 66 carcinogens and 18 reproductive toxins not currently so regulated. In our 
view, the sta te plan is not consistent with Proposition 65 unless it includes all of the protections afforded 
by the proposition. That Proposition 65 and the HCS both generally relate to the provision of warnings to 
employees regarding hazardous substances is simply no t sufficient to render the state plan consistent 
with the proposition. ” (Page 1558)
24 See Chemical Specialties Manufacturers Association v. Allenby, 958 F.2d 941 (9th Cir. 1992) 
“Manufacturers only become liable for misbranding when their labels are insuff icient, not for posting 
additional warning signs as dictated by state law. If manufacturer awareness of new product risks is 
triggered by the State of California's list of chemicals known to cause cancer or reproductive toxicity, then 
the list of chemicals  merely uncovers hazards that should have been uncovered by the manufacturers. 
The more likely scenario is that the hazards of a chemical are already known to both the manufacturer 
and the EPA, but that neither believes that cancer or reproductive toxicity  is a likely danger. In this 
scenario, it seems contradictory to assert that the EPA will prosecute a company for satisfying the 
standards developed by the EPA but deemed insufficient by the State of California.” ( Page  947)
25 See also, Title 8, Cal. Code o f Regs., section 5194 (b)(6) which incorporates Proposition 65 into the 
California Hazard Communication Standards.
26 IARC, March 1, 2016. Q&A on Glyphosate , available at: https://www.iarc.who.int/wp -
content/uploads/2018/11/QA_Glyphosate.pdf .
27 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA ), 7 U.S.C. §136 et seq .10Guidelines for Carcinogen Risk Assessment  in reachi ng this conclusion and  found the 
evidence of carcinogenicity suggestive28. 
“Many Panel members believe that the EPA did not provide convincing evidence 
of a lack of carcinogenic effects. These Panelists agreed that the four findings 
listed above are adequa te to reject the Issue Paper’s conclusion of “not likely to 
be carcinogenic to humans” and support a conclusion of “suggestive evidence of 
carcinogenic potential” under these Guidelines.”  29
Furthermore, the FIFRA SAP30as a whole  pointed out that the availa ble epidemiology 
studies evaluated by the US EPA did not include studies of “potentially more highly 
exposed workers, such as those who manufacture, formulate, or are involved in the 
wholesale handling or selling of glyphosate” , and characterized that abse nce as  
resulting in a “critical data -gap.”   
Since the IARC and US EPA evaluations , several researchers have published additional 
scientific evidence in the peer -reviewed literature that supports the concern  that high 
occupational exposure to glyphosate can lead to  non-Hodgkin lymphoma including 
epidemiologic findings in highly exposed individuals31,32, findings of non -Hodgkin 
                                           
28 FIFRA Scientific Advisory Panel  (FIFRA SAP) , SAP Minutes and Final Report No. 2017 -01. A Set of 
Scientific Issues Being Considered by the Environmental Protection Agency Regarding: EPA’s Evaluation 
of the Carcinogenic Potential of Glyphosate. December 13 -16, 2016. FIFRA Scientific Advisory Panel 
Meeting.  And March 16 , 2017,  Transmittal Memorandum. Fr om Steven Knott, Acting Executive Secretary 
FIFRA SAP Staff, to Rick Keigwin Acting Director, US EPA Office of Pesticide Programs.  Available at: 
https://www.epa.gov/sites/production/files/2017 -03/documents/december_13 -
16_2016_final_report_03162017.pdf .
29 Ibid, see pages 88 -89.
30 Ibid, see pages 15, 20, and 21.
31 Weisenburger DD, A Review and Update with Perspective of Evidence that the Herbicide Glyphosate 
(Roundup) is a Cause of Non -Hodgkin Lymphoma , Clinical Lymphoma, Myeloma and Leukemia, 2021 
online: https://www.sciencedirect.com/science/article/pii/S2 152265021001518 . Epidemiologic evidence 
reviewed in t his paper included  three meta -analyses  of epidemiology studies , two pooled analyses  of 
epidemiologic data , and one update of a large prospective cohort study . Each of these studies were 
published in the  peer-reviewed literature since the IARC review.
