[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]
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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.
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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: [email protected].
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