Voluntary Labeling Program for Biobased Products, 38296-38317 [E9-17610]
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Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Proposed Rules
DEPARTMENT OF AGRICULTURE
7 CFR Part 2904
RIN 0503–AA35
Voluntary Labeling Program for
Biobased Products
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AGENCY: Departmental Administration,
USDA.
ACTION: Notice of proposed rulemaking.
SUMMARY: The U.S. Department of
Agriculture (USDA) is proposing to
establish a voluntary labeling program
for biobased products under section
9002 of the Farm Security and Rural
Investment Act of 2002, as amended by
the Food, Conservation, and Energy Act
of 2008. Under the proposed labeling
program, a biobased product, after being
certified by USDA, could be marketed
using the ‘‘USDA Certified Biobased
Product’’ label. The presence of the
label will mean that the product meets
USDA standards for the amount of
biobased content and that the
manufacturer or vendor has provided
relevant information on the product for
the USDA BioPreferred Web site. The
proposed rule applies to manufacturers
and vendors who wish to participate in
the voluntary labeling program. The
proposed rule also applies to other
entities (e.g., trade associations) that
wish to use the label to promote
biobased products.
DATES: USDA will accept public
comments on this proposed rule until
September 29, 2009.
ADDRESSES: You may submit comments
by any of the following methods. All
submissions received must include the
agency name and Regulatory
Information Number (RIN). The RIN for
this rulemaking is 0503–AA35. Also,
please identify submittals as pertaining
to the ‘‘Proposed Voluntary Labeling
Program.’’
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail/commercial/hand delivery:
Mail or deliver your comments to: Ron
Buckhalt, USDA, Office of the Assistant
Secretary for Administration, Room 342,
Reporters Building, 300 Seventh Street,
SW., Washington, DC 20024.
• Persons with disabilities who
require alternative means for
communication for regulatory
information (Braille, large print,
audiotape, etc.) should contact the
USDA TARGET Center at (202) 720–
2600 (voice) and (202) 690–0942 (TTY).
You may also send comments on the
information collection aspects of this
rule directly to the Office of Information
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and Regulatory Affairs of OMB,
Attention: Desk Officer for Agriculture,
Margaret Malanoski, 725 17th Street,
NW., Room 10202, Washington, DC
20503. Comments should reference
OMB control number 0503–NEW.
FOR FURTHER INFORMATION CONTACT: Ron
Buckhalt, USDA, Office of the Assistant
Secretary for Administration, Room 342,
Reporters Building, 300 Seventh Street,
SW., Washington, DC 20024; e-mail:
biopreferred@usda.gov; phone (202)
205–4008. Information regarding the
Federal Procurement Program of
Biobased Products (one part of the
BioPreferred Program) is available on
the Internet at https://
www.biopreferred.gov.
SUPPLEMENTARY INFORMATION: The
information presented in this preamble
is organized as follows:
I. Background
A. Authority
B. Overview of Section 9002
II. Purposes of the Voluntary Labeling
Program
III. Voluntary Labeling Program
A. Applicability
B. Criteria for Obtaining Certification
C. Initial Approval Process
D. Appeals
E. Information Posted on Web Site
F. Applications for Reformulated Products
G. Requirements Associated With the Label
H. Violations
I. Recordkeeping Requirements
J. Reporting
IV. Suggested Comment Topics
V. Regulatory Information
A. Executive Order 12866: Regulatory
Planning and Review
B. Regulatory Flexibility Act (RFA)
C. Executive Order 12630: Governmental
Actions and Interference With
Constitutionally Protected Property
Rights
D. Executive Order 13132: Federalism
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12372:
Intergovernmental Review of Federal
Programs
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
H. Paperwork Reduction Act
I. Government Paperwork Elimination Act
Compliance
J. Small Business Regulatory Enforcement
Fairness Act
I. Background
A. Authority
The voluntary labeling program for
biobased products is proposed under
the authority of section 9002 of the
Farm Security and Rural Investment Act
of 2002 (FSRIA)(referred to in this
preamble as ‘‘section 9002’’), as
amended by the Food, Conservation,
and Energy Act of 2008 (FCEA), 7 U.S.C.
8102.
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B. Overview of Section 9002
Section 9002 establishes a program for
the Federal procurement of biobased
products by Federal agencies and a
voluntary program for the labeling of
biobased products. These two programs,
which are referred to collectively by
USDA as the BioPreferredSM Program,
are briefly discussed below.
Federal Procurement of Biobased
Products. Section 9002 requires Federal
agencies to develop procurement
programs that give preference to the
purchase of biobased products (hereafter
referred to in this Federal Register
notice as the ‘‘preferred procurement
program’’). Federal agencies and their
contractors are required to purchase
biobased products, as defined in
regulations implementing the statute,
that are within designated items 1 when
the cumulative purchase price of the
procurement item(s) procured is more
than $10,000 or when the quantities of
functionally equivalent items purchased
over the preceding fiscal year equaled
$10,000 or more. Each Federal agency
and contractor must procure biobased
products at the highest content levels
within each designated item unless the
agency determines that the items are not
reasonably available, fail to meet
applicable performance standards, or
are available only at an unreasonable
price.
The final guidelines for the preferred
procurement program were published in
the Federal Register on January 11,
2005 (70 FR 1792). The guidelines are
contained in 7 CFR part 2902,
‘‘Guidelines for Designating Biobased
Products for Federal Procurement.’’
Part 2902 is divided into two
subparts, ‘‘Subpart A—General,’’ and
‘‘Subpart B—Designated Items.’’ Subpart
A addresses the purpose and scope of
the guidelines and their applicability,
provides guidance on product
availability and procurement, defines
terms used in part 2902, and addresses
affirmative procurement programs and
USDA funding for testing. Subpart B
identifies designated items and specifies
their minimum biobased contents, the
effective date of the procurement
preference for biobased products within
each designated item, and other
information (e.g., biodegradability).
USDA is responsible for designating
biobased items at the highest practicable
biobased content levels for the Federal
agencies’ preferred procurement
programs.
1 The term ‘‘designated item’’ refers to items
(generic groupings of specific products that perform
the same function) that have been afforded
preferred procurement by Federal agencies under
the BioPreferred Program.
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As part of the preferred procurement
program, section 9002 also requires
USDA to provide information to Federal
agencies on the availability, relative
price, performance, and environmental
and public health benefits of products
within such items and, as applicable
under section 9002(e)(1)(C), to
recommend the minimum level of
biobased content to be contained in the
products within a designated item.
To date, USDA has designated 33
items used in a variety of applications,
including cafeteria ware, personal and
institutional cleaning products,
construction products, and lubricants
and greases.
Voluntary Labeling Program. Section
9002 also requires USDA to establish a
voluntary labeling program under which
USDA authorizes manufacturers and
vendors of biobased products to use a
‘‘USDA Certified Biobased Product’’
label (hereafter referred to in this
preamble as ‘‘the label’’). The voluntary
labeling program is intended to
encourage the purchase and use of
biobased products by reaching beyond
the Federal purchasing community and
promoting the purchase of biobased
products by the general public. In
establishing this program, USDA must
identify the criteria to determine those
products on which the label may be
used and must develop specific
requirements for how the label can be
used. It is USDA’s intent that the
presence of the label on a product will
mean that the labeled product is one for
which credible factual information is
available as to the biobased content,
consistently measured across labeled
products by use of the ASTM
radioisotope test D6866.
In developing the proposed voluntary
labeling program, USDA held
discussions with other agencies that
have implemented labeling programs,
such as the ‘‘ENERGY STAR®’’ program
implemented by the U.S. Department of
Energy and the U.S. Environmental
Protection Agency (EPA). USDA has
also consulted with representatives of
the Department of Agriculture’s
National Organic program and others of
the Agricultural Marketing Service.
Further, USDA consulted the Federal
Trade Commission, which issues the
‘‘Guides for the Use of Environmental
Marketing Claims’’ to ensure that the
provisions of the proposed voluntary
labeling program were consistent with
the Guides. USDA also held a public
meeting on July 22, 2008, to seek input
on the content and use of the label from
the public and industry stakeholders.
The following section of the preamble
presents the goal of the voluntary
labeling program and the objectives
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toward achieving that goal. That section
is followed by a summary of the
voluntary labeling program that USDA
is proposing to implement under section
9002(h).
II. Goal of the Voluntary Labeling
Program
USDA’s goal in proposing this
voluntary labeling program is to
encourage the increased use of biobased
products in all market sectors. To
achieve this goal, USDA has identified
the following objectives:
Promotion of biobased products. The
voluntary labeling program is intended
to promote and increase the use of
biobased products. In general, the
labeling program supports this goal by
recognizing manufacturers and vendors
that produce and market products that
utilize biobased materials and by
encouraging consumers to purchase
such products.
Whereas the preferred procurement
program is specific to Federal agencies,
the voluntary labeling program is
intended to encompass all individuals
and organizations making purchasing
decisions. We are proposing that there
be two slightly different versions of the
label, one for those biobased products
that have been designated for Federal
preferred procurement because they are
within a designated item, and another
for those products that are not within a
designated item. The label artwork for
products within designated items would
include the letters ‘‘FP’’ to indicate that
they are Federally preferred. USDA
believes that informing consumers that
these products have been designated for
Federal preferred procurement will be
beneficial. As part of the process of
designating items for preferred
procurement, USDA gathers and
evaluates information regarding the
biobased product’s life cycle costs and
environmental performance as well as
functional performance. Thus, the ‘‘FP’’
on the label will inform consumers that
USDA has evaluated representative
products within the designated item and
found them to be qualified for the
Federal preferred procurement program.
USDA also notes that the identification
of products that have been designated
for preferred procurement would also be
accomplished by listing those products
on the USDA Web site and in Federal
procurement catalogues.
Furthermore, the voluntary labeling
program will increase the amount of
information available to manufacturers
whose products may utilize biobased
materials or products as a component of
their finished products or as part of
their manufacturing process. USDA
expects that this increased information
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will encourage these manufacturers to
consider using and/or increasing the
amount of biobased materials when
designing or manufacturing their
products, thereby further increasing the
purchase of biobased materials. For
example, manufacturers of equipment
that uses hydraulic fluids are
encouraged to consider the use of
biobased hydraulic fluids if available
information indicates that the
performance of these fluids meets or
exceeds their requirements.
Increase public awareness of biobased
products. The voluntary labeling
program will raise the visibility of
biobased products within the Federal
government and within the commercial
marketplace. The labeling program will
also provide a unique and identifiable
designator recognized in the U.S. and
foreign markets.
To the extent that the voluntary
labeling program achieves these
objectives, there may be an increased
purchase of biobased products, which is
then expected to reduce petroleum
consumption, increase the use of
renewable resources, better manage the
carbon cycle, and, may contribute to
reducing adverse environmental and
health impacts. The program is also
expected to promote economic
development for biobased product
manufacturers and vendors by creating
new jobs and providing new markets for
farm commodities.
III. Voluntary Labeling Program
In developing the voluntary labeling
program, USDA has one primary goal—
to encourage the purchase of biobased
products. In implementing this goal,
USDA aims to ensure that only biobased
products that meet the criteria set forth
in the voluntary labeling program are
labeled with the ‘‘USDA Certified
Biobased Product’’ label and that the
label is used properly. USDA believes
that products carrying the label will
become readily recognizable as biobased
products, distinct from those that do not
carry the label. Further, as the label will
have the percent of biobased material
printed on it, consumers will recognize
that products carrying the label meet
certain criteria that set them apart from
other products.
A. Applicability
The proposed rule would apply to
manufacturers and vendors of biobased
products, as well as to other entities
(e.g., trade associations, public interest
groups) that promote, sell, or use the
products. USDA believes that each of
these groups must comply with the
labeling requirements in order to ensure
that only certified biobased products
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(i.e., biobased products that have been
approved for use of the label under this
program) carry the label and that the
label is used correctly. USDA believes
that the goals of the voluntary labeling
program can be achieved, and the
beneficial impacts of the BioPreferred
program can be increased, if
manufacturers, vendors, and other
entities are allowed to market and
promote the manufacturers’ biobased
products with a credible biobased
products labeling program.
Once USDA has approved a biobased
product for labeling by its manufacturer
or vendor, an equally important aspect
in ensuring the integrity of the labeling
program is the proper use of the label.
Label misuse can occur at the
manufacturer level (e.g., affixing the
label to a non-certified biobased
product) and at the retail level (e.g.,
using the label to imply that a noncertified biobased product has been
certified), or by other entities wishing to
use the label in promoting the sales or
public awareness of non-certified
biobased products (e.g., on a Web site or
in promotional materials).
While the labeling of biobased
products is voluntary, manufacturers,
vendors, and other entities wishing to
use the label in their marketing,
promotional, or educational efforts
would be required to comply with
regulatory requirements as proposed
herein. USDA believes these
requirements for use of the label are
necessary to avoid misleading
consumers regarding whether a product
has been certified by USDA under the
voluntary labeling program.
B. Criteria for Obtaining Certification
To be eligible for USDA certification
to use the label, USDA proposes that a
product meet two criteria, as discussed
below.
Criterion 1: Biobased Product. The
product must be a biobased product.
Biobased product is defined in section
2904.2 of today’s proposed rule as
follows: ‘‘The term ‘biobased product’
means a product determined by the
Secretary to be a commercial or
industrial product (other than food or
feed) that is—(A) composed, in whole or
in significant part, of biological
products, including renewable domestic
agricultural materials and forestry
materials; or (B) an intermediate
ingredient or feedstock. For the
purposes of this subpart, the term
‘biobased product’ does not include
motor vehicle fuels, heating oil,
electricity produced from biomass, or
any mature market products. Products
from a mature market will be
determined on a case-by-case basis.’’
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Rationale for Criterion 1: As
discussed earlier, section 9002 requires
USDA to establish a voluntary labeling
program under which USDA authorizes
manufacturers and vendors of biobased
products to use a ‘‘USDA Certified
Biobased Product’’ label. USDA is
proposing that mature market products
not be eligible to use the label except on
a case-by-case basis. Mature market
products are those biobased products
that had significant national market
penetration in 1972. Examples of mature
market products include cotton shirts or
towels, paper plates, and wood
furniture. USDA has excluded mature
market products from the Federal
preferred procurement program. In
USDA’s explanation for excluding
mature market products from the
preferred procurement program, USDA
stated in the preamble to the final
Guidelines (70 FR 1802), ‘‘The intent of
section 9002, as described in the
conference report accompanying FSRIA,
‘is to stimulate the production of new
biobased products and to energize
emerging markets for those products.’ ’’
Based on conference report, it is clear
that Congress did not intend for mature
market products to be given Federal
procurement preference. It is not clear,
however, whether this exclusion of
mature market products was intended to
apply to the voluntary labeling program.
The procurement preference program
and the labeling program are contained
in different paragraphs of the statute,
and the conference report does not
specifically state whether the language
quoted above refers to just one or to
both paragraphs.
USDA believes, however, that the
widespread labeling of mature market
products could negatively impact the
entry of new biobased products into
market segments in which mature
products already have significant
market shares. Thus, USDA believes
that it is reasonable to exclude many
mature market products from the
labeling program, as it has done for the
preferred procurement program. USDA
is, however, proposing to allow
manufacturers of mature market
products to appeal (on a case-by-case
basis) the exclusion of their products
from the program.
Criterion 2: Minimum Biobased
Content. For a biobased product to
receive certification under this proposed
rule, the biobased content of that
product must be at or above its
applicable minimum biobased content,
as described below. USDA believes this
requirement is necessary so that the
label is not used to promote products
with de minimis biobased content. As
discussed below, the applicable
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minimum biobased content depends
under which of the three proposed
categories the product falls.
1. Biobased products within one or
more designated items. If a biobased
product (including an intermediate
ingredient or feedstock) is within a
designated item at the time of
submitting an application for
certification, the applicable minimum
biobased content for use of the label
would be the minimum biobased
content specified for that item in 7 CFR
2902. As discussed in more detail
below, once an item has been
designated, its minimum biobased
content, as specified in 7 CFR part 2902,
becomes the applicable minimum
biobased content for all products within
that designated item, regardless of any
previous minimum biobased content
used to qualify a product for using the
label.
If a biobased product is marketed
within more than one designated item,
and uses the same packaging, its
biobased content must meet or exceed
the specified minimum biobased
content for each of the designated items
in order to use the label for each item.
For example, Product A is currently
marketed as a ‘‘glass cleaner’’ and a
‘‘bath and tile cleaner’’ and uses the
same packaging in both markets. USDA
has designated both these categories of
products as items under its BioPreferred
procurement program. Product A has a
biobased content of 60 percent. The
minimum biobased content of
designated item ‘‘glass cleaners’’ is 49
percent and the minimum biobased
content of designated item ‘‘bath and
tile cleaners’’ is 74 percent. The
manufacturer would not be eligible to
apply for use of the label for Product A
under either designated item. If the
biobased content of Product A were
instead 80 percent, the manufacturer
would be eligible to use the label under
both designated items.
If, on the other hand, the
manufacturer packaged the product in
different packaging for marketing within
the two designated items (e.g., a blue
bottle for the glass cleaner and a green
bottle for the bath and tile cleaner), the
product marketed as a glass cleaner
would be eligible to apply to use the
label while the product marketed as
bath and tile cleaner would not be
eligible.
2. Finished biobased products that are
not within designated items. If a
biobased product is not within a
designated item at the time the
application for certification is
submitted, the applicable minimum
biobased content for the product for
using the label would be 51 percent,
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unless USDA approves an alternative
applicable minimum biobased content.
The proposed rule would allow
manufacturers, vendors, and trade
associations (individually or
collectively) who believe that the 51
percent minimum biobased content is
not appropriate for the biobased product
to conduct an analysis, as discussed
under ‘‘Alternative Minimum Biobased
Content Analysis’’ later in this
preamble, to support an alternative
applicable minimum biobased content.
If USDA approves the alternative
applicable minimum biobased content,
then that content becomes the
applicable minimum biobased content
for that product.
USDA recognizes that there will be
groups of biobased products that will be
certified to use the label that will never
be designated for preferred
procurement, primarily because these
products are produced by only one
manufacturer and, thus, there is not
sufficient market competition to justify
preferred procurement or they are not
used prevalently in the Federal
marketplace. However, USDA expects
that the majority of the biobased
products certified to use the label will
be within a group of products that
USDA designates for preferred
procurement. In those cases where
USDA subsequently designates an item
under which the certified biobased
product falls for inclusion in the
preferred procurement program, the
applicable minimum biobased content
for the product will then become the
minimum biobased content established
for the designated item under which the
product falls. As of the effective date of
the designation, only those products
that meet the new minimum biobased
content may continue to use the label.
