Document ID: EPA-HQ-OPP-2011-0014-0001
Agency: epa
Document Type: Proposed Rule
Title: Labeling Requirements for Pesticides and Devices: Request to Require Labeling of Pesticides in Spanish and English
Posted Date: 2011-03-30T04:00Z

[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Proposed Rules]
[Pages 17607-17610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6884]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0014; FRL-8867-2]

40 CFR Parts 156 and 170

Receipt of Request To Require Pesticide Products To Be Labeled in 
English and Spanish

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of receipt of petition and request for comment.

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SUMMARY: This notice is to advise the public that the Migrant 
Clinicians Network and other farm worker interest groups have 
petitioned EPA to require all pesticide labels be available in both 
English and Spanish. The Agency is taking public comment on the request 
before responding to the petitioners.

DATES: Comments must be received on or before June 28, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0014, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0014. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Katie Weyrauch, Pesticide Re-
evaluation Division, Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703-308-0166; e-mail address: weyrauch.katie@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of 
interest to a wide range of stakeholders including human health, farm 
worker, agricultural and environmental advocacy groups; the chemical 
industry; pesticide users; and members of the public interested in the 
sale, distribution, or use of pesticides. Since others also may be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain fully why you agree or disagree; suggest alternatives 
and

[[Page 17608]]

substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used, as well as the sources of those data.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. Summary of Petition

    In December 2009, the Agency received a letter from the Migrant 
Clinicians Network (MCN), Farmworker Justice, and other farm worker 
advocacy organizations requesting that EPA require labeling in Spanish, 
in addition to the current requirement for English, on pesticide 
products. While this letter focused on farm workers, people in several 
other types of occupations apply pesticides or are exposed to 
pesticides routinely, such as lawn and landscape maintenance workers, 
structural pest control technicians, and commercial and residential 
cleaning staff. People in these occupations and Spanish-speaking 
consumers who use pesticide products at home may also be affected by 
the availability of pesticide labels in Spanish. The Agency is 
therefore seeking comment on this request as it applies to all of these 
stakeholders.
    Executive Order (EO) 13166 of August 11, 2000, orders federal 
agencies to improve access to federally conducted and federally 
assisted programs and activities for persons who, as a result of 
national origin, are limited in their English proficiency (LEP). The EO 
further states that, ``(in) carrying out this order, agencies shall 
ensure that stakeholders such as LEP persons and their representative 
organizations, recipients, and other appropriate individuals or 
entities, have an adequate opportunity to provide input. This input 
from stakeholders will assist the agencies in developing an approach to 
ensuring meaningful access by LEP persons that is practical and 
effective, fiscally responsible, responsible to the particular 
circumstances of each agency, and can be readily implemented.'' EPA's 
goals for this Federal Register notice are consistent with EO 13166 in 
that EPA is seeking public comment on the request for EPA to require 
that pesticide labels be available in English and Spanish. Input from 
the public will inform EPA's decision whether a requirement for English 
and Spanish on pesticide products ensures meaningful access by LEP 
persons that meets the objectives of this EO.
    EPA is treating this letter as a petition and is taking public 
comment on this request. The letter from the petitioners and EPA's 
response letter are located in docket EPA-HQ-OPP-2011-0014 associated 
with this Federal Register notice located at http://www.regulations.gov. The Agency would like the public to comment on the 
request for requiring labeling in Spanish, including information such 
as potential benefits, possible disadvantages, the potential scope of a 
bilingual labeling requirement, and costs. Specific questions the 
Agency would like the public to consider and respond to on this topic 
are included below in Section II.G.

B. Current EPA Provisions Relating to Pesticide Labeling in Spanish or 
Other Languages

    Several current EPA regulations and guidance documents contain 
provisions relevant to the issues raised by the petition. As stated in 
40 CFR 156.10(a)(3), ``All required label or labeling text shall appear 
in the English language. However, the Agency may require or the 
applicant may propose additional text in other languages as is 
considered necessary to protect the public. When additional text in 
another language is necessary, all labeling requirements will be 
applied equally to both the English and other-language versions of the 
labeling.''
    Currently, the Agency allows a pesticide registrant to add labeling 
in languages other than English. The Office of Pesticide Program's 
first statement of policy regarding bilingual labeling occurred in 
Pesticide Registration (PR) Notice 88-06. PR 88-06 was revised by PR 
95-2 and PR 98-10. All PR Notices can be found at http://www.epa.gov/PR_Notices/. PR 98-10 states, ``A registrant may provide bilingual 
labeling on any product without notification. The foreign text must be 
a true and accurate translation of the English text. Note: Both 
language versions of the labeling must appear on a container. Foreign 
text may be used on all or part of the labeling.''
    For pesticide products subject to the agricultural Worker 
Protection Standard (WPS) (40 CFR part 170), EPA requires that certain 
portions of the pesticide label contain words or phrases in Spanish. 
EPA regulations at 40 CFR 156.206(e) state:

