[Federal Register Volume 74, Number 245 (Wednesday, December 23, 2009)]
[Proposed Rules]
[Pages 68215-68223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30408]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 156

[EPA-HQ-OPP-2009-0635; FRL-8803-3]
RIN 2070-AJ62


Public Availability of Identities of Inert Ingredients in 
Pesticides

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Advance notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY:  In response to two petitions seeking disclosure of selected 
inert ingredients on pesticide labels, based on hazard, EPA is 
initiating rulemaking to increase public availability of the identities 
of the inert ingredients in pesticide products. This action would 
assist consumers and users of pesticides in making informed decisions 
and reduce the presence of potentially hazardous ingredients in 
pesticides.

DATES:  Comments must be received on or before February 22, 2010.

ADDRESSES:  Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0635, 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-
2009-0635. 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 website 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

[[Page 68216]]

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:  Kerry B. Leifer, Registration 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: (703) 308-8811; fax number: (703) 605-0781; e-mail 
address: leifer.kerry@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you engage in 
activities related to the registration of pesticide products. 
Potentially affected entities may include, but are not limited to, 
engaging in the formulation and preparation of agricultural and 
household pest control chemicals or pesticide and other agricultural 
chemical manufacturing (NAICS) code 32532.
    You may also be affected by this action if you are a consumer or 
user of pesticides, or if you are exposed to pesticides.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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 why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    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. Discussion

A. What Action is the Agency Taking?

    EPA is seeking comment on options for increasing the public 
availability of the identities of inert ingredients in pesticides 
registered under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), 7 U.S.C. 136 et seq. This action is in response to two 
petitions filed in 2006 that identified a set of over 350 pesticide 
inert ingredients as hazardous and requested that EPA act to require 
that these inert ingredient identities appear on the labels of products 
that include these ingredients in their formulations (Refs. 1 and 2).
    On September 30, 2009, EPA partially granted the petitions, 
committing to initiate rulemaking to increase the public availability 
of the identities of inert ingredients (beginning with this ANPR), but 
seeking comment on a range of options to achieve this goal (Ref. 3.)

B. Background

    1. Statutory background. In enacting FIFRA, Congress chose to 
distinguish between active and inert ingredients in pesticides. Section 
2(a)(1) defines ``active ingredient'' to include an ingredient ``which 
will prevent, destroy, repel, or mitigate any pest.'' Section 2(m) 
defines ``inert ingredient'' as an ingredient which is ``not active.''
    FIFRA does not directly regulate active and inert ingredients per 
se. Rather, by means of a registration process, the statute regulates 
the sale, distribution, use and labeling of the pesticide products 
(often referred to in shorthand as ``pesticides'') that contain these 
ingredients. An applicant who seeks to register a pesticide must 
demonstrate that, among other things, ``when used in accordance with 
widespread and commonly recognized practice it will not generally cause 
unreasonable adverse effects on the environment.'' FIFRA section 
3(c)(5)(D). An applicant who seeks to register a pesticide must also 
submit or cite test and other data to demonstrate the safety (and in 
some cases the efficacy) of the pesticide. See FIFRA section 3(c)(1)(F) 
and 40 CFR part 158. Among other information, EPA requires a complete 
description of the composition of a pesticide formulation, including 
the identity of each active ingredient, intentionally added inert 
ingredient, each impurity present in an amount greater than 0.1% of the 
technical grade material, and each other impurity of toxicological 
significance.
    In order to determine if a pesticide product meets the unreasonable 
adverse effects standard, EPA conducts risk assessments for pesticide 
products in accordance with guidelines developed by the National 
Academy of Sciences (NAS)/National Research Council (NRC). The NRC risk 
assessment guidelines consist of four general steps:

[[Page 68217]]

Hazard identification, dose-response assessment, exposure assessment, 
and risk characterization. In the case of an inert ingredient, 
information on its hazard (the ability to cause adverse health and/or 
environmental effects) informs the risk assessment process but by 
itself is not sufficient to determine the risk (the likelihood that an 
adverse health effect will result from exposure) associated with a 
particular product.
    Active ingredients must be identified by name and percentage on the 
pesticide's ingredient statement, which is a necessary component of the 
pesticide product label under FIFRA section 2(q)(2)(A). By contrast, 
only the total percentage of all inert ingredients in the pesticide 
must be contained on the ingredient statement. FIFRA section 2(n)(1). 
There is no statutory requirement that the names of all inert 
ingredients be contained on the ingredient statement.
    Confidentiality of information submitted under FIFRA is governed by 
section 10 (with additional provisions in sections 7 and 12). With 
certain limited exceptions, FIFRA section 10(b) bars EPA from 
disclosing information ``which in the Administrator's judgment contains 
or relates to trade secrets or commercial or financial information 
obtained from a person and privileged or confidential.''
    Among the exceptions to confidentiality in section 10 is the 
requirement in FIFRA section 10(d)(1) to make safety and efficacy data 
available to the public. Safety and efficacy data constitute much of 
the information provided to EPA to support pesticide registration.
    Though FIFRA section 10(d)(1) is important to public understanding 
of the risks and benefits of specific pesticides, the provision is 
sometimes misunderstood in its effect on the confidentiality of inert 
ingredients. Section 10(d)(1) excludes three categories of information 
from the mandatory disclosure requirement for health and safety data:
    (A) manufacturing or quality control processes, (B) methods for 
testing, detecting, or measuring the quantity of inert ingredients, 
and (C) the identity or percentage quantity of inert ingredients.