3. Products that are intermediate
ingredients or feedstocks that are not
within designated items. If a biobased
product is an intermediate ingredient or
feedstock and is not within a designated
item at the time the application for
certification is submitted, the applicable
minimum biobased content for the
product for using the label would be 51
percent, unless USDA approves an
alternative applicable minimum
biobased content. As with the previous
product category, the proposed rule
would allow manufacturers, vendors,
and trade associations (individually or
collectively) who believe that the 51
percent minimum biobased content is
not appropriate to conduct an analysis,
as discussed under ‘‘Alternative
Minimum Biobased Content Analysis’’
later in this preamble, to support an
alternative applicable minimum
biobased content. If USDA approves the
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alternative applicable minimum
biobased content, then that content
becomes the applicable minimum
biobased content for that product.
Rationale for Criterion 2: USDA
believes setting the applicable minimum
biobased content of products within
designated items at the minimum
biobased content specified under the
preferred procurement program is
appropriate, as USDA has had an
opportunity to perform an analysis on
these products, including identifying
similar biobased products and their
manufacturers, and obtaining biobased
contents for similar biobased products.
USDA intends to proceed with the
designation of numerous items for
which it has, or is currently gathering,
information. Once the designation
process has been completed for those
items that have been identified for
designation, USDA intends to revisit, on
a periodic basis, the minimum biobased
content that was established for
designated items at the time of their
designation. As scientific advances and
economic conditions warrant, USDA
would expect that the applicable
minimum biobased content for
designated items will rise as
competitors apply advances and
increase the biobased content of
designated products. Thus, it is USDA’s
expectation that the applicable
minimum biobased content of
designated items will increase as
advancements are made in biobased
product technology. USDA also notes
that proposed revisions to the
applicable minimum biobased content
for designated items will be announced
in the Federal Register and the public
will have an opportunity to provide
comments on the proposal.
For the second and third categories of
products (finished biobased products
and intermediate ingredients and
feedstocks that are not within
designated items) USDA considered
several options for setting the minimum
biobased content, including the use of
the lowest minimum biobased content
for any item designated to date. USDA
decided, however, that in the absence of
the level of detailed product
information for setting a minimum
biobased content based on productspecific data (as is used under the
preferred procurement program), and in
an effort to discourage minimal use of
biobased feedstocks in what are
otherwise not biobased products, it is
reasonable to consider such finished
products as ‘‘biobased’’ if they contain
a significant amount of biobased
materials; that is, at least 51 percent of
the product is biobased. Thus, USDA is
proposing that all finished products that
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are not within designated items and all
intermediate ingredients and feedstocks
that are not within designated items
must contain at least 51 percent
biobased content to be qualified for the
label.
USDA recognizes, however, that for
some finished products (and
intermediate ingredients) a 51 percent
minimum biobased content may result
in a product that is not viable. USDA
also recognizes that the 51 percent
minimum biobased content could
discourage the development of new
biobased products or the continued
development of existing biobased
products. With this in mind, USDA will
continue to gather product-specific data
under the preferred procurement
program to determine applicable
minimum biobased contents.
Additionally, USDA believes that it is
reasonable to provide a procedure to
allow manufacturers, vendors, and trade
associations to propose an alternative
applicable minimum biobased content
for such products.
Alternative Minimum Biobased Content
Analysis
As noted above, manufacturers,
vendors, and trade associations would
be allowed to propose an alternative
minimum biobased content for products
not within a designated item if they
believe that the proposed minimum
biobased content is not appropriate for
their product(s). For USDA to consider
an alternative minimum biobased
content for these types of products,
manufacturers, vendors, and trade
associations would be required to
develop an analysis, in consultation
with USDA, that demonstrates the need
for an alternative applicable minimum
biobased content. USDA believes that
manufacturers, vendors, and trade
associations should consult with the
Department in developing the analysis
to help ensure that an appropriate
analysis is conducted.
While the analysis of the data
supporting a specific request for an
alternative minimum biobased content
will be performed on a case-by-case
basis, USDA anticipates that the
evaluation process will be standardized
and will be similar to the process used
to set minimum biobased contents
under the preferred procurement
program. Such a process would include
identifying similar biobased products
and their manufacturers and
determining biobased contents for
similar biobased products. USDA
recognizes the difficulties involved in
collecting biobased contents, due in
large part to the unpredictability of
manufacturer and vendor participation
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in providing products for testing.
Similar to the process used in the
preferred procurement program, the
establishment of alternative minimum
contents for the labeling program will
require a measure of flexibility to
address the variability in product type
and level of industry development. In
general, the number of samples that
should be obtained for the biobased
content analysis would depend on the
number of manufacturers of a product
and similar products available. USDA
would expect applicants to coordinate
with program officials to identify and
agree upon a reasonable number of
samples for the analysis. Emphasis
would be focused on obtaining the
maximum number of samples possible
without restricting the analysis process.
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C. Initial Approval Process
Application
Manufacturers and vendors seeking
use of the label on a qualified biobased
product must submit to USDA a
separate USDA-approved application for
certification for each product for which
the manufacturer or vendor wishes to
receive USDA approval to use the label.
Both the application and instructions
for submittal of the application will be
available on the USDA BioPreferred
Web site.
Each application must contain both
contact and product information.
Contact information would include the
applicant’s name, mailing address,
e-mail address, and telephone number,
and the name, mailing address,
telephone number, and e-mail address
(if available) of the person who prepared
the application.
Product information would include
the brand names or other product
identifying information (such as model
name or number, or UPC number) for
the product, the biobased content of the
product for which certification is
sought, contact information on the
third-party testing entity that tested the
biobased content and documentation
that the testing entity is ISO 9001
conformant, the product category under
which the product falls, and the
intended uses of the product. If the
product falls within a designated
item(s), the applicant would also
identify the name of the designated
item(s).
Lastly, the applicant would be
required to sign a statement that
certifies that the product identified in
the application is a biobased product as
defined in the labeling program and
commits the applicant to provide to
USDA, and to keep up-to-date, the
product’s brand name(s), or other
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identifying information; contact
information, including the name,
mailing address, e-mail address, and
telephone number of the applicant; the
biobased content of the product; and a
hot link directly to the applicant’s Web
site (if available). USDA is also
requiring that if manufacturers make
claims on the product packaging about
the environmental and human health
effects, life-cycle costs, sustainability
benefits, and performance of their
products that documentation supporting
such claims be maintained.
Justification for Required Information
USDA considers the information
required for the initial approval process
to be the minimum that will be needed
by USDA to confirm that products meet
the criteria for certification. The
following paragraphs summarize the
rationale for requiring the information
specified.
Contact Information. This information
is necessary for communicating with the
applicant concerning any issues with
the application, whether the application
is deficient, and whether the application
has been approved.
Brand Names. Because a
manufacturer or vendor may market the
same product under different brand
names (or other product identifiers such
as model names or numbers), the
application requires that all brand
names or other applicable product
identifiers for that product be provided.
This will prevent the necessity of
multiple applications from the same
manufacturer or vendor for the same
product.
Biobased Content Information. For
products in the three categories
discussed earlier, the biobased content
of the product for which certification is
sought would be determined by ISO
9001 certified or conformant,2 thirdparty testing firms using ASTM Method
D6866, ‘‘Standard Test Methods for
Determining the Biobased Content of
Natural Range Materials Using
Radiocarbon and Isotope Ratio Mass
Spectrometry Analysis.’’
In the case of a product that is
marketed under different brand names,
the proposed rule would allow the
manufacturer or vendor to test the
product once rather than requiring
brand-name specific data, thereby
minimizing unnecessary testing of the
same product that is simply marketed
under different brand names.
The applicant is required to provide
the product’s biobased content, as
2 ISO 9001 conformant means that the entity
meets the requirements of ISO 9001, but is not
required to be ISO 9001 certified.
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determined using ASTM Method D6866,
and contact information on the entity
that performed the testing. The
applicant is also required to provide
documentation that the third-party
testing entity that determined the
biobased content reported for the
product is ISO 9001 conformant. This
information is necessary to demonstrate
that the product’s biobased content
meets or exceeds the applicable
minimum biobased content and that a
qualified, independent, third-party
testing entity conducted the testing.
Product Category. The applicant is
required to identify whether the product
(1) falls within one or more designated
items under the preferred procurement
program (and if so, the applicant is
required to identify the item(s)), (2) is a
finished biobased product that is not
within a designated item, or (3) is an
intermediate ingredient or feedstock
that is not within a designated item.
This information is necessary to identify
the applicable minimum biobased
content and then to ensure that the
biobased content of the product meets
or exceeds the applicable minimum
biobased content.
Intended use(s). The applicant is
required to provide a description of the
intended uses of the product (e.g., as a
glass cleaner or as a penetrating
lubricant). USDA will use this
description to confirm that the product
is assigned to the appropriate
designated item(s), if applicable. This
will also allow USDA to determine if a
product should have been assigned to a
designated item, if the application
incorrectly indicates that the product
falls outside the designated item
category.
Certifications and statements. The
applicant must certify that the product
for which certification is sought is a
biobased product, as defined by the
labeling program. USDA is proposing
that applicants certify to this criterion
and keep appropriate records to
demonstrate that the product complies
with this certifying statement, which
USDA can then review during an audit.
This condition must be met in order to
ensure compliance with statutory
requirements under which the voluntary
labeling program is being established.
As noted earlier in this preamble, the
applicant is also required to commit to
providing to USDA information, and
keeping it up-to-date, for posting by
USDA on the BioPreferred Web site.
This information includes the product’s
brand name(s) or other product
identifiers; contact information,
including the name, mailing address, email address, and telephone number of
the applicant; biobased content; and a
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hot link directly to the applicant’s Web
site (if available).
While USDA is not requiring
manufacturers to analyze the
environmental and human health
effects, life-cycle costs, sustainability
benefits, and performance of their
products, manufacturers making claims
regarding these attributes of their
products must maintain documentation
to substantiate those claims pursuant to
the Federal Trade Commission (FTC)
Act. Section 5 of the FTC Act (15 U.S.C.
45) makes unlawful deceptive acts and
practices in or affecting commerce. The
FTC ‘‘Guides for the Use of
Environmental Marketing Claims’’ (16
CFR part 260) state that ‘‘any party
making an express or implied claim that
presents an objective assertion about the
environmental attribute of a product,
package or service must, at the time the
claim is made, possess and rely upon a
reasonable basis substantiating the
claim.’’
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
Evaluation
USDA will evaluate each application
to determine if it is a ‘‘complete’’
application (i.e., that it contains all of
the required information). If USDA
determines that the application is not
complete, it will return the application
to the applicant and provide an
explanation of the deficiencies in the
application. Once the deficiencies have
been addressed, the applicant may
resubmit the application for review by
USDA.
USDA will evaluate each complete
application to determine if the product
meets the criteria for certification
discussed above (and specified in
§ 2904.4). There will be no specified
deadline for application submissions;
applications will be worked on in a first
come first serve basis. Based on this
evaluation, USDA either will
conditionally approve the application or
will disapprove the application. USDA
will provide to each applicant a written
response within 60 days after the receipt
of a complete application, informing the
applicant whether or not its application
has been conditionally approved or has
been disapproved. An applicant who
receives notice from USDA that its
application has been conditionally
approved may not begin using the label
on its product until the applicant
receives a notice of certification from
USDA (see next paragraph). For those
applications that are not approved,
USDA will notify the applicant and
identify each criterion not met.
Applicants whose applications are not
approved have the right to appeal under
the proposed program first to USDA’s
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BioPreferred program office and then to
USDA policy officials.
Notice of Product Certification
After an applicant receives notice
from USDA that its application (for the
product to bear the label) has been
conditionally approved, the applicant
must provide certain information, as
discussed in Section E in this preamble,
to USDA. Once USDA has confirmed
that the information supplied by the
applicant is complete, USDA will
approve the product label application
and will issue a notice of product
certification to the applicant. USDA will
include in the notice of certification
information necessary for the applicant
to access the applicable label artwork
from the USDA BioPreferred Web site.
Upon receipt of the notice of
certification, the applicant may begin
using the label on the certified biobased
product.
Term of Product Certification
The effective (beginning) date of the
product certification is the date that the
applicant receives the notice of
certification from USDA. The
certification will remain valid for as
long as the biobased product is
manufactured in accordance with the
information supplied in the approved
application and presented on the USDA
Web site, with one exception. As
discussed earlier, it is USDA’s intent
that the applicable minimum biobased
content of designated items will
increase over time as advancements are
made in biobased product technology. If
the applicable required minimum
biobased content for a product to be
eligible to display the label is revised by
USDA, manufacturers and vendors may
continue to label their previously
certified product only if it meets the
new minimum biobased content level.
In those cases where the biobased
content of a certified product fails to
meet the new minimum biobased
content level, USDA will notify the
manufacturer or vendor that their
certification is no longer valid. Such
manufacturers and vendors must
increase the biobased content of their
product to a level at or above the new
minimum biobased content level and
must re-apply for certification within 60
days of receiving USDA’s notice if they
wish to continue to use the label.
Manufacturers and vendors who have
re-applied for certification may continue
using the existing label until they
receive notification from USDA on the
results of their re-application for
certification.
USDA considered proposing a
certification period of either three or
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five years, but decided that a fixed
certification period was unnecessary
and that the process of reapplying every
three or five years would impose an
undue burden on manufacturers who
did not reformulate their products. In
the case of items that become
designated, it is likely that the required
minimum biobased content for the item
could be different from the 51 percent
level used to qualify the item before it
was designated. USDA believes that, in
those cases, only those products that
meet the new minimum biobased
content should be eligible to display the
label. Thus, USDA is proposing that if
a certified product’s biobased content is
below the newly established minimum
biobased content, the manufacturer
must discontinue applying the label as
of the effective date of the item
designation. The same would be true in
any other case where USDA, through
established notice and comment
rulemaking procedures, revises the
minimum biobased content applicable
to a previously certified product.
USDA points out that affixing the
label to a certified biobased product
does not imply that the useful life or the
shelf life of the product has been
affected in any way. Purchasers of
labeled certified biobased products,
therefore, should continue to look to
information from the manufacturer or
vendor to ascertain whether a product
will perform as advertised at the time
the purchase is made.
D. Appeals
Today’s proposed rule includes
provisions for appeal by an applicant
whose application for certification is
denied by USDA. In addition, entities
that have been cited for a violation or
that have received a notice of
suspension or a notice of revocation
may also file an appeal. All appeals
must be filed within 30 days of receipt
of the applicable notice. Appeals must
be made in writing to the Program
Manager of the Voluntary Labeling
Program for Biobased Products and
must contain, in part, a statement,
including appropriate substantiating
documentation, of the appellant’s
reasons for believing that USDA
wrongfully denied the application or
issued a notice of violation, suspension,
or revocation. If the appellant is
dissatisfied with the results of this
appeal, he/she may raise the appeal to
the Assistant Secretary for
Administration by letter request.
Appeals to the Assistant Secretary for
Administration must be filed within 30
days of receipt of the notice of decision
from the appeal to the Program
Manager.
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The proposed rule also includes
provisions for manufacturers or vendors
of mature market products to appeal the
exclusion of their products from the
voluntary labeling program if they
believe that conditions justify the use of
the label on their products.
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
E. Information Posted on Web Site
Before USDA issues the notice of
certification to a manufacturer or vendor
to use the label on a biobased product,
the manufacturer or vendor must submit
contact and product information to
USDA, which USDA will then post on
the USDA BioPreferred Web site (which
can be accessed at https://
www.biopreferred.gov). This
information must be complete and must
be provided to USDA before USDA will
provide to the manufacturer or vendor,
the notice of certification and the
information for accessing the label
artwork. The information that must be
provided to USDA is:
• Product brand name(s) or other
identifying information;
• Contact information for the
applicant;
• Biobased content level; and
• A hot link directly to the
applicant’s Web site (if available).
In addition to the information listed
above, USDA encourages manufacturers
to provide other information related to
product features and applicability for
posting to the Web site.
USDA believes that making the
information identified above available
on the USDA BioPreferred Web site will
be an extremely valuable step in
establishing a database of certified
biobased products. Ideally, both Federal
agencies and public consumers will be
able to readily access information that
will help them in their decision-making
regarding the purchase of biobased
products. USDA believes that making
this information available not only to
Federal agencies, but also to public
consumers will result in increased
consumer awareness of and use of
biobased products. USDA is also
proposing that manufacturers of
certified biobased products must
include the USDA Web site address on
or in close proximity to the label.
Manufacturers must provide to USDA
updated information for posting by
USDA to the USDA BioPreferred Web
site whenever any of the information on
the Web site becomes outdated or if
additional relevant information becomes
applicable. As discussed in Section I of
this preamble, failure to provide USDA
with updated information will be
considered a violation of the
requirements of the labeling program.
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F. Applications for Reformulated
Products
A manufacturer may decide to change
the formulation of a certified biobased
product for various reasons including
performance issues, raw material
availability, or changes in production
processes. As discussed earlier,
manufacturers may also be required to
reformulate products that are within
designated items in response to USDA
re-evaluating and increasing the
applicable minimum biobased content
for products within the designated item.
For such reformulated products to be
eligible for USDA certification to use the
label, USDA proposes that a new
application be submitted to USDA, as
discussed below.
If a certified product’s biobased
content is decreased by any amount, a
new application would be required. In
any case where the biobased content of
a product is decreased from the original
formulation, the biobased content of the
reformulated product must still be at or
above the applicable minimum biobased
content for the product in order for the
product to qualify for the label.
In the case of a product whose
biobased content is reduced, the
manufacturer or vendor cannot affix the
label to the reformulated product until
they have submitted a new application,
provided USDA with the required
information on the reformulated
product for posting to the USDA
BioPreferred Web site, and received the
notice of certification for the
reformulated product from USDA. If the
manufacturer or vendor also continues
to sell the product in its original
formulation, the manufacturer or vendor
may continue to affix the label to the
original product.
If a certified product’s biobased
content is increased, and the
manufacturer wishes to change the label
to report the higher value, a new
application would be required. The
manufacturer or vendor may continue to
affix the label to the reformulated
product. However, the manufacturer or
vendor may not revise the biobased
content displayed on the label until they
have submitted a new application,
provided USDA with the required
information on the reformulated
product for posting to the USDA
BioPreferred Web site, and received the
notice of certification for the
reformulated product from USDA.
G. Requirements Associated With the
Label
Today’s proposed rule establishes
specific requirements for the use of the
label. The requirements in today’s
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proposed rule specify who may use the
label, correct and incorrect uses of the
label, the physical appearance of the
label, and restrictions on the use of the
label. These requirements are
summarized in the remainder of this
section.