    Spanish warning statements. If the product is classified as 
toxicity category I or toxicity category II according to the 
criteria in 156.62, the signal word shall appear in Spanish in 
addition to English followed by the statement, ``Si usted no 
entiende la etiqueta, busque a alguien para que se la explique a 
usted en detalle. (If you do not understand the label, find someone 
to explain it to you in detail.)'' The Spanish signal word 
``PELIGRO'' shall be used for products in toxicity category I, and 
the Spanish signal word ``AVISO'' shall be used for products in 
toxicity category II. These statements shall appear on the label 
close to the English signal word.

    Agricultural handlers are the agricultural employees responsible 
for mixing, loading, and applying pesticides. EPA requires that before 
the handler performs a handling activity, the handler employer ensures 
that the handler has either read the product labeling or has been 
informed, in a manner the handler can understand, of all labeling 
requirements related to safe use of the pesticide. EPA regulations at 
40 CFR 170.232(a)(1) state:

    The handler employer shall assure that before the handler 
performs any handling activity, the handler either has read the 
product labeling or has been informed in a manner the handler can 
understand of all labeling requirements related to safe use of the 
pesticide, such as signal words, human hazard precautions, personal 
protective equipment requirements, first aid instructions, 
environmental precautions, and any additional precautions pertaining 
to the handling activity to be performed.

    These requirements were established to better protect agricultural 
pesticide handlers covered by the WPS as they mix, load, and apply 
pesticides.

C. Languages Spoken in the United States and by Agricultural Handlers

    The Agency recognizes that residents of the United States speak 
many languages, with a significant proportion of the population being 
Spanish-speakers. A recently published U.S. Census Bureau American 
Community Survey report, Language Use in the United States: 2007, found 
that of the 281 million people in the United States aged 5 and over, 
55.4 million people (20% of this population) spoke a language other 
than English at home. Of these 55.4 million people, 62% (34.5 million) 
spoke Spanish. For comparison, the second most frequently spoken 
language was Chinese, with 2.5 million speakers, or 4.5% of people who 
speak a language other than English at home. Of the 34.5 million people 
who speak Spanish at home, 52.6% reported that they speak English 
``very well,''

[[Page 17609]]

18.3% reported that they speak English ``well,'' 18.4% reported that 
they speak English ``not well,'' and 10.7% reported that they speak 
English ``not at all'' (Shin, Hyon B. and Robert A. Kominski. 2010. 
Language Use in the United States: 2007, American Community Survey 
Reports, ACS-12. U.S. Census Bureau, Washington, DC).
    Data from the Department of Labor's National Agricultural Workers 
Survey (NAWS) show that many agricultural handlers (agricultural 
employees responsible for mixing, loading, and applying pesticides) 
have limited ability to read English. Over a three-year period, NAWS 
surveyors conducted nearly 6000 interviews across thirty-one states. 
Sixteen percent of the respondents identified themselves as 
``handlers,'' that is, crop workers who had mixed, loaded, or applied 
pesticides in the previous twelve months. Fifty-three percent of 
handlers report their dominant language as Spanish, and 46% of handlers 
said that their dominant language is English. Of the handlers whose 
dominant language was Spanish, 13% reported that they read English 
``well,'' 11% reported that they read English ``somewhat,'' 33% 
reported that they read English ``a little,'' and 43% reported that 
they read English ``not at all.'' In contrast, 65% of handlers whose 
dominant language was Spanish reported that they read Spanish ``well.'' 
(National Agricultural Workers Survey, public data for 1989-2009: 
http://www.doleta.gov/agworker/naws.cfm). There may be bias in these 
data, as it has been noted that self-reported estimates of reading 
skills may be biased towards the high-end, as people often overstate 
their abilities in interviews (Donaldson, Stewart I. Understanding 
Self-Report Bias in Organizational Behavior Research, Journal of 
Business and Psychology, Vol. 17, No. 2, Winter 2002).
    The National Agricultural Workers Survey reports that the average 
highest grade of education for all handlers (both Spanish and English-
speaking) was tenth grade. A 1994 study, published in the Journal of 
the American Optometric Association, found that an 11th grade cognitive 
reading level is required to understand a pesticide label. This 
suggests that although handlers may be relatively skilled Spanish 
readers, they may not be able to fully comprehend the label material.