The FIFRA section 10(d)(1)(C) exclusion for inert ingredient 
information has been taken by some to mean that any disclosure of inert 
ingredients is prohibited by statute, regardless of whether the 
information meets the confidentiality test in FIFRA section 10(b), but 
in fact the information must meet the FIFRA section 10(b) standard in 
order to be eligible for confidential treatment. See Northwest 
Coalition for Alternatives to Pesticides (NCAP) v. Browner, 941 F. 
Supp. 197, 201 (D.D.C. 1996).
    FIFRA section 12(a)(2)(D) provides authority for limited 
disclosures of confidential information, such as to medical 
professionals for evaluation and treatment purposes.
    2. EPA treatment of inert ingredient identities. Even with the 
limitations on confidentiality in section 10 of FIFRA, EPA is required 
by its confidentiality regulations at 40 CFR part 2, subpart B to 
protect information claimed as confidential until and unless the Agency 
makes a final determination that the information is not entitled to 
confidentiality. Moreover, under certain circumstances, if EPA 
possesses information for which an affected business might be expected 
to assert a confidentiality claim if it knew EPA proposed to disclose 
it, EPA must contact the submitter regarding any possible 
confidentiality claims prior to public release of the information. See 
40 CFR 2.204(c)(2); 2.201(d).
    Inert ingredient identities are often claimed as confidential by 
pesticide applicants and registrants. In addition, registrants often 
include in pesticide formulations proprietary inert ingredients or 
proprietary mixtures of inert ingredients whose identities are not 
disclosed to the registrants by the manufacturers of these products. 
The complete chemical identities of proprietary inert ingredients and 
proprietary mixtures of inert ingredients are reported to EPA by the 
manufacturers rather than by the registrants, and EPA normally does not 
disclose these identities to the registrants.
    Therefore the identities of inert ingredients are often difficult 
for pesticide users and other interested persons to obtain. Pesticide 
registrants may in certain circumstances be willing to provide such 
information directly to those who ask for it, and EPA, when necessary, 
provides inert ingredient information to medical professionals treating 
persons in connection with exposure to a pesticide in accordance with 
FIFRA section 12(a)(2)(D), as discussed previously. Nonetheless, the 
identities of inert ingredients in pesticides are not as a matter of 
course available to consumers in the way that, for example, cosmetic 
ingredients are disclosed.
    In some cases, however, EPA has determined that in order to meet 
the requirements of FIFRA certain inert ingredient identities must be 
disclosed on the labels of products in which they are present. In 1975, 
EPA promulgated 40 CFR 156.10(g)(7), which provides that ``[t]he 
Administrator may require the name of any inert ingredient(s) to be 
listed in the ingredient statement if he determines that such 
ingredient(s) may pose a hazard to man or the environment.'' When the 
provision was promulgated (originally as 40 CFR 162.10(g)(7)), EPA 
discussed the provision as implementing ``the Administrator's basic 
obligation under the amended FIFRA of determining the risks which may 
be posed by a pesticide and imposing the necessary regulatory 
requirement to adequately control an unreasonable risk. Depending on 
the risk involved, the Administrator is authorized by the amended FIFRA 
to: (1) Deny registration or cancel an existing registration, (2) 
classify the pesticide for restricted use, or (3) require specific 
label statements.'' (40 FR 28252, July 3, 1975).
    Additionally, in 1987, EPA published a Federal Register notice (52 
FR 13305, April 22, 1987) announcing ``certain policies designed to 
reduce the potential for adverse effects from the use of pesticide 
products containing toxic inert ingredients.'' This notice announced, 
among other things, that the identities of ``inerts of toxicological 
concern,'' otherwise known as List 1 inert ingredients, would be 
required to be listed on pesticide labels. Approximately 50 ingredients 
were put onto List 1, based on data demonstrating ``carcinogenicity, 
adverse reproductive effects, neurotoxicity or other chronic effects, 
or developmental toxicity (birth defects)'' as well as ``ecological 
effects and the potential for bioaccumulation.'' The notice also 
indicated that EPA intended to require the registrants of products 
containing List 1 ingredients to generate additional data to support 
the continued registration of the products. After publication of the 
notice, most List 1 ingredients disappeared from pesticide 
formulations. The notice created additional categories of inert 
ingredients, including List 2 ingredients, ``which the Agency believes 
are potentially toxic and should be assessed for effects of concern. . 
. .Many of these inert ingredients are structurally similar to 
chemicals known to be toxic; some have data suggesting a basis for 
concern about the toxicity of the chemical.''
    3. Petitions for disclosure of inert ingredients. In August 2006, 
EPA received two similar petitions, one from a group of 22 non-
governmental organizations (NGOs) and the other from the Attorneys 
General of 15 U.S. States and territories. These petitions identified 
inert ingredients that were contained within the categories listed 
later in this section, which the

[[Page 68218]]