USDA is also developing a Marketing
Guide that will be made available to
manufacturers and vendors of labeled
products. The purpose of this Marketing
Guide is to provide expanded
discussions of, and guidance on
resolving, implementation issues that
may arise related to the use of the label.
For example, USDA anticipates that
there will be questions related to the
best way to apply the label on very
small products, such as those within the
designated item ‘‘lip care products.’’
USDA believes that a Marketing Guide,
that can be updated frequently, is the
most efficient way to keep label users
informed of guidance provided by
USDA in response to implementation
issues that arise.
Who May Use the Label?
Any manufacturer or vendor who has
received notice of certification from
USDA, and any designated
representative of such manufacturers
and vendors, may use the label on the
product and its associated packaging
and in the advertising of the certified
biobased product. As proposed, only the
manufacturer or vendor (and their
designated representatives) of a certified
biobased product would be granted the
authority to affix the label to the
product. The process of applying for
and receiving certification requires
specific knowledge of the product and
its characteristics and formulation.
Obtaining certification also imposes the
requirement on the manufacturer and
vendor to provide certain information to
USDA, which USDA will then post on
the USDA BioPreferred Web site.
Other entities may use the label to
advertise or promote certified biobased
products (e.g., in catalogs or
procurement databases), as long as the
manufacturer or vendor of the product
(or one of their designated
representatives) has affixed the label to
the product or its packaging. USDA
believes that allowing other entities to
use the label in informational,
promotional, and educational materials
for certified biobased products will
promote the goal of encouraging the use
of biobased products.
Use of the Label
The label may be affixed only to
products (or associated packaging) for
which a manufacturer or vendor has
received a notice of certification under
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this part. USDA’s intent is for the label
to be used by manufacturers, vendors,
and other entities to distinguish
biobased products that meet or exceed
the criteria established by USDA from
those that do not meet the criteria. It is
also important that the label be used in
a consistent manner such that the label
and its meaning will become
recognizable in the marketplace. Use of
the label on non-certified products or
alterations in the appearance of the label
may confuse consumers and diminish
the value of not only the label, but also
the entire biobased product program.
Therefore, USDA has identified correct
and incorrect uses of the label, which
are discussed in the following
paragraphs.
Correct Uses. Proposed section 2904.7
identifies correct usages of the label.
These include, but are not limited to the
following:
• The label may be used in
advertisements, catalogs, procurement
databases, Web sites, and promotional
and educational materials;
• The label may appear next to a
picture of the product(s) or text
describing the product(s); and
• The label may be used without
reference to a specific certified biobased
product only when informing the public
about the purpose of the label. For
example, the following or similar claim
is acceptable: ‘‘Look for the ‘USDA
Certified Biobased Product’ label. It
means the product meets USDA
standards for the amount of biobased
content and the manufacturer or vendor
has provided relevant information on
the product for the USDA BioPreferred
Web site.’’ This exception allows
manufacturers, vendors, and other
entities to use the label in documents
such as corporate reports, but only in an
informative manner, not as a statement
of product certification.
Incorrect Uses. Proposed § 2904.7 also
identifies incorrect usages of the label.
These include, but are not limited to the
following:
• The label may not be used on noncertified products or in advertisements
or informational materials for noncertified products;
• The label may not be used to imply
endorsement by USDA or the
BioPreferred Program of any particular
product, service, or company; and
• The label may not be used in any
form that could be misleading to the
consumer, or on business cards,
company letterhead, or company
stationery.
Imported Products
Because other countries may have
different definitions of ‘‘biobased’’
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and/or use other terms, it is necessary
to address the use of the label on
products for import. The ‘‘USDA
Certified Biobased Product’’ label
signifies that a product meets specific
USDA criteria for biobased products.
Therefore, in order for products
imported for sale in the U.S. to carry the
label, they must meet the same criteria
as U.S.-sourced biobased products, and
their manufacturers and vendors must
apply for certification to use the label,
even if the products are considered
biobased products in the country in
which they are manufactured.
Contents of the Label
The label must consist of the
following:
• The logo with the phrase ‘‘USDA
Certified Biobased Product’’ and, where
applicable, the letters ‘‘FP’’ to indicate
that the product is within a Federally
preferred designated item (this label
content is collectively referred to as the
‘‘label artwork’’); and
• A statement that identifies the
biobased content of the product, as
reported in the approved application for
the product at the time the label is
affixed to the product or its packaging,
and whether the label applies to the
product or packaging.
USDA is proposing that the statement
that identifies the biobased content also
indicate whether the label applies to the
product or the packaging (e.g., Product:
57% biobased; Packaging: 90%
biobased). The USDA is proposing that
this statement be included in the label
in order to make it clear as to what the
certified biobased product is. USDA
believes that there will be instances
where the placement of the label on a
product or its packaging will not clearly
identify the certified biobased product.
For example, it is possible that a label
placed on a container will refer to the
container itself (in which case the
statement ‘‘Packaging: XX% biobased’’
would be used) or to the contents within
the container (Product: YY% biobased).
It may also be possible that both the
container and its contents are certified
biobased products, in which case two
statements would appear (Product:
YY% biobased. Packaging: XX%
biobased). Without tying the label to the
product or the packaging, the consumer
may be unable to determine which
product is the certified biobased
product. Therefore, USDA is proposing
that the appropriate statement(s) be
included in the label in order to identify
clearly the product or products to which
the label applies.
Furthermore, the proposed rule
requires that, at the time the label is
affixed to the product or its packaging,
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the biobased content shown on the label
is the same as the biobased content
found in the approved application for
the product. It is possible, however, that
the biobased content of a certified
product could be changed by the
manufacturer. If a certified product’s
biobased content is changed to a level
below that shown on the label, the
product is considered a reformulated
product and a new application is
required. If a certified product’s
biobased content is increased and the
manufacturer wishes to change the label
to the higher value, a new application
is also required.
USDA also requires manufacturers
and vendors to include the USDA
BioPreferred Web site address on or in
close proximity to the label. USDA is
not proposing to require that the Web
site address be on the label itself
because the label on many products will
not be large enough to accommodate
this extra information. USDA believes
that, where practicable, the presence of
the USDA BioPreferred Web site address
on the label will assist consumers in
obtaining information about biobased
products.
Physical Aspects of the Label
The rule addresses the physical
aspects of the label artwork and the
presentation of the biobased product
statement. In addition to the
requirements of the rule, USDA
anticipates that guidance on specific
issues related to the physical aspects of
the label will be provided in the
Marketing Guide.
Label Artwork
To maintain the distinctiveness of the
label artwork (which consists of the
logo, the phrase ‘‘USDA Certified
Biobased Product’’ and, where
applicable, the letters ‘‘FP’’) and to
make sure that it is readily recognizable,
USDA has established requirements
related to the physical appearance of the
label artwork. The applicable label
artwork provided by the BioPreferred
Program must be used.
USDA is also proposing color
requirements to ensure that the label
artwork remains distinctive and
recognizable. USDA is proposing to
require that one of three label versions
be used, depending on the need of the
product. (1) A three-color version of the
label artwork (white plus two shades of
green); (2) a one-color version of the
label artwork as long as the color used
is one of the two greens specified in
section 2904.7(f) of today’s proposed
rule; and (3) a black and white version
of the label artwork is also acceptable.
The contrast between the light and dark
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‘‘XX%,’’ where XX% represents the
actual biobased content of the product.
The biobased content must be easily
readable. Figure 1 illustrates the
placement of the biobased product
statement.
label’s color is similar to the background
color, an outlining color may be used to
enhance contrast.
facilities, visiting retail facilities, and
testing the biobased content of certified
biobased products. Visiting
manufacturer and vendor facilities and
inspecting their records, for example,
will help USDA identify potential label
and application violations. Testing
certified biobased products for their
biobased contents will help USDA
determine any violations associated
with biobased contents. Manufacturers,
vendors, and their designated
representatives are required to cooperate
fully with all USDA audit efforts for the
enforcement of the voluntary labeling
program. USDA envisions selecting five
to ten percent of labeled products at
random for audit each year.
Both the violations being proposed
and any penalties associated with a
violation would be applied on a per
product basis. For example, a
manufacturer has two certified biobased
products, Product A and Product B. The
manufacturer has been cited for a
labeling violation for Product A and the
certification for Product A has been
revoked. As proposed, the manufacturer
would be required to discontinue
labeling Product A, and USDA would
remove the information for Product A
from the USDA BioPreferred Web site.
If no actions were taken against the
manufacturer with regard to Product B,
the manufacturer’s certification for
Product B would not be affected by the
violation associated with Product A.
Thus, the manufacturer would still be
allowed to affix the label to Product B,
and Product B’s information would
Minimum Size and Clear Space
Recommendations for the Label
USDA recognizes that a specific size
requirement for the label would not be
appropriate because of the variety of
sizes and shapes of products that may
be certified. Therefore, the label may be
sized to be appropriate for the particular
application as long as the correct
proportions are maintained and the
label remains legible.
A border of clear space must surround
the label and must be of sufficient width
to offset it from surrounding images and
text and to avoid confusion. If the
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Where To Obtain Copies of the Label
Artwork
The two versions of the label artwork
(with and without the letters ‘‘FP’’, as
applicable) will be available at the
USDA BioPreferred Web site. Only
manufacturers and vendors approved
for use of the label for certified biobased
products will be able to obtain the label
from the Web site. USDA will provide
the necessary access (through the notice
of certification) once a manufacturer or
vendor has provided USDA with the
required information, which USDA will
post to the USDA BioPreferred Web site,
for a product whose application for
certification has been approved by
USDA.
H. Violations
Although the decision to participate
in the certified biobased products
labeling program is voluntary,
compliance with the program
requirements and specifications will be
essential to the success of the program.
Proposed section 2904.8 identifies
examples of the types of actions that
would be violations of the labeling
program.
To enforce the provisions of the
voluntary labeling program, USDA will
implement an audit program. This audit
program will include, but not
necessarily be limited to, conducting
inspections of manufacturer and vendor
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Biobased product statement. The
applicable biobased product
statement(s), which identifies the
product(s) to which the label applies
and the biobased content(s), would be
placed below the label artwork. The
biobased content must be expressed as
Placement of the Label
Whether the label is placed directly
on a product, on associated packaging,
in user manuals, or in other material, it
should always be placed in a manner
that ensures that the label (label artwork
and biobased product statement(s)) can
be readily associated with the
applicable certified biobased product.
The label should not be placed in a
manner that is ambiguous about which
product is a certified biobased product
or that could indicate certification of a
non-certified product. If all products on
a printed page are certified biobased
products, the label may be placed
anywhere on the page. However, if a
printed page contains a mix of certified
biobased products and non-certified
products, the label must be placed in
close proximity to the certified biobased
products. An individual label located
near each certified biobased product
may be necessary to avoid confusion.
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sections of the label artwork should be
great enough to maintain the
distinctiveness of the design.
Finally, the label artwork may not be
altered, cut, separated into components,
or distorted in appearance or
perspective.
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remain on the USDA BioPreferred Web
site.
Finally, the appeals process described
previously is also applicable when a
notice of violation, suspension, or
revocation is issued.
Biobased Content Violations. As
noted earlier, as part of its audit
program, USDA will conduct random
tests of certified biobased products
taken from market shelves to determine
their biobased contents and compare the
results to a product’s applicable
minimum biobased content and the
biobased content reported by the
manufacturer or vendor in the approved
application. USDA will conduct such
testing using ASTM D6866, Standard
Test Methods for Determining the
Biobased Content of Natural Range
Materials Using Radiocarbon and
Isotope Ratio Mass Spectrometry
Analysis.
If the USDA testing shows that the
biobased content of a certified biobased
product is less than the applicable
minimum biobased content identified in
the approved application for the
product, then a violation of the labeling
regulations has occurred.
If USDA testing shows that the
biobased content of a certified biobased
product is less than that reported in the
approved application, but is still equal
to or greater than the applicable
minimum biobased content, USDA will
notify the manufacturer or vendor of its
results. USDA may forward the test
results to the Federal Trade Commission
for possible enforcement. The
manufacturer or vendor would then
have 30 days to submit a new
application, showing a revised biobased
content for the product. The revised
biobased content could be either the
biobased content from the USDA test or
a biobased content reported by the
manufacturer or vendor based on a new
test conducted by the manufacturer or
vendor. If the manufacturer or vendor
elects to conduct a new biobased
content test, the manufacturer or vendor
must test a current sample of the
product. Failure to provide a new
application (including new test results)
with a revised biobased content within
30 days of receipt of USDA’s written
notification would be considered a
violation.
USDA notes that if its testing shows
that the biobased content of a certified
biobased product is greater than the
biobased content reported in the
approved application, no violation
would have occurred. USDA will,
however, notify the manufacturer or
vendor of the results of the testing, ask
if they would like to submit a second
product test, and potentially be allowed
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to increase the biobased content shown
on their label.
Label Violations. Any usage or
display of the label that does not
conform to the requirements proposed
in section 2904.7 would be considered
a violation of the proposed labeling
regulations. For example, applying a
label to a product that does not have a
valid certification would be a label
violation.
Application Violations. Knowingly
providing false or misleading
information in any application for
certification of a biobased product
would be a violation of the proposed
labeling regulations. For example,
certifying in the application that the
product meets the definition of a
biobased product when it does not
would be an application violation.
USDA BioPreferred Web site
Violations. As proposed, failure to
provide to USDA updated information
on a certified biobased product when
the information for the certified
biobased product becomes outdated
(e.g., a change in a product’s biobased
content), would be a violation.
Notice of Violations and Associated
Actions. When a violation has been
identified, USDA will provide written
notification of the violation to the
applicable entity, which may be the
manufacturer, vendor, or its designated
representative or other entity. In all
instances, the manufacturer of the
product for which USDA has identified
the violation will also be notified. The
notice of violation will identify the
violation. In the case of biobased
content violations, the offending party
will then have 30 days from the date the
notice of violation is received to correct
the violation. For other types of
violations, the offending party will have
60 days from the date the notice of
violation is received to correct the
violation. The 30-day period for
resolving violations of biobased content
violations is more stringent than the 60day period allowed for resolving other
types of violations because biobased
content violations, whether intentional
or not, are viewed as misleading
consumers and could result in
inappropriately influencing their
purchasing decisions.
If the party receiving the notice of
violation is an ‘‘other entity,’’ USDA
will pursue remedies as provided for
under proposed section 2904.8(c). If the
party is a manufacturer, vendor, or one
of its designated representatives, USDA
will first pursue notices of suspension
and revocation, as discussed below.
USDA also reserves the right to pursue
other remedies as provided in
§ 2904.8(c).
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Suspension of Certification. After
receiving a notice of violation, if the
manufacturer, vendor, or designated
representative, as applicable, fails to
make the required corrections within 60
days (or 30 days, in the case of biobased
content violations), USDA will notify
the manufacturer or vendor of the
continuing violation and will suspend
USDA certification for that product. As
of the date the manufacturer or vendor
receives a notice suspending product
certification, the manufacturer or
vendor and any designated
representatives must not affix the label
to any of that product, or associated
packaging, not already labeled. Also, the
manufacturer or vendor must not
distribute any additional products
bearing the label after receiving a notice
of suspension of product certification.
When USDA suspends a product’s
certification, USDA will issue a press
release informing the public of the
suspension and will also remove the
information on that product from the
USDA BioPreferred Web site. If USDA
learns that entities whose certification
has been suspended continue to use the
label, USDA will refer that information
to the Federal Trade Commission for
enforcement.
In order to resume use of the label for
a product whose certification has been
suspended, the manufacturer, vendor, or
designated representative must correct
the violation and notify USDA that the
violation has been corrected within 30
days from receipt of the notice of
suspension and must receive approval
from USDA before use of the label can
be resumed. Once USDA has approved
the corrections to the violation, USDA
will restore the product information to
the USDA BioPreferred Web site.
Revocation of Certification. If a
manufacturer or vendor whose USDA
product certification has been
suspended fails to make the required
corrections within 30 days of the date of
the suspension, USDA will notify the
manufacturer or vendor that the
certification for that product is revoked.
As of the date that the manufacturer or
vendor receives the notice revoking
USDA certification, the manufacturer or
vendor and any designated
representatives must not affix the label
to any of that product, or associated
packaging, not already labeled. In
addition, the manufacturer or vendor
and its designated representatives are
prohibited from further sales of the
product to which the label has already
been affixed to any entity. However, if,
prior to receipt of a notification of
revocation, a manufacturer or vendor
has stored a supply of product with the
label that has already been sold to
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another entity, the manufacturer or
vendor must notify the entity of the
label revocation and allow the entity to
cancel the transaction. If a manufacturer
or vendor whose product certification
has been revoked wishes to use the
label, the manufacturer or vendor must
follow the procedures required for
original certification.
Other Remedies. In addition to the
suspension or revocation of the
certification to use the label, depending
on the nature of the violation, USDA
may pursue suspension or debarment of
the entities involved in accordance with
part 3017 of this title. USDA further
reserves the right to pursue any other
remedies available by law, including
any civil or criminal remedies, against
any entity that violates the provisions of
this part.
I. Recordkeeping Requirements
Manufacturers and vendors who
choose to participate in the voluntary
labeling program will be required to
keep certain records related to their
labeled biobased products. USDA
believes these records are necessary to
ensure compliance with the labeling
regulations. Manufacturers and vendors
may keep these records in either
electronic or hard copy format. The
records that must be kept include:
• The results of all tests, and any
associated calculations, performed to
determine the biobased content of the
product;
• The results, and the supporting
documentation, of industry standard
functional performance tests to support
product performance claims made by
the manufacturer or vendor;
• The results, and the supporting
documentation, of analyses the
manufacturer or vendor has performed
to support claims of environmental or
human health effects, life cycle costs,
and sustainability benefits of the
product;
• Documentation that the product for
which certification is sought meets the
definition of biobased product, as
defined in § 2904.2 of this part; and
• The date of the certification by
USDA and the dates when the biobased
content of certified biobased products
was tested.
Records created under the
requirements of today’s proposed rule
must be maintained for at least three
years beyond the end of the label
certification period (i.e., three years
beyond the period of time when
manufacturers and vendors cease using
the label). If electronic records are
maintained, they must be readily
accessible during an audit by USDA.
USDA believes that a three-year record
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retention period is the minimum
necessary to allow verification of the
information supporting active
certifications. Manufacturers, vendors,
and their designated representatives
must allow Federal representatives
access to these records for inspection
and copying during normal Federal
business hours to determine compliance
with the applicable regulations.
J. Reporting
USDA encourages manufacturers
certified to use the label to provide data
in order to enable USDA to estimate and
publicly report the benefits and general
effectiveness of the Voluntary Labeling
Program. The quantity, frequency, and
format of the data will be as the parties
mutually agree. Such data may include,
if and as available: (1) The total number
of units of each product shipped by
manufacturer for sale in the U.S., and
(2) the type of customer (e.g.,
government, other public institution,
private/corporate institution, private
individual) to whom such products
were sold.