32 Meloni F, Satta G, Padoan M et al. Occupational exposure to glyphosate and risk of lymphoma:  results 
of an Italian multicenter case -control study. Environ Health. 2021 Apr 28;20(1):49.11lymphoma in multiple studies in mice exposed to glyphosate33,34, and emerging 
evidence on mechanisms of glyphosate induction of non -Hodg kin lymphoma .35
Proposition 65 was enacted to fill gaps36between various regulators where chemical 
hazard information is not being provided . It is important for individuals who are exposed 
to Proposition 65 listed chemicals to be given hazard information so they can make their 
own decisions about  exposures to these  chemicals. This issue has been discussed in 
tort cases brought by the plaintiffs’ bar37that are based on the allegation that exposures 
to glyphosate caused individuals ’ non-Hodgkin lymphoma . Some  of these cases have 
yielded multi -million -dollar verdicts that have survived appellate review, though some 
have had the jury -awarded damages reduced. 38In these cases , juries and courts have 
found warning to be an important  safeguard that was missing in these  situations . The 
safe harbor Proposition 65 warning can thus provide  information to people  to allow them 
to make informed decisions prior to exposure to Proposition  65 listed  chemicals. 
                                           
33 Weisenburger (2021 ), Ibid .
34 Portier CJ, A comprehensive analysis of the animal  carcinogenicity data for glyphosate from  chronic 
exposure rodent carcinogenicity  studies , Environmental Health, 19:18, 2020 , including supplementary 
information provided on the journal site.  Av ailable at: 
https://ehjournal.biomedcentral.com/articles/10.1186/s12940 -020-00574 -1.
35 Weisenburger (2021), Ibid.  Mechanistic evidence reviewed in this paper included two genotoxicity 
studies in human lymphocytes, three  genotoxicity and /or epigenetic studies in human peripheral blood 
mononuclear cells, and one study showing development of plasma cell neoplasms  in mice which 
resembled  a subtype of human  non-Hodgkin lymph oma. Each of these studies were  published in the 
peer-reviewed literature since the IARC review . 
36 “The people of California find that hazardous chemicals pose a serious potential threat to their health 
and well -being, that state government agencies have failed to provide them with adequate protection, and 
that these failures have been serious enough to lead to investigations by federal agencies of the 
administration of California's toxic protection programs.  The people therefore declare their rights: …(b)  To 
be informed about exposures to chemicals that cause cancer, birth defects, or other reproductive harm ...” 
(Preamble to Proposition 65 , the Safe Drinking Water and Toxic Enforcement Act, Available at: 
https://oehha.ca.gov/media/downloads/proposition -65/general -info/prop65ballot1986.pdf ).
37 E.g., Sara Randazzo and Jacob Bunge, Inside the Mass -Tort Machine That Powers Thousands of 
Roundup Lawsuits, W.S.J.,  November 25, 2019 (noting that more than 42,700 farmers, landscapers and 
home gardeners had sued Bayer AG for failing to warn of Roundup’s cancer risks), 
https://www.wsj.com/articles/inside -the-mass -tort-machine -that-powers -thousands -of-roundup -lawsuits -
11574700480 .
38 See for example,  In re Roundup Prod. Liab. Litgation, No. 16 -CV-0525 -VC, 2019 WL 3219360, (N.D. 
Cal., July 12, 201 9); In re Roundup Products Liability Litigation, MDL No. 2741, No. 3:19 -cv-02224 (N.D. 
Cal., Feb. 3, 2021; Johnson v. Monsanto Co.,52 Cal. App. 5th 434 (2020) .12OEHHA is aware of the District Court decision in the National Ass ociation of Wheat 
Growers39case in which the Plaintiffs challenged  a potential Proposition 65 warning for 
glyphosate. That  court found that , as applied to glyphosate,  the standard safe harbor 
warning was false and misleading under standard First Amendment analysis because it 
failed to address the situation presented in the case  where one respected authoritative 
body comes to conclusions with which other authorities disagree, including the US EPA. 
It similarly found that alternative warnings offered by the A ttorney General also would 
violate the First Amendment rights of the plaintiff businesses not to be compelled to 
provide information about their products that they believed was false and misleading. 