petitioners stated were indicators that the inert ingredients met the 
standard for 40 CFR 156.10(g)(7) and should therefore be required to be 
listed on pesticide labels. The NGO petition argued, among other 
things, that disclosing inert ingredients that may be hazardous ``is in 
the public interest by supporting the public's ability to make informed 
consumer decisions, enabling faster and more accurate medical diagnoses 
after exposure to pesticides, and providing an incentive for 
manufacturers to use less toxic ingredients.'' Similarly, the state 
petition stated that ``EPA should require that pesticide product labels 
disclose the identity of all hazardous ingredients used in the 
formulation of the product, for whatever purpose they are used in that 
product, in order to adequately protect the public and fulfill the 
purposes of FIFRA.''
Following are the categories specified in the petitions:
     Organic pesticide active ingredients listed in 40 CFR part 
455, Table 1, in conjunction with section 304 of the Clean Water Act 
(CWA).
     Inert ingredients on List 2.
     Extremely Hazardous Substances - Emergency Planning and 
Community Right-to-Know Act (EPCRA) section 302(a).
     Chemicals on the Toxics Release Inventory (TRI)--EPCRA 
section 313.
     Chemicals regulated under section 6 of the Toxic 
Substances Control Act.
     Listed and characteristic wastes regulated under the 
Resource Conservation and Recovery Act and EPA regulations at 40 CFR 
part 261, including F, P, and U wastes.
     Chemicals regulated under CWA section 311: Discharges to 
navigable waters or adjoining shorelines.
     Chemicals regulated under CWA section 307: Pretreatment 
standards for indirect dischargers whose waste water passes through 
publicly owned treatment plants.
     Chemicals regulated under Clean Air Act (CAA) section 112: 
Hazardous air pollutants.
     Chemicals regulated under CAA section 112(r): Substances 
known to cause death, injury, or serious adverse effects to human 
health or the environment.
     Chemicals regulated under CAA section 202(a): Motor 
vehicle pollutants.
     Chemicals designated as hazardous mixtures consistent with 
section 101(14) of the Comprehensive Environmental Response, 
Compensation, and Liability Act (CERCLA).
     Chemicals designated under CERCLA section 104(i)(2) as 
priority list chemicals.
     Chemicals subject to the Occupational Safety and Health 
Administration's (OSHA) Occupational Safety and Health Standards at 29 
CFR part 1910.
     Chemicals contained in the American Conference of 
Governmental Industrial Hygienists' Threshold Limit Values for Chemical 
Substances and Physical Agents in the Work Environment (see http://www.acgih.org/TLV/PolicyStmt.htm).
    On September 30, 2009, EPA partially granted the petitions by 
committing to initiate rulemaking to broaden the public availability of 
inert ingredient identities but reserving the scope and details of such 
rulemaking. The Agency agrees with the petitioners that inert 
ingredient disclosure should be greatly increased (EPA's policy 
considerations are discussed in this document), and believes that 
rulemaking is the most practical and efficient means to bring about 
such disclosure. Because there remain a number of significant questions 
regarding the scope and nature of such disclosure, as well as the means 
by which such disclosure should be achieved, and because the changes 
involved will require significant input from persons that could be 
affected by such a rule, the Agency is initiating this rulemaking via 
an ANPR.
    4. Current efforts to increase public availability of the 
identities of ingredients in consumer products. EPA's efforts to 
increase public availability of the identities of ingredients in 
consumer products build on the substantial work done by the Inert 
Disclosure Stakeholder Workgroup (IDSW) which has helped shape the 
Agency understanding of the complex nature of inert disclosure issues. 
In 1999, the Pesticide Program Dialogue Committee (PPDC, established 
under the Federal Advisory Committee Act to advise EPA regarding 
pesticide matters) approved the establishment of the subgroup, the 
IDSW, a diverse workgroup of members from public health, environmental, 
industry, academic and state government organizations, as well as EPA, 
to create proposals for submission to the PPDC regarding enhanced 
disclosure to the public of information about inert ingredients in 
pesticides products. (This examination was spurred in part by earlier 
petitions from essentially the same groups of petitioners regarding 
disclosure of inert ingredients.)
    The IDSW compiled a final report in 2002 (Ref. 4). This report 
helped the Agency identify target audience groups and their 
informational needs regarding inert ingredients, documented several 
different proposals to enhance inert disclosure, and published position 
papers covering topics such as reverse engineering, response to medical 
emergencies, ingredient information readily available to the medical 
community, identification of inert ingredients, and labeling changes. 
The final report also discusses other Federal regulatory schemes for 
handling the confidentiality of ingredient information implemented by 
the Food and Drug Administration, OSHA, and the Consumer Product Safety 
Commission.
    The IDSW discussions and final report continue to inform the Agency 
as EPA contemplates rulemaking to increase public availability of inert 
ingredients.
    5. Problem statement. EPA believes that the lack of information 
available to consumers and users about the inert ingredients in 
pesticide products results in a market failure that causes pesticide 
products to contain inert ingredients that are more hazardous than is 
efficient. Consumers may prefer to use pesticide products with non-
hazardous inert ingredients. In general, however, pesticide producers 
currently do not publicly disclose the identities of inert ingredients. 
Consequently, consumers cannot base their decisions about which 
pesticides to use or whether the pesticides contain hazardous inert 
ingredients. If this information were available, it could influence 
consumers' decisions on which pesticides to purchase and use. Moreover, 
if consumers prefer pesticides without hazardous inert ingredients, 
their ability to choose such pesticides would create incentives for 
producers of pesticide products to offer products without hazardous 
inert ingredients. The current lack of information about inert 
ingredients interferes with the fair and efficient functioning of the 
market by adversely affecting consumers' ability to exercise individual 
choice or express preferences and thus the market-driven incentives for 
producers and suppliers of pesticide products. As a result, pesticide 
products may contain levels of hazardous ingredients that are higher 
than society needs or wants and/or people may use a pesticide product 
or combination of products that lead to more adverse health or 
environmental outcomes than would otherwise occur.
    In this section, the use of the term ``consumer'' is not intended 
to limit this discussion to individuals purchasing or using pesticide 
``consumer products'' that are marketed for residential use but also 
includes consumers of other kinds of pesticide products such as those 
used in agricultural and institutional settings. As such, the term goes 
beyond the usual point-of-sale consumer to include a