USDA recognizes that manufacturers
and vendors may consider some of the
requested information to be
confidential. USDA stresses that
information claimed as confidential by
the manufacturer or vendor will not be
released and that individual
manufacturer or vendor data will not be
reported. Only summary information
regarding the benefits and impacts of
the entire program will be released.
IV. Suggested Comment Topics
USDA invites comment on any aspect
of today’s proposed requirements for the
voluntary labeling program for biobased
products. USDA invites specific
comments in the areas identified below.
1. Who can apply for the label? Under
the proposed rule, both manufacturers
and vendors of biobased products can
apply for use of the label for their
products. USDA is interested in
comments on whether it is appropriate
to include vendors as an entity eligible
to apply for use of the label. Some of the
requirements associated with approval
for use of the label will require
information generally only available to
the manufacturer. In addition, it is the
manufacturer, not the vendor, who
determines a product’s formulation and
production process. What issues would
a vendor face in complying with the
proposed rule in light of this?
2. Applicable minimum biobased
contents. For products (including
intermediate ingredients and feedstocks)
not within a designated item, USDA is
interested in comments associated with;
(a) the 51 percent applicable minimum
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biobased contents that products within
this category must meet in order to be
eligible for use of the label, and (b) the
procedure under which an applicant
can request an alternative applicable
minimum biobased content (i.e., an
applicable minimum biobased content
other than 51 percent).
3. The labeling of ‘‘complex
products.’’ In addition to the three
categories of products (products within
designated items, those that are not
within designated items, and those that
are intermediate ingredients and
feedstocks that are not within
designated items) that would be eligible
to use the label under today’s proposed
rule, USDA also intends to develop
provisions for the labeling of ‘‘complex
products’’ once several implementation
issues have been resolved. A complex
product is considered to be a finished,
consumer product that is composed of
many different types of components.
Examples of complex products would
be products such as computers, vacuum
cleaners, lawn mowers, and
automobiles. Each of these products
contains many component parts made of
different materials. For products such as
these, it may be feasible to produce one
or more of the component parts with
biobased materials.
Today’s proposed rule does not
contain provisions to allow for the
labeling of complex products because
there is currently no approved method
to determine the biobased content of a
complex product. USDA has consulted
with ASTM representatives regarding
the lack of an approved test method.
ASTM is gathering information on
complex products and they intend to
proceed with the development of a
method that can be used to determine
the biobased content of complex
products. USDA will continue to work
closely with ASTM and the
manufacturers of complex products and,
once an acceptable test method is
available, expects to amend the
voluntary labeling rule to allow for the
labeling of complex products.
USDA requests that commenters
provide information on the types of
complex products containing biobased
components that are in the marketplace
today, as well as those which may be in
the developmental stage. Information on
the types of components that contain
biobased materials, the typical biobased
content of these components, and the
market share of the biobased
components is requested by USDA.
Information on current research efforts
to develop new biobased components
for complex products is also requested.
USDA is also interested in commenters’
opinions regarding how complex
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products and their biobased
components should be addressed in the
designation process as well as the
voluntary labeling program.
4. The labeling of ‘‘mature market
products.’’ The proposed rule does not
allow the label to be applied to products
that are considered to be ‘‘mature
market products’’ (i.e., products that
had significant market penetration in
1972), except on a case-by-case basis.
Section 2902.5(c)(2) of the final
Guidelines also excludes mature market
products from the designation process.
However, USDA is proposing to allow
manufacturers of mature market
products to appeal (on a case-by-case
basis) the exclusion of their products
from the voluntary labeling program if
they believe that conditions justify
special consideration for their products.
A possible example would be the
manufacturer of a traditional biobased
product that had a significant market
share in 1972, lost that market share to
petroleum-based alternative products
during the years between 1980 and
2000, is now attempting to re-enter the
market, and believes the label will be
helpful in this attempt. Other instances
where USDA might consider granting
appeals of the exclusion of mature
market products include those where
labeling a product could be shown to:
reduce dependence on foreign
petroleum sources; create new ‘‘green’’
jobs; or reduce greenhouse gas
emissions.
USDA welcomes comment on
whether mature market products should
be eligible for labeling and whether the
labeling of mature market products
could negatively affect the entry of new
(i.e., post-1972) biobased products into
market segments in which mature
products already have significant
market shares. USDA also requests
comments regarding what criteria
should be used to evaluate appeals to
include mature market products in the
labeling program and what types of
information manufacturers and vendors
should be required to submit as
justification for their appeal.
Commenters should provide specific
reasons why the use of the label on
mature market products should be
considered, including information on
the expected benefits of the label. USDA
is also seeking comments on why this
label might be preferred over, or how it
could be used in conjunction with,
other available labels such as the
‘‘cotton,’’ ‘‘renewable,’’ or ‘‘organic’’
labels that can be used on many mature
market products.
5. The appropriate lengths for the
certification periods. USDA is proposing
that certifications remain valid for as
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long as the certified product is
manufactured in accordance with the
approved application. USDA considered
a certification of either three or five
years, but chose not to propose a
specified time period, primarily to
reduce the burden that would be
associated with reapplying for
certification. USDA welcomes
comments on the appropriate length of
time that a certification should be valid.
Be sure to include rationale for any
recommendations of alternative
certification periods.
6. Preliminary notice of violations.
USDA welcomes comments on whether
a preliminary notice of violation for any
of the proposed violations should be
issued before action is taken by USDA
against the violators and, if so, how long
a violator should be given to correct the
violation before action is taken.
7. Biobased content testing facilities.
USDA solicits comments on the
appropriateness of requiring that labs be
ISO 9001 conformant. Specifically, are
there benefits in such a requirement in
terms of the quality of the resulting data
and, if so, is ISO 9001 the appropriate
standard? Commenters are encouraged
to provide their opinions on whether
there are other standards (such as ISO
17025) that would be more appropriate.
8. Clarification of biobased content of
product vs. packaging on label. As
discussed earlier in this preamble,
USDA believes that it is important to
identify for the consumer the item to
which the label applies. Therefore,
USDA is proposing that the label
include the appropriate biobased
product statement(s) to make this clear.
USDA seeks comments to determine if
the use of the word ‘‘product’’ in the
statement ‘‘Product: YY% biobased’’ is
clear enough. For example, if the label
applies to a biobased hydraulic fluid,
but not to its container, does the
statement ‘‘Product: YY% biobased’’
found on the container clearly convey
that the label applies to the hydraulic
fluid and not the container? If this
statement does not clearly convey this,
please suggest alternatives that would
more clearly accomplish this.
When the label applies to both the
product and its packaging, is it
necessary to provide the biobased
content of both the product and its
packaging? As proposed, two statements
would be included on the label
(Product: YY% biobased. Packaging:
XX% biobased). USDA welcomes
suggestions on how to address
providing biobased content information
when the label applies to both the
product and its packaging.
9. Identifying products that are also
eligible for a Federal procurement
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38307
preference under the preferred
procurement program. As proposed,
biobased products that fall within
designated items and are, therefore,
eligible for Federal preferred
procurement, would use a label with the
letters ‘‘FP’’ included in the label
artwork. USDA considered simply
allowing manufacturers to indicate in
the product’s literature that the product
is eligible for preferred procurement
rather than requiring such information
on the label itself. USDA decided that
there may be a benefit to either Federal
agencies or to the public consumers to
have this information on the label.
USDA is seeking comments on whether
the ‘‘FP’’ lettering on the label will be
sufficient to distinguish products that
are eligible for Federal preferred
procurement. USDA is also requesting
comments on whether consumers will
recognize that the lettering on products
means that these products, or similar
products, have undergone life cycle
costs and environmental performance
analyses. USDA also welcomes
comments on how the labeling program
and the preferred Federal procurement
program should work together.
10. Other possible label content. As
discussed above, USDA is proposing
that the label include the biobased
content (expressed as a percentage), a
statement indicating whether the
biobased content refers to the product or
the packaging or both, and the
BioPreferred Web site address (either on
or in close proximity to the label).
USDA also considered the possible
advantages and disadvantages of
requiring additional information on the
label. For example, USDA is proposing
that information on product
performance and on the life-cycle costs
and environmental and human health
effects of the labeled products be
maintained if manufactures make claims
regarding these attributes for their
products. USDA considered whether
providing this type of additional
information on the label would be
beneficial to purchasers.
The primary advantage of providing
additional information on the label is to
further educate purchasers about the
attributes of the biobased products they
choose to purchase. However, because
the results of these analyses would
typically be available only for labeled
biobased products, a comparison to nonlabeled biobased, or non-biobased,
competing products may often be
impossible. Also, the amount of space
that would be needed for a legible
presentation of this information could
be a serious drawback for many small
products (e.g., household cleaners, hair
care products, lip care products).
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USDA is proposing to require
manufacturers to include the
BioPreferred Web site address either on
or in close proximity to the label. USDA
is requesting comments on the possible
benefits of this proposed requirement
and also on any expected drawbacks or
negative impacts.
USDA requests comments and
recommendations regarding the value of
providing the types of additional
information discussed above on the
label and specifically requests input on
what types of information should be
included and how it should be
presented.
11. Legibility of the label. As
proposed, the label would consist of two
items, the label artwork and the
biobased product statement(s) with the
accompanying biobased content(s). This
is a significant amount of information
and, for some small products, could
result in a label that is difficult to read.
Therefore, USDA is seeking comment on
ways to help ensure that the information
proposed to be included will be legible.
Depending on the comments it receives
and the rationale behind those
comments, USDA may require a
different presentation of this
information.
12. Timeframe for correcting
violations. Under the proposed rule,
USDA would allow up to 60 days for
entities to correct violations (30 days for
biobased content violations) before a
notice of suspension or other remedy is
sought. USDA is seeking comment on
whether it is preferable for the
timeframe to correct a violation to be
fixed, including the appropriate length
to allow (e.g., are the 30- and 60-day
periods in the proposed rule
reasonable?) or to be determined on a
case-by-case basis to be specified in the
notice of violation.
13. Recordkeeping. The proposed rule
requires certain records be kept in order
to allow USDA to verify information
associated with the labeling program
and that these records be kept for at
least three years beyond the end of the
label certification period (i.e., three
years beyond the period of time when
manufacturers and vendors cease using
the label). USDA welcomes comments
on the specific records to be kept and
the length of time they must be kept,
including comments related to
recordkeeping costs.
14. Benefits and Costs. USDA requests
comments on the potential benefits
(social and private) and costs (e.g.,
testing, submitting applications and
associated information, and
recordkeeping) of the proposed rule.
15. Application Fee. USDA is
considering the option of charging an
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application fee for each application to
use the label. While Departmental
Administration does not currently have
the statutory authority to collect such a
fee, available options are being
explored. As discussed elsewhere in
this preamble, USDA plans to
implement an audit program to ensure
compliance with the requirements for
the use of the label. Based on experience
with other programs, USDA believes it
may be necessary to assess user fees in
order to maintain a viable audit
program. The proceeds from the
application fee would, therefore, be
used to help offset the cost of the audit
program. USDA believes that it is in the
best interest of not only USDA but also
the manufacturers of labeled products
that an audit program be implemented
so that the integrity of the label can be
assured. Were authority provided to do
so, USDA would consider charging a fee
of $500 for each submitted application
and requests comments on the
appropriateness of that amount as well
as on the charging of a fee at all.
Please be sure to include your
rationale for all suggested changes to the
proposed rule. Comments must be
submitted as directed in the ADDRESSES
section of this notice.
V. Regulatory Information
A. Executive Order 12866: Regulatory
Planning and Review
Executive Order 12866 requires
agencies to determine whether a
regulatory action is ‘‘significant.’’ This
proposed rule has been reviewed under
Executive Order (EO) 12866 and has
been determined to be significant.
Today’s proposed rule establishes a
voluntary labeling program that allows
manufacturers and vendors of certified
biobased products to use the ‘‘USDA
Certified Biobased Product’’ label.
Although the labeling program is
voluntary, there will be costs associated
with meeting the criteria for, and
applying for, certification to use the
label.
1. Costs of the Proposed Rule
The primary costs associated with
participating in this program are those
for developing applications, testing to
document the biobased content of
products, providing information to
USDA for posting by USDA on the
USDA BioPreferred Web site,
maintaining applicable records, and
redesigning the product packaging to
incorporate the label. USDA estimates
that the combined annualized cost of
the voluntary program, as proposed, to
manufacturers and vendors would
average approximately $2,813,811 per
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year for the first three years of the
program. USDA estimates an average of
352 manufacturers and vendors per year
will submit applications to participate
in the labeling program for the first
three years of the program. This yields
an average annualized cost per
manufacturer/vendor of approximately
$7,994.
The level of presumed impact is not
expected to exceed $100 million
because of the offsetting nature of the
labeling program (i.e., an increase in
demand for biobased products is likely
to be offset by a decrease in demand for
non-biobased products). While the
program is anticipated to have a
widespread effect on the marketplace
(including shifting purchases away from
non-biobased products toward the
purchase of biobased products), it is not
expected to have a widespread adverse
effect on the economy.
2. Benefits of the Proposed Rule
As an integral part of USDA’s
BioPreferredSM Program, the voluntary
labeling program is expected to raise
public awareness of, and increase the
demand for, biobased products. While
the benefits of the labeling program are
not quantifiable at this time, an
increased demand for biobased products
will, in turn, achieve the benefits as
outlined in the objectives of section
9002: To increase domestic demand for
many agricultural commodities that can
serve as feedstocks for production of
biobased products; to spur development
of the industrial base through valueadded agricultural processing and
manufacturing in rural communities; to
enhance the Nation’s energy security by
substituting biobased products for
products derived from imported oil and
natural gas; and to substitute products
with a possibly more benign or
beneficial environmental impact, as
compared to the use of fossil energybased products. On a national and
regional level, today’s proposed rule can
result in expanding and strengthening
markets for biobased materials used in
these items. The program is also
expected to promote economic
development for biobased product
manufacturers and vendors by creating
new jobs and providing new markets for
farm commodities.
B. Regulatory Flexibility Act (RFA)
Under the RFA, an agency is not
required 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 if the
agency can certify that the rule will not
have a significant economic impact on
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a substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
Of these three types of entities, the
labeling requirements in today’s
rulemaking would be applicable to
small businesses only. For purposes of
assessing the impacts on small entities,
a small business is defined by the RFA
using the definitions for small business
based on Small Business Administration
size standards, which vary depending
on the type of business (e.g., less than
500 employees, less than 1,000
employees). Most of the manufacturing
companies and vendors associated with
products within items that USDA has
designated or proposed for designation
would qualify as small businesses under
SBA guidelines.
While we do not have enough
information to evaluate fully the
potential effect of this proposed rule on
small entities, we have some
information to make some initial
conclusions. We identified six North
American Industrial Classification
System (NAICS) categories under which
many biobased products are
manufactured: Petroleum lubricating oil
and grease manufacturing, plastics
material and resin manufacturing, soap
and other detergent manufacturing,
urethane and other foam product
(except polystyrene) manufacturing,
carpet and rug mills manufacturing, and
fertilizer manufacturing. We then used
economic census data to determine the
average value of shipments, a reasonable
surrogate for annual sales, for
companies in these categories. The
analysis indicates that the average value
of shipments in 2002, the most recent
year for which there are complete
census data, for the six NAICS
categories examined is over $10 million
per year per establishment. USDA
requests comments on the quality of this
analysis and ways to improve it.
More recent manufacturing census
data on firm size, from 2006, indicates
that, collectively, over 94 percent of the
firms in the six categories meet the
Small Business Administration
definition of small business for the six
categories.
The benefit-cost analysis USDA
conducted for the proposed rule,
discussed in Section I. below, indicates
that the annualized cost associated with
participating in the voluntary labeling
program is about $7,994 on average and,
relative to total sales by small
businesses in the NAICS categories
where many biobased products are
manufactured, appears not to represent
an undue burden in most cases.
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Moreover, participation in the
voluntary labeling program would
provide manufacturers and vendors a
marketing advantage over those who
choose not to participate. This
marketing advantage could lead to
greater sales, thus offsetting some of the
costs associated with participating in
the labeling program.
Finally, the program requirements for
the voluntary labeling program are
applicable to all manufacturers and
vendors of biobased products seeking to
use the label under this program,
regardless of the size of their business.
For instance, all manufacturers and
vendors are required to submit an
application, conduct certain testing, and
provide to USDA certain information
that USDA will post to the BioPreferred
Web site. These requirements are
necessary to certify biobased products
and are independent of the size of the
manufacturer or vendor. The integrity of
the labeling program would be
compromised if biobased products
manufactured by small businesses were
allowed to be subject to different criteria
in order to reduce costs to small
businesses.
Based on this initial analysis, USDA
has not prepared a Regulatory
Flexibility Analysis because USDA has
determined that this rule does not have
a significant impact on a substantial
number of small entities.
C. Executive Order 12630:
Governmental Actions and Interference
With Constitutionally Protected Property
Rights
This proposed rule has been reviewed
in accordance with Executive Order
12630, Governmental Actions and
Interference with Constitutionally
Protected Property Rights, and does not
contain policies that would have
implications for these rights.
D. Executive Order 13132: Federalism
This proposed rule does not have
sufficient Federalism implications to
warrant the preparation of a Federalism
Assessment. Provisions of this proposed
rule will not have a substantial direct
effect on States or their political
subdivisions or on the distribution of
power and responsibilities among the
various government levels.
E. Unfunded Mandates Reform Act of
1995
This proposed rule contains no
Federal mandates as defined under the
regulatory provisions of Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA), 2 U.S.C. 1531–1538, for State,
local, and tribal governments, or the
private sector. Therefore, a statement
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under section 202 of UMRA is not
required.
F. Executive Order 12372:
Intergovernmental Review of Federal
Programs
For the reasons set forth in the Final
Rule Related Notice for 7 CFR part 3015,
subpart V (48 FR 29115, June 24, 1983),
this program is excluded from the scope
of Executive Order 12372, which
requires intergovernmental consultation
with State and local officials. This
program does not directly affect State
and local governments.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Today’s proposed rule does not
significantly or uniquely affect the
communities of Indian tribal
governments. The proposed rule does
not impose any mandate on tribal
governments or impose any duties on
these entities. Thus, no further action is
required under Executive Order 13175.
H. Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), USDA is seeking OMB approval
of the reporting and recordkeeping
requirements contained in this proposed
rule. USDA conducted a burden
analysis of the costs associated with this
proposed rule, as well as a benefit-cost
analysis. The primary costs of
participating in the voluntary labeling
program are the costs of testing the
biobased content of products and the
costs of labor associated with reading
the rule, applying for certification,
gathering and submitting the
information for posting to the
BioPreferred Web site, and keeping
applicable records for the products for
which certification is sought. See the
contact information at the end of this
section for details on how to request a
copy of materials related to the
Information Collection Request.