The District Court enjoined enforcement of the warning re quirement, but businesses 
were not enjoined from providing a warning if they choose to do so. Thus, OEHHA has 
developed the proposed regulation taking into account the concerns expressed in the 
District Court decision in that case. OEHHA’s  safe harbor regu lations are non -
mandatory guidance. OEHHA  does not have enforcement authority under Proposition 
65 and thus cannot require warnings to be given for an exposure to any listed chemical, 
including glyphosate.  The injunction in the National Wheat Growers case is still in effect .  
Therefore , no enforcement actions can be taken against businesses who do not provide 
warnings for significant exposures to this chemical . OEHHA does not intend to suggest 
otherwise by proposing this regulatory action.
The proposed warn ing would be adopted into the safe harbor regulations which identify 
warnings specifically determined to be “clear and reasonable” for purposes of 
Proposition 65 . It presents a balanced description of the conflict between IARC ’s 
conclusion and those of other regulatory agencies , including US EPA.  It also provides  
the clear message that  an individual’s  personal risk of cancer from use of these 
products  is a function of level and duration of exposure  to the chemical . In other words, 
not everyone who uses the product is in danger of contracting cancer.40Each of the 
statements in the proposed warning is factual.
Proposed Amendments 
Where use of a product is anticipated to result in exposures that exceed the NSRL, 
OEHHA is proposing that business es can provide a tailored  safe harbor Proposition 65 
warning that includes information  allowing the consumer to make an informed choice 
                                           
39 National Association of Wheat Growers et al. v. Becerra et al., United States District Court, Eastern 
District, Judge William B. Shubb.  Currently on appeal to the 9th Circuit Court of Appeals (case # 20 -
16758).  
40 Historically the pesticide label has not given much direction to users , and it did not tell use rs to take any 
specific precautions. A newer label (2015) for Roundup Ready can be found at 
https://images.thdstatic.com/catalog/pdfImages/be/be69d124 -d76e -481a -83dc -5775e25c0468.pdf . This  
label includes the following precautions:  
“7.1. Precautions for safe handling: Avoid contact with eyes. Avoid breathing vapour or mist. 
When using do not eat, drink or smoke. Wash hands thoroughly after handling or contact. Wash 
contaminated clothing bef ore re -use. Thoroughly clean equipment after use. Do not contaminate 
drains, sewers and water ways when disposing of equipment rinse water. ”13concerning their use of the product. The warning may also encourage consumers to 
follow label directions more carefully , thus reducing e xposures. The specific language 
for the proposed regulation is discussed below .
Section 25607.4 8 Warning s for Exposure s to Glyphosate from  Consumer Products – 
Methods of Transmissi on.
Proposed new Section 25607.48 would establish safe harbor warning methods  for 
exposures to glyphosate. The warning methods in this Section would allow a business 
to provide a safe harbor warning using the existing methods for consumer product 
warnings described in Section 25602.
Section 25607.49 Warning s for Exposure to Glyphos ate from Consumer Products  – 
Content
Proposed new Section 25607.49 would establish safe harbor warning content  for 
exposures to glyphosate.  The warning language for exposures to glyphosate being 
proposed in subsection (a) is as follows:
CALIFORNIA  PROPOS ITION 65 WARNING:  Using this product can expose 
you to glyphosate. The International Agency for Research on Cancer classified 
glyphosate as probably carcinogenic to humans. Other authorities, including US  
EPA, have determined that glyphosate is unlikely to  cause cancer, or that the 
evidence is inconclusive. A wide variety of factors affect your personal cancer 
risk, including the level and duration of exposure to the chemical. For more 
information, including ways to reduce your exposure, go to 
www.P65Warnings.ca.gov/glyphosate .
The proposed warning includes several elements of existing  safe harbor warnings 
adopted by OEHHA, including the warning symbol, signal word, the name of the 
chemical  and the URL where users can  access more information about the chemical , 
including ways to reduce exposure41.
This warning includes information on why the chemical is considered a carcinogen  (in 
part because it is classified as “probabl y carcinogen ic to humans”  by IARC ), and a 
statement that  the level and duration  of exposures affect  a person’s  cancer risk.  
