[Federal Register: March 24, 2008 (Volume 73, Number 57)]
[Rules and Regulations]
[Page 15421-15425]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr08-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 59
[EPA-HQ-OAR-2006-0971; FRL-8544-2]
RIN 2060-AO86
National Volatile Organic Compound Emission Standards for Aerosol
Coatings
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is taking direct final action to amend the National
Volatile Organic Compound Emission Standards for Aerosol Coatings final
rule, which is a rule that establishes national reactivity-based
emission standards for the aerosol coatings category (aerosol spray
paints) under the Clean Air Act, published elsewhere in this Federal
Register. This direct final action clarifies and amends certain
explanatory and regulatory text in the Aerosol Coatings final rule, as
the final rule contains misstatements and possibly confusing language
on how compounds are added to the list in Tables 2A, 2B or 2C--
Reactivity Factors, and when distributors and retailers are regulated
entities responsible for compliance with the final rule.
DATES: This direct final rule is effective on June 23, 2008, without
further notice, unless EPA receives adverse comment by April 23, 2008,
or May 8, 2008, if a public hearing is held. If EPA receives adverse
comment, we will publish a timely withdrawal in the Federal Register
informing the public that some or all of the amendments in the final
rule will not take effect.
Comments. Written comments must be received by April 23, 2008,
unless a public hearing is requested by April 3, 2008. If a hearing is
requested, written comments must be received by May 8, 2008.
Public Hearing. If anyone contacts EPA requesting to speak at a
public hearing concerning the proposed regulation by April 3, 2008, we
will hold a public hearing on April 8, 2008.
ADDRESSES: Comments. Submit your comments, identified under Docket ID
No. EPA-HQ-OAR-2006-0971 by one of the following methods:
www.regulations.gov. Follow the online instructions for
submitting comments.
E-mail: a-and-r-docket@epa.gov
Fax: (202)-566-9744
Mail: National Volatile Organic Compound Emission
Standards for Aerosol Coatings, Environmental Protection Agency, Mail
Code: 2822T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
Please include two copies.
Hand Delivery: EPA Docket Center, 1301 Constitution
Avenue, NW., EPA Headquarters Library, Room 3334, EPA West Building,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2006-
[[Page 15422]]
0971. The EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
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 www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
www.regulations.gov index. 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, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the National Volatile Organic
Compound Emission Standards for Aerosol Coatings, EPA/DC, EPA West
Building, EPA Headquarters Library, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the Air Docket is (202) 566-1742.
Public Hearing. If a public hearing is held, it will be held at 10
a.m. on April 8, 2008 at EPA's Campus located at 109 T.W. Alexander
Drive in Research Triangle Park, NC, or an alternate site nearby.
Persons interested in presenting oral testimony must contact Ms. Joan
Rogers at (919) 541-4487 no later than April 3, 2008. If you are
interested in attending the public hearing, contact Ms. Joan Rogers at
(919) 541-4487 to verify that a hearing will be held. If no one
contacts EPA requesting to speak at a public hearing concerning this
rule by April 3, 2008 this meeting will be cancelled without further
notice.
FOR FURTHER INFORMATION CONTACT: For further information, contact Ms.
J. Kaye Whitfield, U.S. EPA, Office of Air Quality Planning and
Standards, Sector Policies and Programs Division, Natural Resources and
Commerce Group (E143-03), Research Triangle Park, NC 27711; telephone
number (919) 541-2509; facsimile number (919) 541-3470; e-mail address:
whitfield.kaye@epa.gov. For information concerning the Clean Air Act
(CAA) section 183(e) consumer and commercial products program, contact
Mr. Bruce Moore, U.S. EPA, Office of Air Quality Planning and
Standards, Sector Policies and Programs Division, Natural Resources and
Commerce Group (E143-03), Research Triangle Park, North Carolina 27711,
telephone number: (919) 541-5460, facsimile number (919) 541-3470, e-
mail address: moore.bruce@epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Why Is EPA Using a Direct Final Rule?
II. Does This Action Apply to Me?
III. What Should I Consider as I Prepare My Comments for EPA?
IV. What Are the Amendments Made by This Direct Final Rule?
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. Why Is EPA Using a Direct Final Rule?