Methodology
To estimate the average annual
burden over the first three years of the
rule, USDA estimated the number of
hours that each activity (e.g., read the
rule, complete the application, submit
information to USDA, appeal denied
applications, keep records) would take,
summed the estimates for each activity
to get an average total number of hours
per manufacturer/vendor, and
multiplied that total by the estimated
number of manufacturers/vendors. The
total cost of biobased content testing
was then projected by multiplying the
estimated total number of biobased
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products for which certification is
expected to be sought by the cost of the
test. The labor component of the cost
and the testing component were then
summed to give a total estimated
burden.
Assumptions
In estimating the costs for the burden
analysis, USDA made the following
assumptions.
1. In the first year of the voluntary
labeling program, USDA estimates that
100 items will have been designated as
eligible to receive the procurement
preference, another 36 items will have
been designated in the second year of
the labeling program, and another 30
items will have been designated in the
third year of the labeling program.
2. Based on information gathered
during the item designation
rulemakings, USDA estimates that
approximately 830 manufacturers of
products within these 166 designated
items and an additional 830
manufacturers of biobased products
(including intermediate ingredients or
feedstocks) within items that are not
designated for preferred procurement
are expected to have an interest in using
the label, yielding 1,660 manufacturers
with eligible biobased products over the
first three years. USDA estimates that an
additional 200 vendors over the first
three years would be interested in the
voluntary labeling program. This yields
a total of 1,860 manufacturers and
vendors. Finally, USDA estimates that
166 other entities over the first three
years would be interested in the
voluntary labeling program.
3. Because the voluntary labeling
program is new and the benefits to
manufacturers of labeling their biobased
products are not yet demonstrated,
USDA anticipates that many
manufacturers may be reluctant to
participate during the first few years of
the program. USDA expects that during
the first three years of the program,
participation by one half to two thirds
of eligible manufacturers/vendors
would be a reasonable estimate.
Therefore, USDA assumed that sixty
percent of the manufacturers of
products within designated items, sixty
percent of the manufacturers of
products that are not within designated
items, and thirty percent of the vendors
with eligible biobased products would
apply for certification to use the label.
Thus, 1,056 manufacturers and vendors
((830 × 0.6) + (830 × 0.6) + (200 × 0.3)
= 1,056) would apply to use the label
over the first three years (an average of
352 per year).
4. Based on information gathered to
support the designation of items for
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preferred procurement, the average
number of biobased products per
manufacturer is between six and seven.
For this analysis, USDA estimates that
each applicant would submit
applications for six products. This
results in the submittal of 2,112
applications (352 applicants times 6
products per applicant) for products, on
average, for each of the first three years.
Of these, USDA estimates that 95
percent will be approved for use of the
label.
5. In estimating the cost of the labor
for reading the rule, completing
applications, gathering and submitting
information for posting on the
BioPreferred Web site, and maintaining
the applicable records, USDA used an
average labor cost of $49.98 per hour.
This hourly rate is based on the Federal
salary schedule, step 6, GS 14 ‘‘rest of
the United States’’ salary of $103,957
per annum (with 2080 hours worked per
annum). The salary level is deemed
reasonable under the expectation that at
least half the burden hours would likely
be provided by private sector employees
earning less than this hourly rate and up
to half the private sector employees
would be earning more.
6. Based on the biobased content
testing performed to support the item
designation rulemakings, USDA
estimated an average cost of $500 to
perform biobased content testing.
Estimated Burden
During the first three years the
labeling program is in effect, the total
annual burden on all respondents is
estimated to be $2,813,811. For the
estimated 352 manufacturers/vendors
(see item 3 above) certified to use the
label, the average burden is, therefore,
estimated to be $7,994 ($2,813,811 ÷ 352
= $7,994).
Abstract
The Farm Security and Rural
Investment Act of 2002 (2002 Act), as
amended by the Food, Conservation,
and Energy Act of 2008, established the
Biobased Markets Program under Title
IX, Section 9002. The 2002 Act requires
the Secretary of Agriculture to create a
voluntary labeling program for biobased
products.
The information requirements
contained in this proposed rule require
information from manufacturers and
vendors of biobased products that seek
to use the label on qualified biobased
products. The information is vital for
USDA to evaluate the qualifications of
biobased products to carry the USDA
label and to ensure that the label is used
properly. This collection of information
is necessary in order to implement the
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voluntary labeling program for biobased
products established under the 2002
Act.
Copies of this information collection
can be obtained from Ron Buckhalt at
the following address: Ron Buckhalt,
USDA, Office of the Assistant Secretary
for Administration, Room 300,
Reporters Building, 300 Seventh Street
SW., Washington, DC 20024; e-mail:
biopreferred@usda.gov; phone (202)
205–4008.
As part of our continuing effort to
reduce paperwork and respondent
burdens, USDA invites the public and
other Federal agencies to comment on
any aspect of the reporting burden in
the proposed rule. Comments are
invited on: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of USDA in the operation and
management of this labeling program;
(2) the accuracy of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology. Comments may be sent to:
Office of Information and Regulatory
Affairs of OMB, Attention: Desk Officer
for Agriculture, Margaret Malanoski,
725 17th Street, NW., Room 10202,
Washington, DC 20503. Comments
should reference OMB control number
0503–NEW. All responses to this notice
will be summarized and included in the
request for OMB approval. All
comments will also become a matter of
public record.
I. Government Paperwork Elimination
Act Compliance
USDA is committed to compliance
with the Government Paperwork
Elimination Act (GPEA) (44 U.S.C. 3504
note), which requires Government
agencies in general to provide the public
the option of submitting information or
transacting business electronically to
the maximum extent possible. USDA is
implementing an electronic information
system for posting information
submitted by manufacturers and
vendors on the products they intend to
label under the voluntary labeling
program for biobased products. For
information pertinent to GPEA
compliance related to this rule, please
contact Ron Buckhalt at (202) 205–4008.
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J. Small Business Regulatory
Enforcement Fairness Act
The proposed rule is not a major rule
under the Small Business Regulatory
Enforcement Fairness Act, 5 U.S.C.
804(2). This rule will not have an
annual effect on the economy of $100
million or more; will not cause a major
increase in costs or prices for
consumers, individual industries,
Federal, State, or local government
agencies, or geographic regions; and
does not have significant adverse effects
on competition, employment,
investment, productivity, innovation, or
the ability of U.S.-based enterprises to
compete with foreign-based enterprises.
List of Subjects in 7 CFR Part 2904
Biobased products, Labeling.
For the reasons stated in the
preamble, the U.S. Department of
Agriculture (USDA) proposes to amend
7 CFR chapter XXIX as follows:
CHAPTER XXIX—DEPARTMENTAL
ADMINISTRATION, DEPARTMENT OF
AGRICULTURE
1. A new part 2904 is added to
chapter XXIX to read as follows:
PART 2904—VOLUNTARY LABELING
PROGRAM FOR BIOBASED
PRODUCTS
Sec.
2904.1 Purpose and scope.
2904.2 Definitions.
2904.3 Applicability.
2904.4 Criteria for product eligibility to use
the label.
2904.5 Initial approval process.
2904.6 Appeals process.
2904.7 Requirements for the use of the
label.
2904.8 Violations.
2904.9 Recordkeeping requirements.
2904.10 Oversight and monitoring.
Authority: 7 U.S.C. 8102.
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§ 2904.1
Purpose and scope.
The purpose of this part is to set forth
the terms and conditions for voluntary
use of the ‘‘USDA Certified Biobased
Product’’ label. This part establishes the
criteria that biobased products must
meet in order to be eligible to become
certified biobased products to which the
‘‘USDA Certified Biobased Product’’
label can be affixed, the process
manufacturers and vendors must use to
obtain and maintain USDA certification,
and the recordkeeping requirements for
manufacturers and vendors who obtain
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certification. In addition, this part
establishes specifications for the correct
and incorrect uses of the label, which
apply to manufacturers, vendors, and
other entities. Finally, this part
establishes actions that constitute
voluntary labeling program violations.
§ 2904.2
Definitions.
Applicable minimum biobased
content. The biobased content at or
above the level set by USDA to qualify
for use of the label.
ASTM International (ASTM). A
nonprofit organization that provides an
international forum for the development
and publication of voluntary consensus
standards for materials, products,
systems, and services.
Biobased content. The amount of
biobased carbon in the material or
product expressed as a percent of
weight (mass) of the total organic carbon
in the material or product. For products
within designated items, the biobased
content shall be defined and determined
as specified in the applicable section of
subpart B of part 2902. For all other
products, the biobased content is to be
determined using ASTM Method D6866,
Standard Test Methods for Determining
the Biobased Content of Natural Range
Materials Using Radiocarbon and
Isotope Ratio Mass Spectrometry
Analysis.
Biobased product. A product
determined by the Secretary to be a
commercial or industrial product (other
than food or feed) that is:
(1) Composed, in whole or in
significant part, of biological products,
including renewable domestic
agricultural materials and forestry
materials; or
(2) An intermediate ingredient or
feedstock. For the purposes of this
subpart, the term ‘biobased product’
does not include motor vehicle fuels,
heating oil, electricity produced from
biomass, or any mature market
products. Products from a mature
market will be determined on a case-bycase basis.
Certified biobased product. A
biobased product for which the
manufacturer or vendor of the product
has received approval from USDA to
affix to the product the ‘‘USDA Certified
Biobased Product’’ label.
Days. As used in this part means
calendar days.
Designated item. For the purposes of
this part means a generic grouping of
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biobased products designated for
preferred procurement under subpart B
of part 2902 of this title.
Designated representative. An entity
authorized by a manufacturer or vendor
to affix the USDA label to the
manufacturer’s or vendor’s certified
biobased product or its packaging.
Intermediate ingredients or
feedstocks. A material or compound
made in whole or in significant part
from biological products, including
renewable agricultural materials
(including plant, animal, and marine
materials) or forestry materials, that are
subsequently used to make a more
complex compound or product. For the
purposes of this subpart, intermediate
ingredients or feedstocks do not include
raw agricultural or forestry materials,
but represent those materials that can be
put into a new cycle of production and
finishing processes to create finished
materials, ready for distribution and
consumption.
ISO. The International Organization
for Standardization, a network of
national standards institutes working in
partnership with international
organizations, governments, industries,
business, and consumer representatives.
ISO 9001 conformant. An entity that
meets all of the requirements of the ISO
9001 standard, but that is not required
to be ISO 9001 certified. ISO 9001 refers
to the International Organization for
Standardization’s standards and
guidelines relating to ‘‘quality
management’’ systems. ‘‘Quality
management’’ is defined as what the
manufacturer does to ensure that its
products or services satisfy the
customer’s quality requirements and
comply with any regulations applicable
to those products or services.
Label. Collectively, the label artwork
(as defined in this section) and the
biobased product statement(s),
including the applicable biobased
content(s).
Label artwork. The certification
marks, ‘‘USDA Certified Biobased
Product’’ and the ‘‘USDA Certified
Biobased Product’’ logo, and, where
applicable, the letters ‘‘FP’’ to indicate
that the product is within a designated
item and eligible for Federal preferred
procurement, as shown in Figure 1.
Application of either certification mark
by a manufacturer or vendor signifies
that USDA has certified that the product
meets the qualifications in this part.
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Manufacturer. An entity that performs
the necessary chemical and/or
mechanical processes to make a final
marketable product.
Mature market products. Biobased
products that are not eligible for
designation for BioPreferred preferred
procurement or labeling as defined
under subpart B of part 2902 of this title
because they had significant national
market penetration in 1972. The
eligibility of mature market products for
the voluntary labeling program will be
considered on a case-by-case basis,
based on manufacturer’s or vendor’s
appeal of the exclusion.
Other entity. Any person, group,
public or private organization, or
business other than USDA, or
manufacturers or vendors of biobased
products that may wish to use the
‘‘USDA Certified Biobased Product’’
label in informational or promotional
material related to a certified biobased
product.
Program Manager. The manager of the
BioPreferred Program.
USDA. The United States Department
of Agriculture.
Vendor. An entity that offers for sale
final marketable biobased products that
are produced by manufacturers.
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§ 2904.3
Applicability.
(a) Manufacturers, vendors, and
designated representatives. The
requirements in this part apply to all
manufacturers and vendors, and their
designated representatives, who wish to
participate in the USDA voluntary
labeling program for biobased products.
Manufacturers and vendors wishing to
participate in the voluntary labeling
program are required to obtain and
maintain product certification.
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(b) Other entities. The requirements in
this part apply to other entities who
wish to use the label in promoting the
sales or the public awareness of certified
biobased products.
§ 2904.4 Criteria for product eligibility to
use the label.
A product must meet each of the
criteria specified in paragraphs (a) and
(b) of this section in order to be eligible
to receive biobased product
certification.
(a) Biobased product.
(1) Except as specified in paragraph
(a)(2) of this section, the product for
which certification is sought must be a
biobased product as defined in § 2904.2
of this part.
(2) Products that meet the definition
of mature market products, as defined in
§ 2904.2 of this part, will be considered
for certification only in those cases
where the Program Manager sustains an
appeal by the manufacturer or vendor of
the product for inclusion in the
voluntary labeling program, as specified
in § 2904.6(c) of this part.
(b) Minimum biobased content. The
biobased content of the product must be
equal to or greater than the applicable
minimum biobased content, as
described in paragraphs (b)(1) through
(b)(4) of this section.
(1) Biobased products within
designated items.
(i) Product is within a single
designated item. If the product is within
a single item that, at the time the
application for certification is
submitted, has been designated by
USDA for preferred procurement, the
applicable minimum biobased content
is the minimum biobased content
specified for the item as found in
subpart B of 7 CFR part 2902.
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(ii) Product is within multiple
designated items. If a biobased product
is marketed within more than one
designated item, uses the same
packaging for each designated item, and
the applicant seeks certification of the
product, the product’s biobased content
must meet or exceed the specified
minimum biobased content for each of
the applicable designated items in order
to use the label on the product.
However, if the manufacturer packages
the product differently for each
designated item then the applicable
minimum biobased contents are those
established under paragraph (b)(1)(i) of
this section for each designated item for
which the applicant seeks to use the
label.
(2) Finished biobased products that
are not within designated items.
(i) If the product is not an
intermediate ingredient or feedstock and
is not within a designated item at the
time the application for certification is
submitted, the applicable minimum
biobased content is 51 percent.
Manufacturers, vendors, groups of
manufacturers and/or vendors, and
trade associations may propose an
alternative applicable minimum
biobased content for the product by
developing, in consultation with USDA,
and conducting an analysis to support
the proposed alternative applicable
minimum biobased content. If approved
by USDA, the proposed alternative
applicable minimum biobased content
would become the applicable minimum
biobased content for the product.
(ii) If a product certified under
paragraph (2)(i) of this section is within
an item that USDA subsequently
designates for preferred procurement,
the applicable minimum biobased
content shall become, as of the effective
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date of the final designation rule, the
minimum biobased content specified for
the item as found in subpart B of 7 CFR
part 2902.
(3) Products that are intermediate
ingredients or feedstocks and are not
within designated items.
(i) If the product is an intermediate
ingredient or feedstock that is not
within a designated item at the time the
application for certification is
submitted, the applicable minimum
biobased content is 51 percent.
(ii) If a product certified under
paragraph (3)(i) of this section is within
an item that USDA subsequently
designates for preferred procurement,
the applicable minimum biobased
content shall become, as of the effective
date of the final designation rule, the
minimum biobased content specified for
the item as found in subpart B of 7 CFR
part 2902.
(4) [reserved]
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§ 2904.5
Initial approval process.
(a) Application. Manufacturers and
vendors seeking USDA certification to
use the label for an eligible biobased
product must submit a USDA-approved
application for certification for each
biobased product. A standardized
application form and instructions are
available on the USDA BioPreferred
Web site (https://www.biopreferred.gov).
The contents of an acceptable
application are as specified in
paragraphs (a)(1) through (3) of this
section.
(1) General content. The applicant
must provide contact information and
product information including all brand
names or other identifying information,
biobased content and testing
information, product category, intended
uses, and, if applicable, the
corresponding designated item type.
The applicant must attach to the
application documentation
demonstrating that the reported
biobased content was tested by a thirdparty testing entity that is ISO 9001
conformant.
(2) Certifications. The applicant must
certify in the application that the
product for which use of the label is
sought is a biobased product as defined
in § 2904.2 of this part.
(3) Commitments. The applicant must
sign a statement in the application that
commits the applicant to submitting to
USDA the information specified in
paragraph (c)(1) through (4) of this
section, which USDA will post to the
USDA BioPreferred Web site, and to
providing USDA with up-to-date
information for posting on this Web site.
(b) Evaluation of applications.
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(1) USDA will evaluate each
application to determine if it contains
the information specified in paragraph
(a) of this section. If USDA determines
that the application is not complete,
USDA will return the application to the
applicant with an explanation of its
deficiencies. Once the deficiencies have
been addressed, the applicant may
resubmit the application, along with a
cover letter explaining the changes
made, for re-evaluation by USDA. USDA
will evaluate resubmitted applications
separately from first-time applications,
and those with the earliest original
application submittal date will be given
first priority.
(2)(i) USDA will evaluate each
complete application to determine
compliance with the criteria specified in
§ 2904.4. USDA will provide a written
response to each applicant within 60
days after the receipt of a complete
application, informing the applicant of
whether the application has been
conditionally approved or has been
disapproved.
(ii) For those applications that are
conditionally approved, a notice of
certification, as specified in paragraph
(c) of this section, must be issued before
the use of the label can begin.
(iii) For those applications that are
disapproved, USDA will issue a notice
of denial of certification and will inform
the applicant in writing of each criterion
not met. Applicants who receive a
notice of denial of certification may
appeal using the procedures specified in
§ 2904.6.
(c) Notice of certification. After
notification that its application has been
conditionally approved, the applicant
must provide to USDA (for posting by
USDA on the USDA BioPreferred Web
site) the information specified in
paragraphs (c)(1) through (4) of this
section. Once USDA confirms that the
information is received and complete,
USDA will issue a notice of certification
to the applicant. Upon receipt of a
notice of certification, the applicant may
begin using the label on the certified
biobased product.
(1) The product’s brand name(s), or
other identifying information.
(2) Contact information, including the
name, mailing address, e-mail address,
and telephone number of the applicant.
(3) The biobased content of the
product.
(4) A hot link directly to the
applicant’s Web site (if available).
(d) Term of certification.