[[Page 68219]]

wide range of individuals, entities and organizations that purchase or 
use different kinds of pesticide products. This wide range of 
consumers, represent a complex and diverse range of knowledge and 
understanding about pesticides. Consumer knowledge is not limited to an 
individual's understanding of specific chemicals. Such knowledge may be 
supplemented via training, websites or other independent sources of 
pesticide information. In addition, purchasers or users of pesticides 
for agricultural and institutional settings often rely on 
organizational knowledge and preferences to inform their decisions.
    There is an overall societal benefit from individual choice. This 
is one reason that legislation has favored informing consumers about 
products in commerce through product labeling. For example, the Fair 
Packaging and Labeling Act, 15 U.S.C. 1450 et seq., states that 
``Informed consumers are essential to the fair and efficient 
functioning of a free market economy.'' (Ref. 6). When consumers are 
knowledgeable about the product choices available to them, they are 
better able to compare the products and vote with their pocketbook by 
selecting that product which best satisfies their needs and/or 
preferences. For example, consumers of pesticide products may have 
specific preferences related to reducing potential exposures to 
chemicals due to allergies or concerns over potential hazards to human 
health or the environment.
    Increased public disclosure of inert ingredients in pesticides, 
particularly hazardous inert ingredients, could enable consumers and 
users of pesticides to make more informed decisions when choosing or 
using pesticide products. It could also provide important information 
regarding the use of a pesticide, potentially enabling the consumer to 
avoid choosing a particular product to use in a situation where one or 
more of the inert ingredients might have an adverse health or 
ecological impact (e.g., using a pesticide containing a specific inert 
ingredient where a person with a known sensitivity to that ingredient 
might be exposed to the product, or where the inert ingredient might 
adversely affect non-target organisms).
    By interfering with the consumers' ability to fully express their 
preferences through informed purchasing, the lack of information on 
inert ingredients in pesticide products also adversely affects the 
potential for market-driven incentives for pesticide producers to 
provide products that better meet the needs and/or preferences of the 
consumer. For example, where consumers that have a preference for 
pesticide products with less hazardous inert ingredients are able to 
fully express that preference, pesticide producers have a market-based 
incentive to select less hazardous inert ingredients for the product 
formulations.
    Ultimately, by enabling more informed consumer choices, disclosure 
of inert ingredients in pesticides, particularly hazardous inert 
ingredients, may lead the market to provide more product choices that 
could reduce overall exposures to potentially hazardous chemicals. For 
example, public disclosure of the presence of a potentially hazardous 
inert ingredient in a specific pesticide formulation may lead to less 
exposure to that hazardous inert ingredient because consumers will 
likely choose products informed by the label and pesticide producers 
will likely respond by producing products with less hazardous inert 
ingredients. The ability of public disclosure of information as a 
market-driver to reduce the use of potentially hazardous chemicals has 
been demonstrated by publication of the TRI under EPCRA section 313 
(Ref. 5).
    On the other hand, mandatory inert ingredient disclosure could have 
potential negative effects on innovation in the pesticide market. 
Producers of pesticides invest in developing formulations that are 
effective. Public disclosure of ingredients could give competitors the 
ability to ``free ride'' on another company's investment in research 
and development required to bring a pesticide product to the market. 
The presence of such ``free riders'' could deter further investments 
needed to bring new, improved products to the market in the future. 
However, as discussed in Unit II.C.2., the Agency believes a closer 
examination of those circumstances under which confidentiality of inert 
ingredient identities is necessary for preserving manufacturers' 
returns to research and development investments will reveal situations 
where public availability of inert ingredient identities may occur 
without significant detriment to innovation in the pesticides market.
    EPA believes in the value of transparency to consumers and users of 
pesticides, above and beyond those issues pertaining to potentially 
hazardous inert ingredients. EPA is also mindful of potential ``label 
clutter,'' i.e., the inclusion of so much information in the labeling 
of a product that it becomes difficult for a user to find the relevant 
information necessary to use the pesticide safely, effectively, and 
legally.
    The Agency therefore wishes to explore what avenues are available 
to maximize the public availability of inert ingredient identities 
generally. In addition to the policy considerations raised in the 
discussion in Unit II.C., EPA is specifically interested in comments on 
the relationship of inert ingredient labeling to the fair and efficient 
functioning of the market.

C. Possible Approaches

    EPA is considering two general types of approaches to increasing 
public availability of inert ingredient identities. One would mandate 
disclosure only of potentially hazardous ingredients, and the other 
would promote or mandate public availability of most or all inert 
ingredient identities, regardless of hazard. Each approach has 
variations and issues associated with it. Further, EPA solicits ideas 
for alternative approaches, both regulatory and non-regulatory.
    1. Require the identities of potentially hazardous inert 
ingredients to be listed on pesticide labels. This approach involves 
identifying a set of potentially hazardous inert ingredients and 
amending labeling regulations in 40 CFR part 156 to require that 
pesticides containing those ingredients list them in the ingredient 
statement. There are a number of issues that would need to be resolved 
in order to implement this option; EPA solicits comment on these 
issues:
    a. How should the list of potentially hazardous ingredients be 
identified? EPA is interested in comments on three potential 
approaches.
    (1) EPA could by rule require disclosure of the identity of an 
ingredient if the ingredient appeared on specified lists; this is the 
approach advocated by the petitioners. The petitions identify a variety 
of statutory, regulatory, and other listings that relate in some way to 
hazard. Some of the ingredients have been placed on these listings by 
Congress, and some have been included based on EPA or other agency 
evaluations of hazard (which may or may not be in a specific exposure 
context).
    (2) EPA could by rule establish objective criteria for determining 
whether to require disclosure, applying those criteria on an 
ingredient-by-ingredient basis. Unit II.E. of this ANPR contains an 
example of possible criteria.
    (3) EPA could by rule list specific chemicals used as inert 
ingredients that would trigger a disclosure requirement. While approach 
number 2 would present criteria to use on a case-by-case basis, this 
approach would present a list of chemicals. In developing this list,

[[Page 68220]]