The EPA is publishing this rule without a prior proposed rule
because we view this as a non-controversial action and anticipate no
adverse comment. EPA has identified misstatements and possibly
confusing language in the preamble and regulatory text on how compounds
are added to the list in Tables 2A, 2B, or 2C of subpart E, 40 CFR part
59, and when distributors and retailers are regulated entities
responsible for compliance with the final rule. The amendments to the
Aerosol Coatings final rule described herein consist of clarifications
that do not make material changes to the rule.
However, in the ``Proposed Rules'' section of today's Federal
Register, we are publishing a separate document that will serve as the
proposed rule to the National Volatile Organic Compound Emission
Standards for Aerosol Coatings (40 CFR Part 59) if adverse comments are
received on this direct final rule. We will not institute a second
comment period on this action. Any parties interested in commenting
must do so at this time. If EPA receives adverse comment, we will
publish a timely withdrawal in the Federal Register informing the
public that some or all of the amendments in this direct final rule
will not take effect. We would address all public comments in any
subsequent final rule based on the proposed rule. For further
information about commenting on this rule, see the ADDRESSES section of
this document.
II. Does This Action Apply to Me?
The entities potentially affected by this direct final rule are the
same entities that are subject to the Aerosol Coatings final rule. The
entities affected by the Aerosol Coatings final rule include:
Manufacturers, processors, distributors, importers of aerosol coatings
for sale or distribution in the United States, and manufacturers,
processors, distributors, or importers who supply the entities listed
above with aerosol coatings for sale or distribution in interstate
commerce in the United States.
III. What Should I Consider as I Prepare My Comments for EPA?
A. Submitting CBI. Do not submit this information to EPA through
www.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
[[Page 15423]]
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.
B. Tips for Preparing Your Comments. When submitting comments,
remember to:
Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
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.
Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
Describe any assumptions and provide any technical
information and/or data that you used.
If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
Provide specific examples to illustrate your concerns, and
suggest alternatives.
Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
Make sure to submit your comments by the comment period
deadline identified.
IV. What Are the Amendments Made by This Direct Final Rule?
The direct final rule clarifies and amends certain explanatory and
regulatory text in the Aerosol Coatings final rule.
First, we are amending the explanatory text in section III.C. of
the preamble (entitled ``Consideration of Other Factors in the
Consideration of Best Available Controls''), which states that
compounds will be added to the list in Tables 2A, 2B, or 2C if they are
identified in an initial notification or update. This statement is
inconsistent with the regulatory text in Sec. 59.511(j), which
provides that compounds are to be added to the list in Tables 2A, 2B,
or 2C only through a petition to the Agency. Through today's action, we
are amending the preamble to the Aerosol Coatings final rule to track
the regulatory text that provides persons seeking to have a compound
added to Tables 2A, 2B, or 2C must follow the petition process
prescribed by 59.511(j).
Second, EPA has determined that certain language in the regulatory
text is inconsistent and potentially confusing as to when distributors
and retailers are regulated entities responsible for compliance with
the Aerosol Coatings final rule. First, the second phrase in the first
sentence of Sec. 59.501(a) suggests that a distributor is only
regulated by the final rule if it is named on the label, and the second
sentence in Sec. 59.501(a) states ``Distributors whose names do not
appear on the label for the product are not regulated entities.'' The
language in the first two sentences of Sec. 59.501(a) is inconsistent
and incomplete because, under Sec. 59.501(b)(2), distributors who
specify a formulation and distributors whose names appear on the label
for the product are responsible for compliance with the final rule. We
are adding language to Sec. 59.501(a) to make that section consistent
with Sec. 59.501(b)(2). Specifically, we are adding language to the
second phrase in the first sentence of Sec. 59.501(a) to include
distributors who specify a formulation, and deleting the entire second
sentence in Sec. 59.501(a).