(1) The effective date of certification
is the date that the applicant receives a
notice of certification from USDA.
Except as specified in paragraphs (2)(i)
through (2)(iv) of this section,
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certifications will remain in effect as
long as the product is manufactured and
marketed in accordance with the
approved application and the
requirements of this subpart.
(2)(i) If the product formulation of a
certified product is changed such that
the biobased content of the product is
reduced to a level below that reported
in the approved application, the existing
certification will not be valid for the
product under the revised conditions
and the manufacturer or vendor, as
applicable, and its designated
representatives must discontinue
affixing the label to the product and
must not initiate any further advertising
of the product using the label. USDA
will consider a product under such
revised conditions to be a reformulated
product, and the manufacturer or
vendor, as applicable, must submit a
new application for certification using
the procedures specified in paragraph
(a) of this section.
(ii) If the product formulation of a
certified product is changed such that
the biobased content of the product is
increased from the level reported in the
approved application, and the
manufacturer wishes to report the
higher value on the label, a new
application must be submitted using the
procedures specified in paragraph (a) of
this section.
(iii) If the product formulation of a
certified product is changed such that
the biobased content of the product is
increased, but the label is not revised,
the existing certification will continue
to be valid for the product.
(iv) If the applicable required
minimum biobased content for a
product to be eligible to display the
label is revised by USDA, manufacturers
and vendors may continue to label their
previously certified product only if it
meets the new minimum biobased
content level. In those cases where the
biobased content of a certified product
fails to meet the new minimum
biobased content level, USDA will
notify the manufacturer or vendor that
their certification is no longer valid.
Such manufacturers and vendors must
increase the biobased content of their
product to a level at or above the new
minimum biobased content level and
must re-apply for certification within 60
days if they wish to continue to use the
label. Manufacturers and vendors who
have re-applied for certification may
continue using the existing label until
they receive notification from USDA on
the results of their re-application for
certification.
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§ 2904.6
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Appeal processes.
An applicant for certification may
appeal a notice of denial of certification
to the Program Manager. Entities that
have received a notice of violation, and
manufacturers and vendors of certified
biobased products who have received a
notice of suspension or revocation, may
appeal to the Program Manager.
Manufacturers and vendors of mature
market products may appeal the
exclusion of their products from the
voluntary labeling program to the
Program Manager.
(a)(1) Appeals to the Program Manager
must be filed within 30 days of receipt
by the appellant of a notice of denial of
certification, a notice of violation, a
notice of suspension, or a notice of
revocation. Appeals must be filed in
writing and addressed to: Program
Manager, USDA Voluntary Labeling
Program for Biobased Products, Room
300, Reporters Building, 300 Seventh
Street SW., Washington, DC 20024.
(2) All appeals must include a copy of
the adverse decision and a statement of
the appellant’s reasons for believing that
the decision was not made in
accordance with applicable program
regulations, policies, or procedures, or
otherwise was not proper.
(b)(1) If the Program Manager sustains
an applicant’s appeal of a notice of
denial of certification, USDA will issue
a notice of certification to the applicant
for its biobased product.
(2) If the Program Manager sustains a
manufacturer’s or vendor’s appeal of a
notice of violation, USDA will rescind
the notice and no further action will be
taken by USDA.
(3) If the Program Manager sustains a
manufacturer’s or vendor’s appeal of a
notice of suspension, the manufacturer,
vendors, and their designated
representative(s) may immediately
resume affixing the label to the certified
biobased product and USDA will
reinstate the product’s information to
the USDA BioPreferred Web site.
(4) If the Program Manager sustains a
manufacturer’s or vendor’s appeal of a
notice of revocation, the manufacturer
or vendor, and its designated
representatives may immediately
resume affixing the label to the certified
biobased product and sell and distribute
the certified biobased product with the
label. In addition, USDA will reinstate
the product’s information to the USDA
BioPreferred Web site.
(c)(1) Manufacturers or vendors of
mature market products may appeal the
exclusion of their products from the
voluntary labeling program if they
believe that special conditions or
circumstances warrant the inclusion of
their products in the program. Appeals
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to the Program Manager from
manufacturers or vendors of mature
market products must be filed in writing
and addressed to: Program Manager,
USDA Voluntary Labeling Program for
Biobased Products, Room 300, Reporters
Building, 300 Seventh Street, SW.,
Washington, DC 20024.
(2) Appeals for the inclusion of
mature market products must include
detailed justification showing why the
product should be allowed to use the
label.
(3) If the Program Manager sustains a
manufacturer’s or vendor’s appeal of its
product’s exclusion from the program,
the manufacturers or vendors may then
apply for certification to use the label on
that product, as specified in § 2904.5(a)
of this part.
(4) Mature market products that are
certified by USDA to use the label will
be considered to be ‘‘finished biobased
products that are not within designated
items’’ and subject to all provisions of
this part that are applicable to that
category of certified biobased products.
(d) Appeals of any of the Program
Manager’s decisions may be made to the
USDA Assistant Secretary for
Administration. Appeals must be made,
in writing, within 30 days of receipt of
the Program Manager’s decision and
addressed to: Assistant Secretary for
Administration, Room 209A, Whitten
Building, 1400 Independence Avenue,
SW., Washington, DC 20250–0103. If the
Assistant Secretary for Administration
sustains an appeal, the provisions of
paragraph (b) of this section will apply.
§ 2904.7
label.
Requirements associated with the
(a) Who may use the label?
(1) Manufacturers and vendors. Only
manufacturers and vendors who have
received a notice of certification, or
designated representatives of the
manufacturer or vendor, may affix the
label to the product or its packaging. A
manufacturer or vendor who has
received a notice of certification for a
product under this part:
(i) May use the label on the product,
its packaging, and other related
materials including, but not limited to,
advertisements, catalogs, procurement
databases, promotional material, Web
sites, or user manuals for that product,
according to the requirements set forth
in this section; and
(ii) is responsible for the manner in
which the label is used by its
companies, as well as its designated
representatives, including advertising
agencies and subcontractors.
(2) Other entities.
(i) Other entities may use the label to
advertise or promote certified biobased
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products in materials including, but not
limited to, advertisements, catalogs,
procurement databases, Web sites, and
promotional and educational materials,
as long as the manufacturer or vendor of
the product, or one of their designated
representatives, has affixed the label to
the product or its packaging.
(ii) Other entities may use the label
and the BioPreferred Program name in
general statements as described in
paragraph (b) of this section, as long as
the statements do not imply that a noncertified biobased product is certified.
(b) Correct usage of the label.
(1) The label can be affixed only to
certified biobased products and their
associated packaging.
(2) The label may be used in material
including, but not limited to,
advertisements, catalogs, procurement
databases, Web sites, and promotional
and educational materials to distinguish
products that are certified for use of the
label from those that are not certified.
The label may be used in
advertisements for both certified
biobased products and non-certified
products if the advertisement clearly
indicates which products are certified.
Care must be taken to avoid implying
that any non-certified products are
certified.
(3) The label may be used without
reference to a specific certified biobased
product only when informing the public
about the purpose of the label. For
example, the following or similar claim
is acceptable: ‘‘Look for the ‘USDA
Certified Biobased Product’ label. It
means that the product meets USDA
standards for the amount of biobased
content and the manufacturer or vendor
has provided relevant information on
the product for the USDA BioPreferred
Web site.’’ This exception allows
manufacturers, vendors, and other
entities to use the label in documents
such as corporate reports, but only in an
informative manner, not as a statement
of product certification.
(4) The label may appear next to a
picture of the product(s) or text
describing it.
(5) The label must stand alone and not
be incorporated into any other label or
logo designs.
(6) The label may be used as a
watermark provided the use does not
violate any usage restrictions specified
in this part.
(7) The text portion of the label must
be written in English and may not be
translated, even when the label is used
outside of the United States.
(c) Incorrect usage of the label.
(1) The label shall not be used on any
product that has not been certified by
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USDA as a ‘‘USDA Certified Biobased
Product.’’
(2) The label shall not be used on any
advertisements or informational
materials where both certified biobased
products and non-certified products are
shown unless it is clear that the label
applies to only the certified biobased
product(s).
(3) The label shall not be used to
imply endorsement by USDA or the
BioPreferred Program of any particular
product, service, or company.
(4) The label shall not be used in any
form that could be misleading to the
consumer.
(5) The label shall not be used by
manufacturers or vendors of certified
products in a manner disparaging to
USDA or any other government body.
(6) The label shall not be used with
an altered label or incorporated into
other label designs.
(7) The label shall not be used on
business cards, company letterhead, or
company stationery.
(8) The label shall not be used in, or
as part of, any company name, logo,
product name, service, or Web site,
except as may be provided for in this
part.
(9) The label shall not be used in a
manner that violates any of the
applicable requirements contained in
this part.
(d) Imported products. The label can
be used only with a product that is
certified by USDA under this part. The
label cannot be used to imply that a
product meets or exceeds the
requirements of biobased programs in
other countries. Products imported for
sale in the U.S. must adhere to the same
guidelines as U.S.-sourced biobased
products. Any product sold in the U.S.
as a ‘‘USDA Certified Biobased Product’’
must have received certification from
USDA.
(e) Contents of the label. The label
shall consist of the items specified in
paragraphs (e)(1) through (3) of this
section, as applicable.
(1) The label artwork provided by the
BioPreferred Program.
(2) The biobased content and
applicable biobased product
statement(s), as specified in paragraph
(f)(2) of this section.
(3) The USDA BioPreferred Web site
address must also be included on, or in
close proximity to, the label.
(f) Physical aspects of the label.
(1) Label artwork. The label artwork
may not be altered, cut, separated into
components, or distorted in appearance
or perspective. Labels that are applied to
biobased products that have been
designated for preferred procurement
will include the letters ‘‘FP’’ as part of
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the label artwork. The label must appear
only in the colors specified in
paragraphs (f)(1)(i) through (iii) of this
section, unless approval is given by
USDA for an exception.
(i) The three-color version of the label
is preferred. The colors used must be
Pantone-White, Pantone 356C, and
Pantone 362C.
(ii) A one-color version of the label
may be substituted for the three-color
version as long as one of the following
colors is used: Pantone 356C or Pantone
362C.
(iii) A black and white version of the
label is acceptable.
(2) Biobased content and applicable
biobased product statement(s). The
biobased content and applicable
biobased product statement(s) must be
placed directly below the label artwork
and must be displayed in a manner that
makes it easily readable.
(i) One or both of the following two
statements, as applicable, must be used
to identify the product to which the
label applies:
(A) Product: XX% biobased.
(B) Packaging: XX% biobased.
(ii) The biobased content reported in
the biobased product statement(s)
specified in paragraphs (f)(2)(i)(A) and
(B) of this section shall be expressed as
‘‘XX%,’’ where XX% represents the
actual biobased content of the product
or packaging. The biobased content
displayed at the time the label is affixed
to the product or its packaging must be
the same as the biobased content
specified in the most recent approved
application for the certified biobased
product.
(3) The USDA BioPreferred Web site
address must be included either on the
label, below the product statement, if
space allows or in close proximity to the
label on the product or packaging.
(g) Placement of the label.
(1) The label can appear directly on a
product, its associated packaging, in
user manuals, and in other materials
including, but not limited to,
advertisements, catalogs, procurement
databases, and promotional and
educational materials.
(2) The label shall not be placed in a
manner that is ambiguous about which
product is a certified biobased product
or that could indicate certification of a
non-certified product.
(3) When used to distinguish a
certified biobased product in material
including, but not limited to,
advertisements, catalogs, procurement
databases, Web sites, and promotional
and educational materials, the label
must appear near a picture of the
product or the text describing it.
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(i) If all products on a page are
certified biobased products, the label
may be placed anywhere on the page.
(ii) If a page contains a mix of
certified biobased products and noncertified products, the label shall be
placed in close proximity to the
certified biobased products. An
individual label near each certified
biobased product may be necessary to
avoid confusion.
(h) Minimum size and clear space
recommendations for the label.
(1) The label may be sized to fit the
individual application as long as the
correct proportions are maintained and
the label remains legible.
(2) A border of clear space must
surround the label and must be of
sufficient width to offset it from
surrounding images and text and to
avoid confusion. If the label’s color is
similar to the background color, an
outlining color may be used to enhance
contrast.
(i) Where to obtain copies of the label
artwork. The label artwork is available
at the USDA BioPreferred Web site.
§ 2904.8
Violations.
This section identifies the types of
actions that USDA considers violations
under this part and the penalties (e.g.,
the suspension or revocation of
certification) associated with such
violations.
(a) General. Violations under this
section occur on a per product basis and
the penalties are to be applied on a per
product basis. Entities cited for a
violation under this section may appeal
using the provisions in § 2904.6. If
certification for a product is revoked,
the manufacturer or vendor whose
certification has been revoked may seek
re-certification for the product using the
procedures specified under the
provisions in § 2904.5.
(b) Types of violations. Actions that
will be considered violations of this part
include, but are not limited to, the
following specific examples:
(1) Biobased content violations. The
Program Manager will utilize occasional
random testing of certified biobased
products to compare the biobased
content of the tested product with the
product’s applicable minimum biobased
content and the biobased content
reported by the manufacturer or vendor
in its approved application. Such testing
will be conducted using ASTM Method
D6866. USDA will provide a copy of the
results of its testing to the applicable
manufacturer or vendor.
(i) If USDA testing shows that the
biobased content of a certified biobased
product is less than its applicable
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minimum biobased content, then a
violation of this part will have occurred.
(ii) If USDA testing shows that the
biobased content is less than that
reported by the manufacturer or vendor
in its approved application, but is still
equal to or greater than its applicable
minimum biobased content(s), USDA
will provide written notification to the
manufacturer or vendor. The
manufacturer or vendor must submit,
within 30 days from receipt of USDA
written notification, a new application
for the lower biobased content. Failure
to submit a new application within 30
days will be considered a violation of
this part.
(A) The manufacturer or vendor can
submit in the new application the
biobased content reported to it by USDA
in the written notification.
(B) Alternatively, the manufacturer or
vendor may elect to retest the product
in question and submit the results of the
retest in the new application. If the
manufacturer or vendor elects to retest
the product, it must test a sample of the
current product.
(2) Label violations.
(i) Any usage or display of the label
that does not conform to the
requirements specified in § 2904.7.
(ii) Affixing the label to any product
prior to issuance of a notice of
certification from USDA.
(iii) Affixing the label to a certified
biobased product during periods when
certification has been suspended or
revoked.
(3) Application violations. Knowingly
providing false or misleading
information in any application for
certification of a biobased product
constitutes a violation of this part.
(4) USDA BioPreferred Web site
violations. Failure to provide to USDA
updated information when the
information for a certified biobased
product becomes outdated or when new
information for a certified biobased
product becomes available constitutes a
violation of this part.
(c) Notice of violations and associated
actions. USDA will provide the
applicable manufacturer or vendor or
their designated representatives and any
involved other entity known to USDA
written notification of any violations
identified by USDA. Entities who
receive a notice of violation for a
biobased content violation must correct
the violation(s) within 30 days from
receipt of the notice of violation.
Entities who receive a notice of
violation for other types of violations
must correct the violation(s) within 60
days from receipt of the notice of
violation. If the entity receiving a notice
of violation is a manufacturer, a vendor,
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or a designated representative of a
manufacturer or vendor, USDA will
pursue notices of suspensions and
revocation, as discussed in paragraphs
(c)(1) and (c)(2) of this section. USDA
reserves the right to further pursue
action against these entities as provided
for in paragraph (c)(3) of this section. If
the entity receiving a notice of violation
is an ‘‘other entity’’ (i.e., not a
manufacturer, vendor, or designated
representative), then USDA will pursue
action according to paragraph (c)(3) of
this section. Entities that receive notices
of suspension or revocation may appeal
such notices using the procedures
specified in § 2904.6.
(1) Suspension.
(i) If a violation is applicable to a
manufacturer, vendor, or designated
representative and the applicable entity
fails to make the required corrections
within 30 days (for biobased content
violations) or 60 days (for other types of
violations) of receipt of a notice of
violation, USDA will notify the
manufacturer or vendor, as appropriate,
of the continuing violation, and the
USDA certification for that product will
be suspended. As of the date that the
manufacturer or vendor receives a
notice of suspension, the manufacturer
or vendor and their designated
representatives must not affix the label
to any of that product, or associated
packaging, not already labeled and must
not distribute any additional products
bearing the label. USDA will issue a
press release informing the public of the
suspension and will also remove the
product information from the USDA
BioPreferred Web site.
(ii) If, within 30 days from receipt of
the notice of suspension, the
manufacturer or vendor whose USDA
product certification has been
suspended makes the required
corrections and notifies USDA that the
corrections have been made, the
manufacturer or vendor and their
designated representatives may, upon
receipt of USDA approval of the
corrections, resume use of the label.
USDA will also restore the product
information to the USDA BioPreferred
Web site.
(2) Revocation.
(i) If a manufacturer or vendor whose
USDA product certification has been
suspended fails to make the required
corrections and notify USDA of the
corrections within 30 days of the date of
the suspension, USDA will notify the
manufacturer or vendor that the
certification for that product is revoked.
(ii) As of the date that the
manufacturer or vendor receives the
notice revoking USDA certification, the
manufacturer or vendor and their
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designated representatives must not
affix the label to any of that product not
already labeled. In addition, the
manufacturer or vendor and their
designated representatives are
prohibited from further sales of product
to which the label is affixed.
(iii) If a manufacturer or vendor
whose product certification has been
revoked wishes to use the label, the
manufacturer or vendor must follow the
procedures required for original
certification.
(3) Other remedies. In addition to the
suspension or revocation of the
certification to use the label, depending
on the nature of the violation, USDA
may pursue suspension or debarment of
the entities involved in accordance with
part 3017 of this title. USDA further
reserves the right to pursue any other
remedies available by law, including
any civil or criminal remedies, against
any entity that violates the provisions of
this part.
§ 2904.9
Recordkeeping requirements.
(a) Records. Manufacturers and
vendors shall maintain records
documenting compliance with this part
for each product that has received
certification to use the label, as
specified in paragraphs (a)(1) through
(3) of this section.
(1) The results of all tests, and any
associated calculations, performed to
determine the biobased content of the
product.
(2) The date the applicant receives
certification from USDA, the dates of
changes in formulation of certified
biobased products, and the dates when
the biobased content of certified
biobased products was tested.
(3) Documentation of analyses
performed by manufacturers to support
claims of environmental or human
health benefits, life cycle cost,
sustainability benefits, and product
performance made by the manufacturer.
(b) Record retention. For each
certified biobased product, records kept
under paragraph (a) of this section must
be maintained for at least three years
beyond the end of the label certification
period (i.e., three years beyond the
period of time when manufacturers and
vendors cease using the label). Records
may be kept in either electronic format
or hard copy format. All records kept in
electronic format must be readily
accessible during a USDA audit.