                                           
41 See, Section 25602 , supra  note 5.
14Each of these statements is based on purely factual information contained in the listing 
record for glyphosate42or the supporting scientific inf ormation for the NSRL43.The 
statements regarding carcinogenicity also reflect the range of opinion, described 
above .44US EPA and some governmental bodies f ound  glyphosate  is unlikely to be a 
human carcinogen, while other bodies noted the evidence of effect s in epidemiology 
studies  and certain findings from animal  studies , but conclude d this evidence is   
insufficient for assigning a cancer category.
Consistent with safe harbor warning content for other pesticides given in subsection 
25603(d), subsection (b) p rovides that the signal words “ ATTENTION ” or “ NOTICE ” in 
capital letters and in bold may be substituted for the words “ CALIFORNIA  
PROPOSITION 65 WARNING”.  This provision was adopted to avoid any conflict with 
standard signal words used on product labels fo r chemicals regulated by the  US EPA or 
California  authorities. As stated in the ISOR for that rulemaking:
“In proposing this regulatory action, OEHHA intends to provide a narrow 
exception to the safe harbor provisions as they relate to the content of pesti cide 
exposure warnings on product labels. OEHHA is only allowing use of an alternate 
signal word in the narrow circumstance where the US EPA and DPR signal word 
and the Proposition 65 signal word conflict. This regulatory amendment will help 
businesses pro vide information that is useful to Californians about their potential 
exposures to listed pesticides and provide more guidance to affected businesses, 
thereby furthering the purposes of the Act.”45
Necessity 
Under the Act,  unless covered  by one of the exce ptions specified by the Proposition 65, 
if a business causes a significant exposure to a  chemical listed as a carcinogen it must  
provide a warning.  Glyphosate is listed as a carcinogen based on IARC’s conclusions . 
As discussed above, however, other bodies have reached different  conclusions . 
Industry groups have argued in litigation against the Attorney General that, because the  
IARC findings diverge  from those of regulatory bodies , the warning requirement as 
                                           
42 https://oehha.ca.gov/proposition -65/crnr/glyphosate -be-listed -under -proposition -65-known -state -cause -
cancer ; https://oehha.ca.gov/proposition -65/crnr/glyphosate -listed -effective -july-7-2017 -known -state -
california -cause -cancer .
43 OEHHA (2017) Initial Statement of Reasons, Proposed Amendment to Section 25705(b) Specific 
Regulatory Levels Posing No Significant Risk, https://oehha.ca.gov/media/glyphosate032917isor.pdf  ; 
OEHHA (2018) Final Statement of Reasons, Section 25705(b) Specific Regulatory Levels Posing No 
Significant Risk, No Significant Risk Level: Glyphosate, available at: 
https://oehha.ca.gov/media/downloads/crnr/glyphosatensrlfsor041018.pdf .
44 See section  above : “Cancer conclusions  about glyphosate by other  entities .”
45 Initial Statement of Reasons, Title 27, California Code of Regulations, Proposed Amendments to Article 
6 Clear and Reasonable Warnings Amendment to Section 25603 Consumer Product Exposure Warnings 
- Content : Signal Words for FIFRA -Regulated Pesticide Exposure Warning Labels, at 5 (2018).15applied to glyphosate would not comply with First  Amendment protections  for 
commercial speech .  
OEHHA has determined that a tailored safe harbor warning for significant glyphosate 
exposures from consumer products can provide clear and factual and information for 
the benefit o f those who could be exposed . As discussed above, where no consumer 
product warning is being given under FIFRA for significant exposures to glyphosate , the 
safe harbor language provides content and methods that businesses can use to provide 
a warning  if they choose to do so . Also, under OEHHA’s implementing regulations , a 
business that determines it must provide a warning for a worker exposure that is not 
required under FIFRA may use the proposed consumer product  safe harbor content  and 
methods to provide the warning , if appropriate. (Section 25606(a)).       
Avoiding significant exposures to carcinogens is very important from a public health 
perspective  and is precisely the reason Proposition 65 requires warnings about them . 