EPA could use approach number 1 or 2 or a combination of both 
approaches to identify the individual chemicals to include on the list 
and would need to identify a process for revisions to the list.
EPA considers the set of ingredients and categories identified in the 
petitions to be a useful starting point for discussion, but desires 
input regarding the categories and the chemicals contained within them. 
For example, should chemicals placed in the TRI by Congress be 
considered presumptively hazardous for purposes of label disclosure? In 
addition, EPA solicits suggestions for other hazard criteria to be used 
as a basis for identifying ingredients to be listed in the ingredient 
statement.
    b. How should specific ingredients be added to or removed from the 
disclosure requirements? EPA could add (or remove) individual 
ingredients via regulation, or, at least for those categories 
established and amended via statute or regulation, could simply require 
that all ingredients in the category be subject to the disclosure 
requirement. EPA desires comment on both science and process 
implications of these two alternatives, as well as additional ideas.
    c. Should EPA consider the amount of an ingredient in a product in 
determining whether to require disclosure, and if so how? Should there 
be a de minimis concentration, below which a potentially hazardous 
inert ingredient would not be required to appear in the ingredient 
statement? EPA is initially inclined not to use the quantity of an 
inert ingredient--including any de minimis threshold--as a factor in 
determining what information should be disclosed. EPA is concerned that 
using a quantity factor could interfere with the consumers' ability to 
fully express their choices through informed purchasing and thereby 
adversely affect the potential for market-driven incentives for 
pesticide producers to provide products with less hazardous inert 
ingredients. It could also compromise the consumers' ability to limit 
their total exposure to a hazardous substance. In providing comments on 
using a quantity factor, please also provide suggestions for how EPA 
might address these concerns.
    d. Does disclosing the identities of hazardous inert ingredients on 
the label without further information provide consumers and users with 
information that is useful? EPA is soliciting comments on additional 
disclosure approaches to provide such information, including the 
effectiveness of such an approach, as well as the associated costs and 
benefits. EPA also seeks comment as to the possible positive or 
negative impacts of each such approach on the development of new 
pesticide products, in providing for more informed consumer decision-
making, and in providing an incentive for manufacturers to use less 
hazardous inert ingredients.
    e. Should potentially hazardous impurities be required to appear on 
the label? While inert ingredients are intentionally added to a 
product, impurities are not. See 40 CFR 158.300. Impurities are often 
leftover reactants from the manufacturing process, and their disclosure 
thus might in some cases reveal sensitive manufacturing process 
information. What are the pros and cons of including impurities in a 
disclosure requirement? Should impurities have a de minimis 
concentration threshold, even if inert ingredients ultimately do not? 
Note that impurities below a concentration of 0.1% are not normally 
reported to EPA unless the impurity is of toxicological significance. 
See 40 CFR 158.320. Would a 0.1% threshold make sense for impurities? 
How should the Agency determine which impurities need to be identified 
on the label?
    2. Require all or most inert ingredients to be listed on pesticide 
labels. In addition to the hazard-based disclosure discussed 
previously, EPA is also interested in broader availability of inert 
ingredient identities. Many consumer products, such as food products 
and cosmetics and, to an increasing extent, other household products, 
disclose some information about their ingredients. The Agency believes 
that consumers and users of pesticides should have comparable kinds of 
ingredient information available to them about pesticides as they do 
regarding many other, often less hazardous products. Such information 
assists consumers in making informed choices.
    Requiring disclosure of all inert ingredients would be possible if 
inert ingredients as a class were not entitled to confidential 
treatment under FIFRA section 10(b). Though confidentiality is normally 
determined on a case-by-case basis, see NCAP v. Browner, 941 F. Supp. 
197 (D.D.C. 1996), EPA desires input on an issue pertinent to the 
confidentiality of inert ingredients in general. Among the factors in 
determining eligibility for confidential treatment is whether 
competitors could reverse engineer the product to obtain the 
information on their own, without undue cost. Though this question is 
itself normally answered on a case-by-case basis, EPA solicits comment 
regarding whether analytical techniques have increased in accuracy and 
decreased in cost to the extent that essentially complete analysis of 
competitors' products is now both routinely performed and successful 
when attempted in the pesticide industry.
    Do registrants and inert ingredient manufacturers know (or can they 
easily find out) what is in their competitors' products? Do they 
believe that their own products are safe from reverse engineering due 
to the limits of analytical techniques or prohibitive cost? To what 
extent do patents or other public sources of information provide this 
kind of information? Are there types of products or ingredients where 
reverse engineering is more or less likely to be performed or 
successful? Are there characteristics of a formulation (e.g., 
concentration of certain ingredients) that can make reverse engineering 
economically infeasible? Do other countries disclose this information 
and if so under what circumstances? When commenting on this issue 
please distinguish qualitative analysis (determining which ingredients 
are present) from quantitative analysis (determining the concentrations 
of ingredients). In addition, bear in mind the distinction between 
disclosure of the chemical name of an inert ingredient and disclosure 
of the identity of a particular vendor of the ingredient. Please also 
comment upon whether these questions would be answered differently for 
impurities.
    Are there classes or sectors where the identities of inert 
ingredients are generally known among competitors? The Agency assumes 
that there would be no substantial competitive harm from the disclosure 
of inert ingredients where the technology is generally known among 
competitors. EPA solicits comment on these questions.
    EPA is not only seeking input from knowledgeable persons regarding 
the factors that influence whether competitors are aware of one 
another's formulations, but is also challenging registrants and inert 
ingredient manufacturers to reexamine their own assumptions about the 
competitive landscape for their products. What role does 
confidentiality of inert ingredient identities play today in product 
competitiveness? Are there sectors of the industry where this role is 
enhanced or diminished?
    Even to the extent that particular inert ingredients are entitled 
to confidential treatment under FIFRA section 10(b), EPA can amend its 
regulations to increase the public availability of inert ingredient 
identities. As discussed previously, Agency practice results in sparse 
disclosure of inert ingredient