§ 2904.10
Oversight and monitoring.
(a) General. USDA will conduct
oversight and monitoring of
manufacturers, vendors, designated
representatives, and other entities
involved with the voluntary labeling
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program to ensure compliance with this
part. This oversight will include, but not
be limited to, conducting facility visits
of manufacturers and vendors who have
certified biobased products, and of their
designated representatives.
Manufacturers, vendors, and their
designated representatives are required
to cooperate fully with all USDA audit
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efforts for the enforcement of the
voluntary labeling program.
(b) Biobased content testing. USDA
will conduct biobased content testing of
certified biobased products, as
described in § 2904.8(b)(1) to ensure
compliance with this Part.
(c) Inspection of records.
Manufacturers, vendors, and their
designated representatives must allow
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Federal representatives access to the
records required under § 2904.9 for
inspection and copying during normal
Federal business hours.
Dated: July 17, 2009.
Pearlie S. Reed,
Assistant Secretary for Administration, U.S.
Department of Agriculture.
[FR Doc. E9–17610 Filed 7–30–09; 8:45 am]
BILLING CODE 3410–93–P
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Agencies
[Federal Register Volume 74, Number 146 (Friday, July 31, 2009)]
[Proposed Rules]
[Pages 38296-38317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17610]
[[Page 38295]]
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Part III
Department of Agriculture
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7 CFR Part 2904
Voluntary Labeling Program for Biobased Products; Proposed Rule
Federal Register / Vol. 74 , No. 146 / Friday, July 31, 2009 /
Proposed Rules
[[Page 38296]]
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DEPARTMENT OF AGRICULTURE
7 CFR Part 2904
RIN 0503-AA35
Voluntary Labeling Program for Biobased Products
AGENCY: Departmental Administration, USDA.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The U.S. Department of Agriculture (USDA) is proposing to
establish a voluntary labeling program for biobased products under
section 9002 of the Farm Security and Rural Investment Act of 2002, as
amended by the Food, Conservation, and Energy Act of 2008. Under the
proposed labeling program, a biobased product, after being certified by
USDA, could be marketed using the ``USDA Certified Biobased Product''
label. The presence of the label will mean that the product meets USDA
standards for the amount of biobased content and that the manufacturer
or vendor has provided relevant information on the product for the USDA
BioPreferred Web site. The proposed rule applies to manufacturers and
vendors who wish to participate in the voluntary labeling program. The
proposed rule also applies to other entities (e.g., trade associations)
that wish to use the label to promote biobased products.
DATES: USDA will accept public comments on this proposed rule until
September 29, 2009.
ADDRESSES: You may submit comments by any of the following methods. All
submissions received must include the agency name and Regulatory
Information Number (RIN). The RIN for this rulemaking is 0503-AA35.
Also, please identify submittals as pertaining to the ``Proposed
Voluntary Labeling Program.''
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail/commercial/hand delivery: Mail or deliver your
comments to: Ron Buckhalt, USDA, Office of the Assistant Secretary for
Administration, Room 342, Reporters Building, 300 Seventh Street, SW.,
Washington, DC 20024.
Persons with disabilities who require alternative means
for communication for regulatory information (Braille, large print,
audiotape, etc.) should contact the USDA TARGET Center at (202) 720-
2600 (voice) and (202) 690-0942 (TTY).
You may also send comments on the information collection aspects of
this rule directly to the Office of Information and Regulatory Affairs
of OMB, Attention: Desk Officer for Agriculture, Margaret Malanoski,
725 17th Street, NW., Room 10202, Washington, DC 20503. Comments should
reference OMB control number 0503-NEW.
FOR FURTHER INFORMATION CONTACT: Ron Buckhalt, USDA, Office of the
Assistant Secretary for Administration, Room 342, Reporters Building,
300 Seventh Street, SW., Washington, DC 20024; e-mail:
biopreferred@usda.gov; phone (202) 205-4008. Information regarding the
Federal Procurement Program of Biobased Products (one part of the
BioPreferred Program) is available on the Internet at https://www.biopreferred.gov.
SUPPLEMENTARY INFORMATION: The information presented in this preamble
is organized as follows:
I. Background
A. Authority
B. Overview of Section 9002
II. Purposes of the Voluntary Labeling Program
III. Voluntary Labeling Program
A. Applicability
B. Criteria for Obtaining Certification
C. Initial Approval Process
D. Appeals
E. Information Posted on Web Site
F. Applications for Reformulated Products
G. Requirements Associated With the Label
H. Violations
I. Recordkeeping Requirements
J. Reporting
IV. Suggested Comment Topics
V. Regulatory Information
A. Executive Order 12866: Regulatory Planning and Review
B. Regulatory Flexibility Act (RFA)
C. Executive Order 12630: Governmental Actions and Interference
With Constitutionally Protected Property Rights
D. Executive Order 13132: Federalism
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12372: Intergovernmental Review of Federal
Programs
G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
H. Paperwork Reduction Act
I. Government Paperwork Elimination Act Compliance
J. Small Business Regulatory Enforcement Fairness Act
I. Background
A. Authority
The voluntary labeling program for biobased products is proposed
under the authority of section 9002 of the Farm Security and Rural
Investment Act of 2002 (FSRIA)(referred to in this preamble as
``section 9002''), as amended by the Food, Conservation, and Energy Act
of 2008 (FCEA), 7 U.S.C. 8102.
B. Overview of Section 9002
Section 9002 establishes a program for the Federal procurement of
biobased products by Federal agencies and a voluntary program for the
labeling of biobased products. These two programs, which are referred
to collectively by USDA as the BioPreferred\SM\ Program, are briefly
discussed below.
Federal Procurement of Biobased Products. Section 9002 requires
Federal agencies to develop procurement programs that give preference
to the purchase of biobased products (hereafter referred to in this
Federal Register notice as the ``preferred procurement program'').
Federal agencies and their contractors are required to purchase
biobased products, as defined in regulations implementing the statute,
that are within designated items \1\ when the cumulative purchase price
of the procurement item(s) procured is more than $10,000 or when the
quantities of functionally equivalent items purchased over the
preceding fiscal year equaled $10,000 or more. Each Federal agency and
contractor must procure biobased products at the highest content levels
within each designated item unless the agency determines that the items
are not reasonably available, fail to meet applicable performance
standards, or are available only at an unreasonable price.
---------------------------------------------------------------------------
\1\ The term ``designated item'' refers to items (generic
groupings of specific products that perform the same function) that
have been afforded preferred procurement by Federal agencies under
the BioPreferred Program.
---------------------------------------------------------------------------
The final guidelines for the preferred procurement program were
published in the Federal Register on January 11, 2005 (70 FR 1792). The
guidelines are contained in 7 CFR part 2902, ``Guidelines for
Designating Biobased Products for Federal Procurement.''
Part 2902 is divided into two subparts, ``Subpart A--General,'' and
``Subpart B--Designated Items.'' Subpart A addresses the purpose and
scope of the guidelines and their applicability, provides guidance on
product availability and procurement, defines terms used in part 2902,
and addresses affirmative procurement programs and USDA funding for
testing. Subpart B identifies designated items and specifies their
minimum biobased contents, the effective date of the procurement
preference for biobased products within each designated item, and other
information (e.g., biodegradability). USDA is responsible for
designating biobased items at the highest practicable biobased content
levels for the Federal agencies' preferred procurement programs.
[[Page 38297]]
As part of the preferred procurement program, section 9002 also
requires USDA to provide information to Federal agencies on the
availability, relative price, performance, and environmental and public
health benefits of products within such items and, as applicable under
section 9002(e)(1)(C), to recommend the minimum level of biobased
content to be contained in the products within a designated item.
To date, USDA has designated 33 items used in a variety of
applications, including cafeteria ware, personal and institutional
cleaning products, construction products, and lubricants and greases.
Voluntary Labeling Program. Section 9002 also requires USDA to
establish a voluntary labeling program under which USDA authorizes
manufacturers and vendors of biobased products to use a ``USDA
Certified Biobased Product'' label (hereafter referred to in this
preamble as ``the label''). The voluntary labeling program is intended
to encourage the purchase and use of biobased products by reaching
beyond the Federal purchasing community and promoting the purchase of
biobased products by the general public. In establishing this program,
USDA must identify the criteria to determine those products on which
the label may be used and must develop specific requirements for how
the label can be used. It is USDA's intent that the presence of the
label on a product will mean that the labeled product is one for which
credible factual information is available as to the biobased content,
consistently measured across labeled products by use of the ASTM
radioisotope test D6866.
In developing the proposed voluntary labeling program, USDA held
discussions with other agencies that have implemented labeling
programs, such as the ``ENERGY STAR[supreg]'' program implemented by
the U.S. Department of Energy and the U.S. Environmental Protection
Agency (EPA). USDA has also consulted with representatives of the
Department of Agriculture's National Organic program and others of the
Agricultural Marketing Service. Further, USDA consulted the Federal
Trade Commission, which issues the ``Guides for the Use of
Environmental Marketing Claims'' to ensure that the provisions of the
proposed voluntary labeling program were consistent with the Guides.
USDA also held a public meeting on July 22, 2008, to seek input on the
content and use of the label from the public and industry stakeholders.
The following section of the preamble presents the goal of the
voluntary labeling program and the objectives toward achieving that
goal. That section is followed by a summary of the voluntary labeling
program that USDA is proposing to implement under section 9002(h).
II. Goal of the Voluntary Labeling Program
USDA's goal in proposing this voluntary labeling program is to
encourage the increased use of biobased products in all market sectors.
To achieve this goal, USDA has identified the following objectives:
Promotion of biobased products. The voluntary labeling program is
intended to promote and increase the use of biobased products. In
general, the labeling program supports this goal by recognizing
manufacturers and vendors that produce and market products that utilize
biobased materials and by encouraging consumers to purchase such
products.
Whereas the preferred procurement program is specific to Federal
agencies, the voluntary labeling program is intended to encompass all
individuals and organizations making purchasing decisions. We are
proposing that there be two slightly different versions of the label,
one for those biobased products that have been designated for Federal
preferred procurement because they are within a designated item, and
another for those products that are not within a designated item. The
label artwork for products within designated items would include the
letters ``FP'' to indicate that they are Federally preferred. USDA
believes that informing consumers that these products have been
designated for Federal preferred procurement will be beneficial. As
part of the process of designating items for preferred procurement,
USDA gathers and evaluates information regarding the biobased product's
life cycle costs and environmental performance as well as functional
performance. Thus, the ``FP'' on the label will inform consumers that
USDA has evaluated representative products within the designated item
and found them to be qualified for the Federal preferred procurement
program. USDA also notes that the identification of products that have
been designated for preferred procurement would also be accomplished by
listing those products on the USDA Web site and in Federal procurement
catalogues.
Furthermore, the voluntary labeling program will increase the
amount of information available to manufacturers whose products may
utilize biobased materials or products as a component of their finished
products or as part of their manufacturing process. USDA expects that
this increased information will encourage these manufacturers to
consider using and/or increasing the amount of biobased materials when
designing or manufacturing their products, thereby further increasing
the purchase of biobased materials. For example, manufacturers of
equipment that uses hydraulic fluids are encouraged to consider the use
of biobased hydraulic fluids if available information indicates that
the performance of these fluids meets or exceeds their requirements.
Increase public awareness of biobased products. The voluntary
labeling program will raise the visibility of biobased products within
the Federal government and within the commercial marketplace. The
labeling program will also provide a unique and identifiable designator
recognized in the U.S. and foreign markets.
To the extent that the voluntary labeling program achieves these
objectives, there may be an increased purchase of biobased products,
which is then expected to reduce petroleum consumption, increase the
use of renewable resources, better manage the carbon cycle, and, may
contribute to reducing adverse environmental and health impacts. The
program is also expected to promote economic development for biobased
product manufacturers and vendors by creating new jobs and providing
new markets for farm commodities.
III. Voluntary Labeling Program
In developing the voluntary labeling program, USDA has one primary
goal--to encourage the purchase of biobased products. In implementing
this goal, USDA aims to ensure that only biobased products that meet
the criteria set forth in the voluntary labeling program are labeled
with the ``USDA Certified Biobased Product'' label and that the label
is used properly. USDA believes that products carrying the label will
become readily recognizable as biobased products, distinct from those
that do not carry the label. Further, as the label will have the
percent of biobased material printed on it, consumers will recognize
that products carrying the label meet certain criteria that set them
apart from other products.
A. Applicability
The proposed rule would apply to manufacturers and vendors of
biobased products, as well as to other entities (e.g., trade
associations, public interest groups) that promote, sell, or use the
products. USDA believes that each of these groups must comply with the
labeling requirements in order to ensure that only certified biobased
products
[[Page 38298]]
(i.e., biobased products that have been approved for use of the label
under this program) carry the label and that the label is used
correctly. USDA believes that the goals of the voluntary labeling
program can be achieved, and the beneficial impacts of the BioPreferred
program can be increased, if manufacturers, vendors, and other entities
are allowed to market and promote the manufacturers' biobased products
with a credible biobased products labeling program.
Once USDA has approved a biobased product for labeling by its
manufacturer or vendor, an equally important aspect in ensuring the
integrity of the labeling program is the proper use of the label. Label
misuse can occur at the manufacturer level (e.g., affixing the label to
a non-certified biobased product) and at the retail level (e.g., using
the label to imply that a non-certified biobased product has been
certified), or by other entities wishing to use the label in promoting
the sales or public awareness of non-certified biobased products (e.g.,
on a Web site or in promotional materials).
While the labeling of biobased products is voluntary,
manufacturers, vendors, and other entities wishing to use the label in
their marketing, promotional, or educational efforts would be required
to comply with regulatory requirements as proposed herein. USDA
believes these requirements for use of the label are necessary to avoid
misleading consumers regarding whether a product has been certified by
USDA under the voluntary labeling program.
B. Criteria for Obtaining Certification
To be eligible for USDA certification to use the label, USDA
proposes that a product meet two criteria, as discussed below.
Criterion 1: Biobased Product. The product must be a biobased
product. Biobased product is defined in section 2904.2 of today's
proposed rule as follows: ``The term `biobased product' means a product
determined by the Secretary to be a commercial or industrial product
(other than food or feed) that is--(A) composed, in whole or in
significant part, of biological products, including renewable domestic
agricultural materials and forestry materials; or (B) an intermediate
ingredient or feedstock. For the purposes of this subpart, the term
`biobased product' does not include motor vehicle fuels, heating oil,
electricity produced from biomass, or any mature market products.
Products from a mature market will be determined on a case-by-case
basis.''
Rationale for Criterion 1: As discussed earlier, section 9002
requires USDA to establish a voluntary labeling program under which
USDA authorizes manufacturers and vendors of biobased products to use a
``USDA Certified Biobased Product'' label. USDA is proposing that
mature market products not be eligible to use the label except on a
case-by-case basis. Mature market products are those biobased products
that had significant national market penetration in 1972. Examples of
mature market products include cotton shirts or towels, paper plates,
and wood furniture. USDA has excluded mature market products from the
Federal preferred procurement program. In USDA's explanation for
excluding mature market products from the preferred procurement
program, USDA stated in the preamble to the final Guidelines (70 FR
1802), ``The intent of section 9002, as described in the conference
report accompanying FSRIA, `is to stimulate the production of new
biobased products and to energize emerging markets for those products.'
''
Based on conference report, it is clear that Congress did not
intend for mature market products to be given Federal procurement
preference. It is not clear, however, whether this exclusion of mature
market products was intended to apply to the voluntary labeling
program. The procurement preference program and the labeling program
are contained in different paragraphs of the statute, and the
conference report does not specifically state whether the language
quoted above refers to just one or to both paragraphs.
USDA believes, however, that the widespread labeling of mature
market products could negatively impact the entry of new biobased
products into market segments in which mature products already have
significant market shares. Thus, USDA believes that it is reasonable to
exclude many mature market products from the labeling program, as it
has done for the preferred procurement program. USDA is, however,
proposing to allow manufacturers of mature market products to appeal
(on a case-by-case basis) the exclusion of their products from the
program.
Criterion 2: Minimum Biobased Content. For a biobased product to
receive certification under this proposed rule, the biobased content of
that product must be at or above its applicable minimum biobased
content, as described below. USDA believes this requirement is
necessary so that the label is not used to promote products with de
minimis biobased content. As discussed below, the applicable minimum
biobased content depends under which of the three proposed categories
the product falls.
1. Biobased products within one or more designated items. If a
biobased product (including an intermediate ingredient or feedstock) is
within a designated item at the time of submitting an application for
certification, the applicable minimum biobased content for use of the
label would be the minimum biobased content specified for that item in
7 CFR 2902. As discussed in more detail below, once an item has been
designated, its minimum biobased content, as specified in 7 CFR part
2902, becomes the applicable minimum biobased content for all products
within that designated item, regardless of any previous minimum
biobased content used to qualify a product for using the label.
If a biobased product is marketed within more than one designated
item, and uses the same packaging, its biobased content must meet or
exceed the specified minimum biobased content for each of the
designated items in order to use the label for each item. For example,
Product A is currently marketed as a ``glass cleaner'' and a ``bath and
tile cleaner'' and uses the same packaging in both markets. USDA has
designated both these categories of products as items under its
BioPreferred procurement program. Product A has a biobased content of
60 percent. The minimum biobased content of designated item ``glass
cleaners'' is 49 percent and the minimum biobased content of designated
item ``bath and tile cleaners'' is 74 percent. The manufacturer would
not be eligible to apply for use of the label for Product A under
either designated item. If the biobased content of Product A were
instead 80 percent, the manufacturer would be eligible to use the label
under both designated items.
If, on the other hand, the manufacturer packaged the product in
different packaging for marketing within the two designated items
(e.g., a blue bottle for the glass cleaner and a green bottle for the
bath and tile cleaner), the product marketed as a glass cleaner would
be eligible to apply to use the label while the product marketed as
bath and tile cleaner would not be eligible.
2. Finished biobased products that are not within designated items.
If a biobased product is not within a designated item at the time the
application for certification is submitted, the applicable minimum
biobased content for the product for using the label would be 51
percent,
[[Page 38299]]
unless USDA approves an alternative applicable minimum biobased
content. The proposed rule would allow manufacturers, vendors, and
trade associations (individually or collectively) who believe that the
51 percent minimum biobased content is not appropriate for the biobased
product to conduct an analysis, as discussed under ``Alternative
Minimum Biobased Content Analysis'' later in this preamble, to support
an alternative applicable minimum biobased content. If USDA approves
the alternative applicable minimum biobased content, then that content
becomes the applicable minimum biobased content for that product.