Since such warnings may not be required under Occupational  Safety and Health 
Administration ( OSHA ), California OSHA (Cal /OSHA ), or US  EPA requirements , it is 
even more  important that warning  language and methods be provided for significant 
exposures to listed  chemical s. This will facilitate the provision of warnin g to individuals  
who have a right to receive information that can help them make informed decisions 
about their exposures to listed chemicals . To facilitate glyphosate warnings in a manner 
that avoids the First Amendment concerns that have been raised abou t the standard 
consumer product warnings  when used in the context of glyphosate , OEHHA proposes 
to adopt a tailored warning. 
Economic Impact Assessment Required by Government Code Section 11346.3( b) 
In compliance with Government Code Section 11346.3, OEH HA has assessed all the 
elements pursuant to Sections 11346.3(b)(1)(A) through (D).
Creation or elimination of jobs within the State of California
This regulatory action will not impact the creation or elimination of jobs within the State 
of California. Th e proposed regulation will help businesses comply with the warning 
requirements of Proposition 65 by providing specific  safe harbor content for warnings for 
exposures to glyphosate . 
Creation of new businesses or elimination of existing businesses within t he State of 
California
This regulatory action will not impact the creation of new businesses or the elimination 
of existing businesses within the State of California. The proposed regulation will help 
businesses comply with the requirements of Proposition 65 by providing specific  safe 
harbor methods and  content for consumer product warnings for exposure  to glyphosate .   16Expansion of businesses currently doing business within the State of California
This regulatory action will not impact the expansion of bu sinesses within the State of 
California. The proposed regulation will provid e specific safe harbor methods and  
content for consumer product warnings for exposure  to glyphosate.    
Benefits of the proposed regulation to the health and welfare of California residents, 
worker safety, and the state’s environment
OEHHA has concluded that the public would benefit from the proposed amendments 
because  businesses will understand how to comply with the warning requirements such 
that warnings considered to be clear an d reasonable are provided to Californians using 
consistent and uniform content and methods. The action furthers the right -to-know 
purposes of the statute and therefore promotes public and worker health and safety.
Technical, Theoretical, and/or Empirical S tudy, Reports, or Documents Relied 
Upon 
Citations to documents relied on for this proposal are cited  in this document. Copies of 
these documents will be included in the regulatory file for this action and are available 
from OEHHA upon request .
No other te chnical, theoretical, or empirical material was relied upon by OEHHA in 
proposing the adoption of this regulation .
Benefits of the Proposed Regulation 
Regulated businesses that choose to follow the safe harbor provisions of the clear and 
reasonable warnin g regulations when providing warnings for exposures to glyphosate 
will likely benefit from the proposed amendments because the amendments provide 
guidance  and safe harbor protection for businesses causing exposures to glyphosate  
from consumer  products .
Reasonable Alternatives to the Regulation and the Agency’s Reasons for 
Rejecting Those Alternatives
OEHHA has determined there are no reasonable alternatives to the proposed regulatory 
action that would carry out the purposes of the Act. The proposed action p rovides 
specificity to the regulations concerning how safe harbor warnings can be provided and 
what the warning message should include  for exposures to glyphosate .   
Reasonable Alternatives to the Proposed Regulatory Action that Would Lessen 
Any Adverse I mpact on Small Business and the Agency’s Reasons for Rejecting 
Those Alternatives17OEHHA has initially determined that no reasonable alternative considered by OEHHA, 
or that has otherwise been identified and brought to its attention, would be more 
effective  in carrying out the proposed action, or would be as effective and less 
burdensome to small business, or would be more cost -effective and equally effective in 
implementing the statutory policy or other provision of law to small business.  The 
current propos al furthers the purposes of Proposition 65 by  providing specific  safe 
harbor methods and  content for consumer product warnings for exposure  to glyphosate .   
Evidence Supporting Finding of No Significant Adverse Economic Impact on 
Business 
OEHHA does not anticipate that the regulation will have a significant statewide adverse 
economic impact directly affecting businesses, including the ability of California 
businesses to compete with businesses in other states. The proposed action  will 
provide  specific  safe harbor methods and  content  for consumer product warnings for 
exposure  to glyphosate.    
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 regulation do es not duplicate and will not conflict with federal law or 
regulations , including FIFRA .46
                                           
46 As noted previously , existing regulations concerning the use of alternative signal words for pesticide 
warnings are designed to avoid any conflict with standard signal wor ds under FIFRA  and the warning 
need not be provided on the product label .