Third, the third sentence in Sec. 59.501(a), which states
``Distributors include retailers whose names appear on the label for
the product,'' is potentially confusing because it fails to note that,
as defined in Sec. 59.503, retailers are distributors if they meet the
definition of ``distributor.'' A retailer who both meets the definition
of ``distributor'' in Sec. 59.503 and either is named on the label or
specifies the formulation of a product is responsible for compliance
with the final rule under Sec. 59.501(b)(2). To avoid any confusion
about when retailers are regulated by the final rule, we are deleting
the third sentence in 59.501(a) and replacing it with a sentence
stating ``Distributors include retailers who fall within the definition
of `distributor' in Sec. 59.503.''
Fourth, EPA has identified that several provisions in Sec.
59.501(b) use the phrase ``the regulated entity'' to identify when
certain entities are responsible for compliance with provisions of the
final rule. In some instances, however, the final rule provides that
different entities will be regulated entities responsible for
compliance with provisions of the final rule for a given product. To
avoid any confusion about whether there can be more than one regulated
entity for a given product, we are changing the phrase from ``the
regulated entity'' to ``a regulated entity.'' This change does not
change the compliance responsibilities for any entity.
Fifth, we identified that a few words were inadvertently omitted
from the regulatory text in Sec. 59.501(b)(2). The first sentence of
Sec. 59.501(b)(2) uses the phrase ``regulated entity responsible for
compliance,'' while the second sentence uses the phrase ``responsible
for compliance'' without the words ``regulated entity.'' To avoid any
confusion, we are adding the words ``a regulated entity'' to the second
sentence in Sec. 59.501(b)(2) to make clear that the distributor is a
regulated entity responsible for compliance with provisions of the
final rule if it either is named on the label or has specified
formulations to be used by a manufacturer.
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735 October 4, 1993) and
is therefore not subject to review under the EO.
B. Paperwork Reduction Act
This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b). This action does not impose any
new information collection burden because it serves to clarify certain
explanatory and regulatory text. No additional information collection
is necessary for this action.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of today's final rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule will not impose any
[[Page 15424]]
requirements on small entities. We have determined that small
businesses will not incur any adverse impacts because EPA is taking
this action to make certain clarifications and amendments to the
Aerosol Coatings final rule, and these clarifications and amendments do
not create any new requirements or burdens. No costs are associated
with these amendments.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
EPA has determined that this rule does not contain a Federal
mandate that may result in expenditures of $100 million or more for
State, local, and Tribal governments, in the aggregate, or the private
sector in any one year. Thus, this action is not subject to the
requirements of sections 202 and 205 of UMRA because EPA is taking this
action to make certain clarifications and amendments to the Aerosol
Coatings final rule, and these clarifications and amendments do not
create any new requirements or burdens.
EPA has determined that this rule contains no regulatory
requirements that might significantly or uniquely affect small
governments because they contain no regulatory requirements that apply
to such governments or impose obligations upon them.
E. Executive Order 13132: Federalism
Executive Order (EO) 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999), requires EPA to develop an accountable process to
ensure ``meaningful and timely input by State and local officials in
the development of regulatory policies that have federalism
implications.'' ``Policies that have federalism implications'' is
defined in the EO to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in EO 13132. The CAA establishes the relationship between
the Federal Government and the States, and this action does not impact
that relationship. The final rule requirements will not supersede State
regulations that are more stringent. Thus, EO 13132 does not apply to
this rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order (EO) 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), requires EPA to develop an accountable process to ensure
``meaningful and timely input by Tribal officials in the development of
regulatory policies that have Tribal implications.'' This final action
does not have Tribal implications as specified in EO 13175. The final
regulatory action does not have a substantial direct effect on one or
more Indian tribes, in that this action imposes no regulatory burdens
on Tribes. Furthermore, the action does not affect the relationship or
distribution of power and responsibilities between the Federal
Government and Indian tribes. The CAA and the Tribal Authority Rule
(TAR) establish the relationship of the Federal Government and Tribes
in implementing the CAA. Thus, EO 13175 does not apply to this rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order (EO) 13045 (62 FR 19885, April 23,
1997) as applying to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Order has the potential to influence the regulation. This action is
not subject to EO 13045 because it is based solely on technology
performance.