[[Page 68221]]

identities because there is seldom a clear indication up front of which 
ingredient identities are claimed as confidential. Where specific 
identities are not claimed as confidential by the registrant or inert 
ingredient manufacturer, EPA could make the information public without 
further analysis. EPA therefore solicits comment regarding whether the 
Agency should require the identities of all inert ingredients (and 
perhaps impurities) to be specifically claimed as confidential upon 
submission to the Agency, such that in the absence of a confidentiality 
claim the name will be required to appear on the label (or elsewhere) 
as discussed in Unit II.C.3.i.). EPA also solicits comment on requiring 
that all confidentiality claims for inert ingredient identities be 
accompanied by a substantiation of the confidentiality claim in order 
to help ensure that the confidentiality claims have substance. See 40 
CFR 2.204(e)(4) for EPA's standard substantiation questions. If EPA 
were to require up-front substantiation of confidentiality claims, what 
kinds of information in addition to the questions in 40 CFR 2.204(e)(4) 
would be of value to assess the merits of a confidentiality claim for 
inert ingredient information?
    EPA also notes some policy tension between the two approaches: 
Hazard-based disclosure is intended to reduce the prevalence of 
hazardous ingredients by highlighting their presence, and to the extent 
that the Agency achieves a broader (non-hazard-based) disclosure of 
inert ingredients, that highlighting would be absent. By knowing the 
ingredients in a product, motivated users and consumers could research 
the hazard, but this information would not be readily apparent simply 
from the ingredient list. EPA would appreciate comment on the 
interaction between these policy objectives.
    The following issues apply to broad public availability of inert 
ingredient identities:
    a. Are there classes of ingredients that should be identified only 
by the name of the class? Examples might be functional (e.g., 
fragrances, surfactants), a chemical class (e.g., clay, modified 
starch), or otherwise. When would the use of chemical classes be 
appropriate or inappropriate? Note that EPA is considering allowing 
substitution of fragrances in a formulation without requiring the 
reporting of the individual fragrance ingredients which comprise the 
fragrance, provided that the ingredients are on the Fragrance 
Ingredient List and that the fragrance meets concentration and other 
conditions in EPA's Fragrance Notification Program such as was 
described as part of the Pesticide Fragrance Notification Pilot Program 
(http://www.epa.gov/opprd001/inerts/fragrancenote.pdf).
    b. Should impurities potentially appear on the label regardless of 
hazard? See Unit II.C.1.e., for more discussion of impurities.
    3. Common issues. EPA also solicits comment on the following 
issues, which apply to both hazard-based and non-hazard-based 
disclosure:
    a. How might consumers respond to the disclosure approaches 
presented previously? Would there be any difficulty in interpreting the 
information? How would consumers judge risks from hazardous inert 
ingredients that have broader environmental impacts as opposed to risks 
that are borne more directly by the user? What evidence exists 
regarding how disclosure affects consumer decisions and market outcomes 
in similar contexts? How should disclosure be designed to achieve 
better user decision-making?
    b. If inert ingredients are required to be listed on the label, 
would consumers and users be able to weigh the risk from the listed 
inert ingredients against that from the active ingredients, which often 
pose greater risks than the disclosed inert ingredients? What steps 
would assist consumers and users in taking into account all risks posed 
by the pesticide?
    c. What are the possible positive or negative impacts of the 
approaches described in Unit II.C. on the development of new pesticide 
products?
    d. Should the concentration of ingredients be disclosed, along with 
their identities? How might the concentration inform the decision-
making of the consumer or user? Is there sufficient benefit to 
consumers and users to do so? What are the interests of registrants and 
manufacturers of proprietary inert ingredients and proprietary mixtures 
of inert ingredients in concentration information?
    e. Should inert ingredients be listed in order of concentration? 
Although specific concentrations are not provided for food products and 
cosmetics, the ingredients are typically listed in order of 
concentration as instructed at 21 CFR 101.4 and 21 CFR 701.3, 
respectively, under FDA regulations implementing the Federal Food, 
Drug, and Cosmetic Act. How might listing the inert ingredients in 
order of concentration inform the decision-making of the consumer and 
user? What would be the value of this type of listing for pesticide 
consumers and users? Could listing inert ingredients in order of 
concentration mislead consumers or users regarding the safety of the 
formulation?
    f. EPA has on occasion rejected pesticide labels with partial 
disclosure of inert ingredient identities as misleading under FIFRA 
section 2(q)(1)(A) on the theory that emphasizing ingredients widely 
considered innocuous can mislead consumers as to the overall safety of 
the formulation. What features of a label (or other disclosure) could 
help avoid this outcome?
    g. In PR Notice 97-6, http://www.epa.gov/opppmsd1/PR_Notices/pr97-6.html, EPA allowed and encouraged pesticide registrants to replace the 
designation ``inert ingredients'' with ``other ingredients'' on 
pesticide labels, because inert ingredients may in some cases be 
associated with hazard, and the term ``inert ingredients'' might 
therefore be confusing. Under a full or partial disclosure of inert 
ingredients, should EPA discontinue to allow the substitution of the 
term ``other ingredients'' for ``inert ingredients'' on product labels?
    h. Should inert ingredients continue to be listed in a separate 
location from active ingredients? Current EPA guidelines contained in 
the Label Review Manual specify that active ingredients be listed on 
the product label separately from inert ingredients. Should EPA 
preserve this distinction between inert and active ingredients? Should 
the inert ingredient listing be divided into hazardous and non-
hazardous sections?
    i. Should disclosure of the inert ingredient identities be made 
elsewhere than on the label, such as in accompanying labeling 
materials, by a registrant-operated toll free telephone system, or on 
an EPA-maintained website? What information would be useful to provide 
on a website? What other alternative ways of communicating information 
to users about ingredients and safety of pesticides might be effective? 
What are the advantages and disadvantages of such alternatives?
    j. Should unique procedures apply to products containing 
proprietary inert ingredients or proprietary mixtures of inert 
ingredients? Because registrants may not know the identity of a 
proprietary inert ingredient or the identities of all the ingredients 
in a proprietary mixture of inert ingredients, there may be 
confidentiality concerns when informing registrants of new requirements 
applying to their pesticide products, and such registrants might face 
additional barriers to adjusting to a