D. Current EPA Initiatives Focused on Environmental Justice as It 
Pertains to Spanish Speakers in the United States

1. Consumer Protection
    People apply pesticides in and around their homes to control a 
variety of pests. One type of product used is total release foggers, 
also known as ``bug bombs.'' These pesticide products contain aerosol 
propellants and release their contents as a concentrated spray to 
fumigate an area. To ensure adequate protection of human health and the 
environment with respect to fogger use, EPA is working with 
stakeholders to make improvements to these product labels, including 
the use of plain language, the addition of pictograms and door hang-
tags, and the provision that certain label statements appear in Spanish 
as well as English.
2. Agricultural Worker Protection
    Agricultural workers can be exposed to pesticides through their 
work activities. These include farm workers, who cultivate and harvest 
crops treated with pesticides, and agricultural pesticide handlers, who 
mix, load and apply pesticides to protect crops. The WPS provides 
protections for both agricultural workers and handlers. For farm 
workers, who are exposed to pesticides through contact with treated 
crops but do not handle pesticides directly, the WPS establishes rules 
that agricultural employers must follow to minimize risks from 
pesticide exposure, such as those discussed in Section II B.

E. Activities of Other Regulatory Entities

    The state of California reviews all marketed labels as they appear 
on the container, whereas EPA reviews a text-only version of the label 
that contains all approved information but not necessarily in the 
format in which it will be presented in the marketplace. Some marketed 
labels include full Spanish translations for home garden products or 
antimicrobial products, and all agricultural pesticides under the 
purview of the WPS include the required WPS Spanish statements (40 CFR 
156.206(e)).
    In Puerto Rico, restricted use pesticides (RUPs) and pesticides 
registered to meet Special Local Needs (SLNs) must include labeling in 
Spanish (Puerto Rico Pesticide Act Part II, Section 4(D)(6)(a) and Part 
II Section 4(G)(3)). The pesticide dealer is required to provide the 
supplemental Spanish labeling to the buyer. The following portions of 
the label are required to be translated into Spanish:
    1. The precautionary statement, ``Keep out of reach of children;''
    2. Precautionary statements to prevent injury to humans, vertebrate 
animals, useful vegetation, and useful invertebrate animals, among 
others, and those statements required by the WPS, Endangered Species 
Act, and other statutes;
    3. Directions for use; and
    4. Pesticide use classification.
    In Canada, all pesticide products produced or sold domestically 
require labels in both English and French.

F. Potential Scope of This Initiative

    In considering this petition for bilingual labeling, the Agency is 
assessing the potential scope of such a requirement. EPA is considering 
whether the proposed bilingual labeling would improve safety and what 
potential effects it might have on industry and the enforcement 
community. Labels in English and Spanish could be required for all, or 
a subset of, pesticide products. Below are some potential options for 
bilingual labeling.
    1. Certain types of pesticide products: Bilingual labeling could be 
required for agricultural pesticide products, consumer pesticide 
products, fumigant products, or some other classification of product.
    2. Certain use sites: If it is determined that labeling in Spanish 
would be beneficial for a specific use site or commodity, products used 
on that use site could be required to have bilingual labeling.
    3. Products containing particular active ingredients: Another 
option could be to require the products with certain active ingredients 
to have labeling in Spanish; therefore, all products containing 
chemical X could require bilingual labels.
    4. Products of particular acute toxicity categories: Products with 
more toxic acute toxicity categories (Categories I or II) could require 
bilingual labeling.
    5. Either entire labels or portions of pesticide product labels 
could be required in English and Spanish. For example, the Directions 
for Use section of the product labeling could be required to be 
bilingual, or labeling statements dealing with worker protection, such 
as the personal protective equipment labeling, could be required to be 
in both Spanish and English. Other portions of the label that could be 
required to be in both languages include the general labeling 
requirements, the ingredient statement, precautionary labeling, 
environmental hazards, physical/chemical hazards, labeling claims, and 
company name and address, among others.

[[Page 17610]]

    The Agency acknowledges that there could be disadvantages or 
unintended consequences to a bilingual label recommendation or 
requirement, and invites public comment on the petition. The State 
FIFRA Issues Research and Evaluation Group (SFIREG) Pesticide 
Operations and Management (POM) committee submitted a letter to EPA in 
December 2010 outlining several concerns the committee has regarding 
the inclusion of labeling in Spanish on pesticide products. The 
December 2010 SFIREG POM letter is available in the docket. EPA is 
dedicated to working with SFIREG and all stakeholders to obtain 
information that will inform a decision on the petition for Spanish 
labeling of pesticide products.