H. Executive Order 13211: Energy Effects
This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) of 1995 (Pub. L. 104-113, Section 12(d)), (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities, unless to do so would be inconsistent with
applicable law or otherwise impractical. The VCS are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
VCS bodies. The NTTAA directs EPA to provide Congress, through OMB,
explanations when the EPA does not use available and applicable VCS.
The rulemaking involves technical standards. Therefore, the Agency
conducted a search to identify potentially applicable voluntary
consensus standards. However, we identified no such standards, and none
were brought to our attention in comments. Therefore, EPA has decided
to use the following standards in the final rule: California Air
Resources Board Method 310--Determination of VOC in Consumer Products
and Reactive Organic Compounds in Aerosol Coating Products; EPA Method
311--Analysis of Hazardous Air Pollutant Compounds in Paints and
Coatings by Direct Injection into a Gas Chromatograph (40 CFR part 63,
appendix A), in conjunction with
[[Page 15425]]
American Society of Testing and Materials (ASTM) Method D3063-94 or
D3074-94 for analysis of the propellant portion of the coating; South
Coast Air Quality Management District (SCAQMD) Method 318-95,
Determination of Weight Percent Elemental Metal in Coatings by X-ray
Diffraction, July, 1996, for metal content; and ASTM D523-89
(Reapproved 1999), Standard Test Method for Specular Gloss for specular
gloss of flat and nonflat coatings.
EPA Method 311--Analysis of Hazardous Air Pollutant Compounds in
Paints and Coatings by Direct Injection into a Gas Chromatograph (40
CFR part 63, appendix A) also is a compilation of voluntary consensus
standards. The following are incorporated by reference in EPA Method
311--Analysis of Hazardous Air Pollutant Compounds in Paints and
Coatings by Direct Injection into a Gas Chromatograph (40 CFR part 63,
appendix A): ASTM D1979-91, ASTM D3432-89, ASTM D4457-85, ASTM D4747-
87, ASTM D4827-93, and ASTM PS9-94.
For the methods required by the final rule, a source may apply to
EPA for permission to use alternative test methods or alternative
monitoring requirements in place of any required testing methods,
performance specifications, or procedures under Sec. Sec. 63.7(f) and
63.8(f) of subpart A of the General Provisions.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income populations. Further, it establishes national emission standards
for VOC in aerosol coatings.
K. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing the final rule
amendment and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of this final rule amendment in the Federal
Register. The final rule amendment is not a ``major rule'' as defined
by 5 U.S.C. 804(2). This final rule is effective on June 23, 2008.
List of Subjects in 40 CFR Part 59
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: March 13, 2008.
Stephen L. Johnson,
Administrator.
0
For the reasons set out in the preamble, part 59 of Title 40 of the
Code of Federal Regulations is amended as follows:
PART 59--[AMENDED]
0
1. The authority citation for part 59 continues to read as follows:
Authority: 42 U.S.C. 7414 and 7511b(e).
Subpart E--[Amended]
0
2. Section 59.501 is amended by revising paragraphs (a) and (b)(1),
(b)(2) and (b)(3) to read as follows:
Sec. 59.501 Am I subject to this subpart?
(a) The regulated entities for an aerosol coating product are the
manufacturer or importer of an aerosol coating product and a
distributor of an aerosol coating product if it is named on the label
or if it specifies the formulation of the product. Distributors include
retailers who fall within the definition of ``distributor'' in Sec.
59.503.
(b) * * *
(1) If you are a manufacturer or importer, you are a regulated
entity responsible for ensuring that all aerosol coatings manufactured
or imported by you meet the PWR limits presented in Sec. 59.504, even
if your name is not on the label.
(2) If you are a distributor named on the label, you are a
regulated entity responsible for compliance with all sections of this
subpart except for the limits presented in Sec. 59.504. If you are a
distributor that has specified formulations to be used by a
manufacturer, then you are a regulated entity responsible for
compliance with all sections of this subpart.
(3) If there is no distributor named on the label, then the
manufacturer or importer is a regulated entity responsible for
compliance with all sections of this subpart.
* * * * *
[FR Doc. E8-5583 Filed 3-21-08; 8:45 am]
BILLING CODE 6560-50-P