[[Page 68222]]

disclosure requirement. In addition, manufacturers of proprietary inert 
ingredients and proprietary mixtures of inert ingredients might raise 
confidentiality and other issues that do not apply to registrants.
    k. Should disclosure of the identity of inert ingredients apply to 
all types of pesticide products or should EPA exempt certain types of 
products, e.g., manufacturing use products, plant-incorporated 
protectants, biopesticides, products intended only for use in 
industrial settings such as wood preservative treatment facilities, 
from disclosure rules?
    l. What form of ingredient identity should appear on the label? 
There are a variety of ways to identify an ingredient, such as Chemical 
Abstracts Service (CAS) name, CAS Registry Number, trade name, and 
common chemical name (of which there may be several). Which form would 
be most useful to consumers and users of pesticides? See 40 CFR 
156.10(g) for requirements regarding common names for active 
ingredients, and Pesticide Registration (PR) Notice 97-5: Use of Common 
Names for Active Ingredients on Pesticide Labeling, http://www.epa.gov/opppmsd1/PR_Notices/pr97-5.html, for Agency policy and guidance.
    m. How would a non-regulatory approach, such as voluntary 
disclosure of inert ingredients by pesticide registrants, affect 
consumer decisions and market outcomes? What would be the advantages 
and disadvantages of voluntary disclosure versus required disclosure in 
considering the issues noted in items a. through l. of this unit?
    n. What lead time should be given before the effective date of any 
regulatory changes, and should there be any special process for 
approving new labels? Registrants and manufacturers of proprietary 
inert ingredients/proprietary mixtures of inert ingredients may wish to 
reformulate rather than continue with a formulation where potentially 
hazardous ingredients are listed in the ingredient statement. Since EPA 
normally requires acute toxicity data on each new formulation of a 
pesticide, any large-scale movement toward reformulation of pesticides 
could result in a significant amount of additional animal toxicity 
studies. Further, the logistics of widespread label change or possible 
product reformulation may present special challenges for EPA, States 
and the regulated community. What procedures would minimize disruption? 
Are there alternatives to requiring the testing of products 
reformulated to eliminate hazardous inert ingredients?
    o. Are there other regulatory approaches that may promote the use 
of less hazardous inert ingredients that might be considered in lieu of 
inert ingredient disclosure? For example, what would be the potential 
impacts on consumers, pesticide manufacturers, and the general public 
if EPA were to limit or prohibit the use of any hazardous inert 
ingredient in a pesticide product?

D. What is the Agency's Authority for Taking this Action?

    The authority to require public availability of potentially 
hazardous inert ingredients (on the ingredient statement or elsewhere) 
can be found in the registration requirements of FIFRA section 3, the 
definition of ``unreasonable adverse effects on the environment'' in 
FIFRA section 2(bb), and EPA's rulemaking authority under FIFRA section 
25(a). The safety of the formulation, including all its ingredients, is 
a critical factor in whether the pesticide ``will perform its intended 
function without unreasonable adverse effects on the environment.'' 
FIFRA section 3(c)(5)(C). Under FIFRA section 2(bb), the term 
``unreasonable adverse effects on the environment'' takes into account 
``the economic, social, and environmental costs and benefits of the use 
of any pesticide.'' The FIFRA section 2(bb) definition thus highlights 
cost/benefit comparisons pertaining to use of a particular pesticide in 
the consideration of its eligibility for registration.
    While there is no definition for hazardous inert ingredients in 
FIFRA (and this document asks for comment regarding how to define such 
ingredients for the purpose of this rulemaking), hazardous inert 
ingredients can in general be described as those that may pose physical 
hazards (e.g., flammability, explodibility), health hazards (i.e., 
adverse acute/chronic health effects), or environmental hazards (e.g., 
adverse ecological effects, persistence, bioaccumulation). Use of any 
pesticide will involve some exposure to persons and the environment, 
and if the formulation contains potentially hazardous inert ingredients 
there will be some exposure to those ingredients, and therefore some 
level of risk resulting from this exposure. And though EPA reviews data 
regarding the entire formulation to ensure that this risk of a 
particular pesticide is not unreasonable, formulations that contain 
hazardous inert ingredients as a general matter may have a less 
favorable cost/benefit ratio than similar formulations that perform the 
same function and do not contain potentially hazardous inert 
ingredients. Therefore, under FIFRA section 2(bb), any risk from 
hazardous ingredients, however small, should in general be less 
reasonable than the risk from a formulation not containing potentially 
hazardous ingredients, even though the risk from a particular 
formulation is not itself unreasonable so that the registration 
standard is met.
    EPA solicits comment on the contribution to risk from hazardous 
inert ingredients. For example, are there situations where the presence 
of a particular hazardous inert ingredient results in a lower 
application rate than could be achieved through the use of a less 
hazardous ingredient?
    EPA could address relative levels of risk on a case-by-case basis 
via label reviews, approvals of specific formulations, or even 
cancellation under FIFRA section 6 where appropriate, but such actions 
would be very slow and resource-intensive. It is more efficient to use 
the authority provided in FIFRA section 25(a)(1) ``to prescribe 
regulations to carry out the provisions of [FIFRA]. Such regulations 
shall take into account the difference in concept and usage between 
various classes of pesticides. . . and differences in environmental 
risk.'' EPA considers pesticides containing potentially hazardous inert 
ingredients to be in a separate class from formulations that do not 
contain such ingredients, and believes it appropriate to use its FIFRA 
section 25(a) rulemaking authority to take action to reduce the 
presence of potentially hazardous ingredients.
    As to requiring public availability of inert ingredients on a basis 
other than hazard, EPA has such authority where inert ingredient 
identities are not subject to claims of confidentiality or where such 
information is not entitled to confidential treatment under law.