G. Questions for Public Comment

    EPA invites all members of the public to post comments on this 
Notice and the petition it addresses. Specifically, EPA would like the 
commenter to address the following questions. EPA also invites all 
interested parties to comment on any other aspects of this petition's 
proposal that are not directly addressed by a question below.
    For the General Public:
    1. Language characteristics vary by culture, region, and other 
factors. How could EPA ensure that Spanish text on pesticide product 
labels would be understood by all potential Spanish-speaking users?
    2. Labeling in Spanish could potentially be required for all 
pesticide products, for a subset of pesticide products, or for a 
portion of the product label as described in section II.F. If the 
Agency concluded that translation of a portion or portions of the label 
were appropriate, which portions of the pesticide label would it be 
most beneficial to have in Spanish, and why? If the Agency were to 
limit the requirement for translation to only certain products, which 
products should be considered, and why? (Note: Please see the sample 
label in the docket to consider the different sections of a pesticide 
label.)
    3. Are there languages other than Spanish and English that EPA 
should consider for inclusion on pesticide labels? Which languages? 
Please explain your reasoning for including a language other than 
Spanish or English on pesticide labels, and cite documents that would 
further bolster your suggestion.
    For People Exposed to Pesticides:
    Farm workers, lawn and landscape maintenance workers, structural 
pest control technicians, commercial and residential cleaning staff, 
residential users of pesticides, children, pregnant or nursing women, 
older adults, others and advocacy groups:
    4. Please describe how having labels available in English and 
Spanish could increase or decrease pesticide user safety.
    5. How do you currently obtain information in Spanish regarding a 
pesticide product?
    6. Please describe how farm workers, their families, and others 
exposed to pesticides could benefit from this proposal.
    7. Would this proposal affect your day-to-day work? If so, how?
    8. Which parts of pesticide labeling, if any, would be most 
valuable to have translated into Spanish, and why? (Note: Please see 
the sample label in the docket to consider the different sections of a 
pesticide label.)
    9. Would having a Spanish translation of labeling be more important 
for some types of products than for others? Please describe why this 
would be so. And if so, how should EPA select products that would bear 
bilingual labeling?
    10. What effect would the availability of bilingual labeling have 
on users' understanding of label text?
    11. Would pictograms or other non-language methods of communication 
be beneficial for communication of labeling requirements?
    For Industry:
    12. Do you currently sell or distribute any pesticides with Spanish 
labeling (other than as required by 40 CFR 156.206)? If so, why have 
you decided to do so and what effects has the use of Spanish labeling 
had on the marketing or safety of using these products? Can you 
quantify or give examples of any added costs or benefits that have 
resulted from providing your products' labels in English and Spanish?
    13. What additional economic costs and/or benefits would you 
anticipate from having your products' labels available in Spanish as 
well as English? Costs might include translation, printing, or 
packaging. Benefits might include improved market penetration or 
improved customer good will. Besides any increased monetary costs, 
would there be other obstacles to printing bilingual labeling on your 
pesticide products?
    14. How could electronic media be used to facilitate distribution 
of bilingual or multilingual labeling?
    15. Apart from bilingual labeling, what past and current efforts 
have you made to communicate with customers or potential pesticide 
users who do not speak or read English fluently? What have you found to 
be effective or ineffective?
    16. If you provide Spanish labeling, do you provide it on products 
nation-wide or only in targeted regions? Why?
    17. How could EPA implement the petitioners' proposal or a version 
of it efficiently and equitably?
    18. Please explain whether there are any portions of a product's 
labeling that would not need to appear in both languages.
    For the State Pesticide Regulatory Community and the Enforcement 
Community:
    19. Are there state or local laws that conflict with the proposed 
bilingual labeling?
    20. What potential benefits or obstacles would a federal 
recommendation or requirement for bilingual labeling pose to the state 
regulation of pesticide products?
    21. What potential benefits would bilingual labeling provide and 
what potential costs or obstacles would bilingual labeling pose to 
enforcement activities?
    22. Do you know of any inspection or enforcement actions involving 
bilingually labeled products where the existence of two languages on 
the label has compromised bringing the action to closure?
    23. Do you know of any enforcement actions that have been taken 
because of, or compromised by, inaccuracies in labeling translation?
    24. Do you know of misuse incidents, poisonings, or other mishaps 
for which the lack of availability of bilingual labels may have been a 
contributing factor?
    25. Would a requirement that pesticides bear bilingual labeling 
increase or decrease the ability of people to use pesticides safely and 
effectively? Why?
    26. If pesticide products are required to carry labeling in 
Spanish, what effects, if any, would you anticipate on state pesticide 
applicator certification programs?

List of Subjects

    Environmental justice, environmental protection.

    Dated: March 17, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2011-6884 Filed 3-29-11; 8:45 am]
BILLING CODE 6560-50-P