E. Suggested Hazard Criteria

    The following are the suggested hazard criteria as discussed in 
Unit II.C.1.a. that could be used as a basis for identifying 
ingredients to be listed in the ingredient statement.

 
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Physical Hazards
------------------------------------------------------------------------
 
 Extremely flammable or combustible
 Explosive
 Pyrophoric
 Strong organic peroxide
 Strong oxidizer
Health Hazards
 
Acute Toxicity
 Acute oral, dermal, and/or inhalation toxicity study resulting
 in assignment to EPA Toxicity Category I (40 CFR 156.62)

[[Page 68223]]

 
 Skin corrosion
 Eye damage
 Strong skin and/or respiratory sensitizer
 
Mutagenicity
 Known to induce heritable germ cell mutations in humans
 Positive result(s) from in vivo heritable germ cell
 mutagenicity tests in mammals
 
Carcinogenicity
 Known or presumed human carcinogen
 Classified as: Group 1 or Group 2 by the International Agency
 for Research on Cancer (IARC); having evidence of carcinogenic activity
 by the National Toxicology Program (NTP) and/or the Environmental
 Protection Agency (EPA); and/or a Category I Potential Carcinogen by
 the Occupational Safety and Health Administration (OSHA)
 
Reproductive and Developmental Toxicity
 Known or presumed human reproductive or developmental toxicant
 Clear evidence of adverse effects on reproductive ability or
 capacity and/or development of the offspring in peer-reviewed
 experimental animal studies
 
Target Organ/Systemic Toxicity
 Causes hepatotoxicity, nephrotoxicity, neurotoxicity,
 hematopoetic effects, immunotoxic effects, pulmonary toxicity, thyroid
 toxicity, cutaneous toxicity or other specific target organ/systemic
 toxicity in peer-reviewed experimental animal studies at doses below 50
 mg/kg/day
 
Environmental Hazard
 Highly toxic to avian and mammals (acute oral toxicity <50 mg/
 kg) based on peer-reviewed studies
 Highly toxic to aquatic organisms at concentrations of 1 ppm or
 below based on peer-reviewed studies
 Highly toxic in avian dietary studies (<50 ppm) based on peer-
 reviewed studies
 Very slow biodegradation (<30% degradation in >28 days) in an
 EPA Office of Prevention, Pesticides and Toxic Substances (OPPTS)
 Harmonized Test Guideline Test 835.3110, Organisation for Economic Co-
 operation and Development (OECD) Guideline Test 301, or equivalent for
 biodegradability
 Partition coefficient (n-octanol/water) value (P) of log P >=4
 in OPPTS Harmonized Test Guideline 830.7550, OECD Guideline 117, or
 equivalent study
 Fish Bioconcentration Factor (BCF) of >=1,000 in OPPTS
 Harmonized Test Guideline 850.1730 (draft), OECD Guideline 305, or
 equivalent study
 Class I/Class II Ozone-depleting Substance or High Global
 Warming Potential Gas
------------------------------------------------------------------------

III. Statutory and Executive Order Reviews

    Under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993), this action was submitted to 
the Office of Management and Budget (OMB) for review. Any changes to 
the document that were made in response to OMB comments received by EPA 
during that review have been documented in the docket as required by 
the Executive Order.
    Since this document does not impose or propose any requirements, 
and instead seeks comments and suggestions for the Agency to consider 
in possibly developing a subsequent proposed rule, the various other 
review requirements that apply when an agency imposes requirements do 
not apply to this action. Nevertheless, as part of your comments on 
this document, you may include any comments or information that you 
have regarding the various other review requirements.
    In particular, EPA is interested in any information that would help 
the Agency to assess the potential impact of a rule on small entities 
pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.); to consider voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note); to 
consider environmental health or safety effects on children pursuant to 
Executive Order 13045, entitled ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997); or to consider human health or environmental effects on minority 
or low-income populations pursuant to Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    The Agency will consider such comments during the development of 
any subsequent proposed rule as it takes appropriate steps to address 
any applicable requirements.

IV. References

    1. Petition of New York, et al., Requesting that the United States 
Environmental Protection Agency Amend Its Rules Governing the 
Disclosure of ``Inert'' Ingredients on Pesticide Product Labels to 
Require the Disclosure of Ingredients for Which Federal Determinations 
of Hazard Have Already Been Made, August 2006.
    2. Petition of Northwest Coalition for Alternatives to Pesticides, 
et al., To Require Disclosure of Hazardous Inert Ingredients on 
Pesticide Product Labels, August 2006.
    3. EPA's Response to Petitions Requesting Disclosure of Inert 
Ingredients, September 30, 2009, http://www.epa.gov/opprd001/inerts/petitionresponse.pdf.
    4. Final Report to the Pesticide Program Dialogue Committee on the 
Activities of the Inert Disclosure Stakeholder Workgroup, March 2000 
through April 2002, http://www.epa.gov/oppfead1/cb/ppdc/inert-finalreport.html.
    5. How Are the Toxics Release Inventory Data Used? -- Government, 
business, academic and citizen uses. EPA-260-R-002-004 (May 2003), 
http://www.epa.gov/TRI/guide_docs/pdf/2003/2003_datausepaper.pdf.
    6. Fair Packaging and Labeling Act, 15 U.S.C. 1450 et seq. http://www.fda.gov/RegulatoryInformation/Legislation/ucm148722.htm.

List of Subjects in 40 CFR Part 156

    Environmental protection, Pesticides and pests.

    Dated: December 14, 2009.
Lisa Jackson,
Administrator.

[FR Doc. E9-30408 Filed 12-22-09; 8:45 am]
BILLING CODE 6560-50-S