USDA recognizes that there will be groups of biobased products that
will be certified to use the label that will never be designated for
preferred procurement, primarily because these products are produced by
only one manufacturer and, thus, there is not sufficient market
competition to justify preferred procurement or they are not used
prevalently in the Federal marketplace. However, USDA expects that the
majority of the biobased products certified to use the label will be
within a group of products that USDA designates for preferred
procurement. In those cases where USDA subsequently designates an item
under which the certified biobased product falls for inclusion in the
preferred procurement program, the applicable minimum biobased content
for the product will then become the minimum biobased content
established for the designated item under which the product falls. As
of the effective date of the designation, only those products that meet
the new minimum biobased content may continue to use the label.
3. Products that are intermediate ingredients or feedstocks that
are not within designated items. If a biobased product is an
intermediate ingredient or feedstock and is not within a designated
item at the time the application for certification is submitted, the
applicable minimum biobased content for the product for using the label
would be 51 percent, unless USDA approves an alternative applicable
minimum biobased content. As with the previous product category, the
proposed rule would allow manufacturers, vendors, and trade
associations (individually or collectively) who believe that the 51
percent minimum biobased content is not appropriate to conduct an
analysis, as discussed under ``Alternative Minimum Biobased Content
Analysis'' later in this preamble, to support an alternative applicable
minimum biobased content. If USDA approves the alternative applicable
minimum biobased content, then that content becomes the applicable
minimum biobased content for that product.
Rationale for Criterion 2: USDA believes setting the applicable
minimum biobased content of products within designated items at the
minimum biobased content specified under the preferred procurement
program is appropriate, as USDA has had an opportunity to perform an
analysis on these products, including identifying similar biobased
products and their manufacturers, and obtaining biobased contents for
similar biobased products. USDA intends to proceed with the designation
of numerous items for which it has, or is currently gathering,
information. Once the designation process has been completed for those
items that have been identified for designation, USDA intends to
revisit, on a periodic basis, the minimum biobased content that was
established for designated items at the time of their designation. As
scientific advances and economic conditions warrant, USDA would expect
that the applicable minimum biobased content for designated items will
rise as competitors apply advances and increase the biobased content of
designated products. Thus, it is USDA's expectation that the applicable
minimum biobased content of designated items will increase as
advancements are made in biobased product technology. USDA also notes
that proposed revisions to the applicable minimum biobased content for
designated items will be announced in the Federal Register and the
public will have an opportunity to provide comments on the proposal.
For the second and third categories of products (finished biobased
products and intermediate ingredients and feedstocks that are not
within designated items) USDA considered several options for setting
the minimum biobased content, including the use of the lowest minimum
biobased content for any item designated to date. USDA decided,
however, that in the absence of the level of detailed product
information for setting a minimum biobased content based on product-
specific data (as is used under the preferred procurement program), and
in an effort to discourage minimal use of biobased feedstocks in what
are otherwise not biobased products, it is reasonable to consider such
finished products as ``biobased'' if they contain a significant amount
of biobased materials; that is, at least 51 percent of the product is
biobased. Thus, USDA is proposing that all finished products that are
not within designated items and all intermediate ingredients and
feedstocks that are not within designated items must contain at least
51 percent biobased content to be qualified for the label.
USDA recognizes, however, that for some finished products (and
intermediate ingredients) a 51 percent minimum biobased content may
result in a product that is not viable. USDA also recognizes that the
51 percent minimum biobased content could discourage the development of
new biobased products or the continued development of existing biobased
products. With this in mind, USDA will continue to gather product-
specific data under the preferred procurement program to determine
applicable minimum biobased contents. Additionally, USDA believes that
it is reasonable to provide a procedure to allow manufacturers,
vendors, and trade associations to propose an alternative applicable
minimum biobased content for such products.
Alternative Minimum Biobased Content Analysis
As noted above, manufacturers, vendors, and trade associations
would be allowed to propose an alternative minimum biobased content for
products not within a designated item if they believe that the proposed
minimum biobased content is not appropriate for their product(s). For
USDA to consider an alternative minimum biobased content for these
types of products, manufacturers, vendors, and trade associations would
be required to develop an analysis, in consultation with USDA, that
demonstrates the need for an alternative applicable minimum biobased
content. USDA believes that manufacturers, vendors, and trade
associations should consult with the Department in developing the
analysis to help ensure that an appropriate analysis is conducted.
While the analysis of the data supporting a specific request for an
alternative minimum biobased content will be performed on a case-by-
case basis, USDA anticipates that the evaluation process will be
standardized and will be similar to the process used to set minimum
biobased contents under the preferred procurement program. Such a
process would include identifying similar biobased products and their
manufacturers and determining biobased contents for similar biobased
products. USDA recognizes the difficulties involved in collecting
biobased contents, due in large part to the unpredictability of
manufacturer and vendor participation
[[Page 38300]]
in providing products for testing. Similar to the process used in the
preferred procurement program, the establishment of alternative minimum
contents for the labeling program will require a measure of flexibility
to address the variability in product type and level of industry
development. In general, the number of samples that should be obtained
for the biobased content analysis would depend on the number of
manufacturers of a product and similar products available. USDA would
expect applicants to coordinate with program officials to identify and
agree upon a reasonable number of samples for the analysis. Emphasis
would be focused on obtaining the maximum number of samples possible
without restricting the analysis process.
C. Initial Approval Process
Application
Manufacturers and vendors seeking use of the label on a qualified
biobased product must submit to USDA a separate USDA-approved
application for certification for each product for which the
manufacturer or vendor wishes to receive USDA approval to use the
label. Both the application and instructions for submittal of the
application will be available on the USDA BioPreferred Web site.
Each application must contain both contact and product information.
Contact information would include the applicant's name, mailing
address, e-mail address, and telephone number, and the name, mailing
address, telephone number, and e-mail address (if available) of the
person who prepared the application.
Product information would include the brand names or other product
identifying information (such as model name or number, or UPC number)
for the product, the biobased content of the product for which
certification is sought, contact information on the third-party testing
entity that tested the biobased content and documentation that the
testing entity is ISO 9001 conformant, the product category under which
the product falls, and the intended uses of the product. If the product
falls within a designated item(s), the applicant would also identify
the name of the designated item(s).
Lastly, the applicant would be required to sign a statement that
certifies that the product identified in the application is a biobased
product as defined in the labeling program and commits the applicant to
provide to USDA, and to keep up-to-date, the product's brand name(s),
or other identifying information; contact information, including the
name, mailing address, e-mail address, and telephone number of the
applicant; the biobased content of the product; and a hot link directly
to the applicant's Web site (if available). USDA is also requiring that
if manufacturers make claims on the product packaging about the
environmental and human health effects, life-cycle costs,
sustainability benefits, and performance of their products that
documentation supporting such claims be maintained.
Justification for Required Information
USDA considers the information required for the initial approval
process to be the minimum that will be needed by USDA to confirm that
products meet the criteria for certification. The following paragraphs
summarize the rationale for requiring the information specified.
Contact Information. This information is necessary for
communicating with the applicant concerning any issues with the
application, whether the application is deficient, and whether the
application has been approved.
Brand Names. Because a manufacturer or vendor may market the same
product under different brand names (or other product identifiers such
as model names or numbers), the application requires that all brand
names or other applicable product identifiers for that product be
provided. This will prevent the necessity of multiple applications from
the same manufacturer or vendor for the same product.
Biobased Content Information. For products in the three categories
discussed earlier, the biobased content of the product for which
certification is sought would be determined by ISO 9001 certified or
conformant,\2\ third-party testing firms using ASTM Method D6866,
``Standard Test Methods for Determining the Biobased Content of Natural
Range Materials Using Radiocarbon and Isotope Ratio Mass Spectrometry
Analysis.''
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\2\ ISO 9001 conformant means that the entity meets the
requirements of ISO 9001, but is not required to be ISO 9001
certified.
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In the case of a product that is marketed under different brand
names, the proposed rule would allow the manufacturer or vendor to test
the product once rather than requiring brand-name specific data,
thereby minimizing unnecessary testing of the same product that is
simply marketed under different brand names.
The applicant is required to provide the product's biobased
content, as determined using ASTM Method D6866, and contact information
on the entity that performed the testing. The applicant is also
required to provide documentation that the third-party testing entity
that determined the biobased content reported for the product is ISO
9001 conformant. This information is necessary to demonstrate that the
product's biobased content meets or exceeds the applicable minimum
biobased content and that a qualified, independent, third-party testing
entity conducted the testing.
Product Category. The applicant is required to identify whether the
product (1) falls within one or more designated items under the
preferred procurement program (and if so, the applicant is required to
identify the item(s)), (2) is a finished biobased product that is not
within a designated item, or (3) is an intermediate ingredient or
feedstock that is not within a designated item. This information is
necessary to identify the applicable minimum biobased content and then
to ensure that the biobased content of the product meets or exceeds the
applicable minimum biobased content.
Intended use(s). The applicant is required to provide a description
of the intended uses of the product (e.g., as a glass cleaner or as a
penetrating lubricant). USDA will use this description to confirm that
the product is assigned to the appropriate designated item(s), if
applicable. This will also allow USDA to determine if a product should
have been assigned to a designated item, if the application incorrectly
indicates that the product falls outside the designated item category.
Certifications and statements. The applicant must certify that the
product for which certification is sought is a biobased product, as
defined by the labeling program. USDA is proposing that applicants
certify to this criterion and keep appropriate records to demonstrate
that the product complies with this certifying statement, which USDA
can then review during an audit. This condition must be met in order to
ensure compliance with statutory requirements under which the voluntary
labeling program is being established.
As noted earlier in this preamble, the applicant is also required
to commit to providing to USDA information, and keeping it up-to-date,
for posting by USDA on the BioPreferred Web site. This information
includes the product's brand name(s) or other product identifiers;
contact information, including the name, mailing address, e-mail
address, and telephone number of the applicant; biobased content; and a
[[Page 38301]]
hot link directly to the applicant's Web site (if available).
While USDA is not requiring manufacturers to analyze the
environmental and human health effects, life-cycle costs,
sustainability benefits, and performance of their products,
manufacturers making claims regarding these attributes of their
products must maintain documentation to substantiate those claims
pursuant to the Federal Trade Commission (FTC) Act. Section 5 of the
FTC Act (15 U.S.C. 45) makes unlawful deceptive acts and practices in
or affecting commerce. The FTC ``Guides for the Use of Environmental
Marketing Claims'' (16 CFR part 260) state that ``any party making an
express or implied claim that presents an objective assertion about the
environmental attribute of a product, package or service must, at the
time the claim is made, possess and rely upon a reasonable basis
substantiating the claim.''
Evaluation
USDA will evaluate each application to determine if it is a
``complete'' application (i.e., that it contains all of the required
information). If USDA determines that the application is not complete,
it will return the application to the applicant and provide an
explanation of the deficiencies in the application. Once the
deficiencies have been addressed, the applicant may resubmit the
application for review by USDA.
USDA will evaluate each complete application to determine if the
product meets the criteria for certification discussed above (and
specified in Sec. 2904.4). There will be no specified deadline for
application submissions; applications will be worked on in a first come
first serve basis. Based on this evaluation, USDA either will
conditionally approve the application or will disapprove the
application. USDA will provide to each applicant a written response
within 60 days after the receipt of a complete application, informing
the applicant whether or not its application has been conditionally
approved or has been disapproved. An applicant who receives notice from
USDA that its application has been conditionally approved may not begin
using the label on its product until the applicant receives a notice of
certification from USDA (see next paragraph). For those applications
that are not approved, USDA will notify the applicant and identify each
criterion not met. Applicants whose applications are not approved have
the right to appeal under the proposed program first to USDA's
BioPreferred program office and then to USDA policy officials.
Notice of Product Certification
After an applicant receives notice from USDA that its application
(for the product to bear the label) has been conditionally approved,
the applicant must provide certain information, as discussed in Section
E in this preamble, to USDA. Once USDA has confirmed that the
information supplied by the applicant is complete, USDA will approve
the product label application and will issue a notice of product
certification to the applicant. USDA will include in the notice of
certification information necessary for the applicant to access the
applicable label artwork from the USDA BioPreferred Web site. Upon
receipt of the notice of certification, the applicant may begin using
the label on the certified biobased product.
Term of Product Certification
The effective (beginning) date of the product certification is the
date that the applicant receives the notice of certification from USDA.
The certification will remain valid for as long as the biobased product
is manufactured in accordance with the information supplied in the
approved application and presented on the USDA Web site, with one
exception. As discussed earlier, it is USDA's intent that the
applicable minimum biobased content of designated items will increase
over time as advancements are made in biobased product technology. If
the applicable required minimum biobased content for a product to be
eligible to display the label is revised by USDA, manufacturers and
vendors may continue to label their previously certified product only
if it meets the new minimum biobased content level. In those cases
where the biobased content of a certified product fails to meet the new
minimum biobased content level, USDA will notify the manufacturer or
vendor that their certification is no longer valid. Such manufacturers
and vendors must increase the biobased content of their product to a
level at or above the new minimum biobased content level and must re-
apply for certification within 60 days of receiving USDA's notice if
they wish to continue to use the label. Manufacturers and vendors who
have re-applied for certification may continue using the existing label
until they receive notification from USDA on the results of their re-
application for certification.
USDA considered proposing a certification period of either three or
five years, but decided that a fixed certification period was
unnecessary and that the process of reapplying every three or five
years would impose an undue burden on manufacturers who did not
reformulate their products. In the case of items that become
designated, it is likely that the required minimum biobased content for
the item could be different from the 51 percent level used to qualify
the item before it was designated. USDA believes that, in those cases,
only those products that meet the new minimum biobased content should
be eligible to display the label. Thus, USDA is proposing that if a
certified product's biobased content is below the newly established
minimum biobased content, the manufacturer must discontinue applying
the label as of the effective date of the item designation. The same
would be true in any other case where USDA, through established notice
and comment rulemaking procedures, revises the minimum biobased content
applicable to a previously certified product.
USDA points out that affixing the label to a certified biobased
product does not imply that the useful life or the shelf life of the
product has been affected in any way. Purchasers of labeled certified
biobased products, therefore, should continue to look to information
from the manufacturer or vendor to ascertain whether a product will
perform as advertised at the time the purchase is made.
D. Appeals
Today's proposed rule includes provisions for appeal by an
applicant whose application for certification is denied by USDA. In
addition, entities that have been cited for a violation or that have
received a notice of suspension or a notice of revocation may also file
an appeal. All appeals must be filed within 30 days of receipt of the
applicable notice. Appeals must be made in writing to the Program
Manager of the Voluntary Labeling Program for Biobased Products and
must contain, in part, a statement, including appropriate
substantiating documentation, of the appellant's reasons for believing
that USDA wrongfully denied the application or issued a notice of
violation, suspension, or revocation. If the appellant is dissatisfied
with the results of this appeal, he/she may raise the appeal to the
Assistant Secretary for Administration by letter request. Appeals to
the Assistant Secretary for Administration must be filed within 30 days
of receipt of the notice of decision from the appeal to the Program
Manager.
[[Page 38302]]
The proposed rule also includes provisions for manufacturers or
vendors of mature market products to appeal the exclusion of their
products from the voluntary labeling program if they believe that
conditions justify the use of the label on their products.
E. Information Posted on Web Site
Before USDA issues the notice of certification to a manufacturer or
vendor to use the label on a biobased product, the manufacturer or
vendor must submit contact and product information to USDA, which USDA
will then post on the USDA BioPreferred Web site (which can be accessed
at https://www.biopreferred.gov). This information must be complete and
must be provided to USDA before USDA will provide to the manufacturer
or vendor, the notice of certification and the information for
accessing the label artwork. The information that must be provided to
USDA is:
Product brand name(s) or other identifying information;
Contact information for the applicant;
Biobased content level; and
A hot link directly to the applicant's Web site (if
available).
In addition to the information listed above, USDA encourages
manufacturers to provide other information related to product features
and applicability for posting to the Web site.
USDA believes that making the information identified above
available on the USDA BioPreferred Web site will be an extremely
valuable step in establishing a database of certified biobased
products. Ideally, both Federal agencies and public consumers will be
able to readily access information that will help them in their
decision-making regarding the purchase of biobased products. USDA
believes that making this information available not only to Federal
agencies, but also to public consumers will result in increased
consumer awareness of and use of biobased products. USDA is also
proposing that manufacturers of certified biobased products must
include the USDA Web site address on or in close proximity to the
label.
Manufacturers must provide to USDA updated information for posting
by USDA to the USDA BioPreferred Web site whenever any of the
information on the Web site becomes outdated or if additional relevant
information becomes applicable. As discussed in Section I of this
preamble, failure to provide USDA with updated information will be
considered a violation of the requirements of the labeling program.
F. Applications for Reformulated Products
A manufacturer may decide to change the formulation of a certified
biobased product for various reasons including performance issues, raw
material availability, or changes in production processes. As discussed
earlier, manufacturers may also be required to reformulate products
that are within designated items in response to USDA re-evaluating and
increasing the applicable minimum biobased content for products within
the designated item. For such reformulated products to be eligible for
USDA certification to use the label, USDA proposes that a new
application be submitted to USDA, as discussed below.
If a certified product's biobased content is decreased by any
amount, a new application would be required. In any case where the
biobased content of a product is decreased from the original
formulation, the biobased content of the reformulated product must
still be at or above the applicable minimum biobased content for the
product in order for the product to qualify for the label.
In the case of a product whose biobased content is reduced, the
manufacturer or vendor cannot affix the label to the reformulated
product until they have submitted a new application, provided USDA with
the required information on the reformulated product for posting to the
USDA BioPreferred Web site, and received the notice of certification
for the reformulated product from USDA. If the manufacturer or vendor
also continues to sell the product in its original formulation, the
manufacturer or vendor may continue to affix the label to the original
product.
If a certified product's biobased content is increased, and the
manufacturer wishes to change the label to report the higher value, a
new application would be required. The manufacturer or vendor may
continue to affix the label to the reformulated product. However, the
manufacturer or vendor may not revise the biobased content displayed on
the label until they have submitted a new application, provided USDA
with the required information on the reformulated product for posting
to the USDA BioPreferred Web site, and received the notice of
certification for the reformulated product from USDA.
G. Requirements Associated With the Label
Today's proposed rule establishes specific requirements for the use
of the label. The requirements in today's proposed rule specify who may
use the label, correct and incorrect uses of the label, the physical
appearance of the label, and restrictions on the use of the label.
These requirements are summarized in the remainder of this section.
USDA is also developing a Marketing Guide that will be made
available to manufacturers and vendors of labeled products. The purpose
of this Marketing Guide is to provide expanded discussions of, and
guidance on resolving, implementation issues that may arise related to
the use of the label. For example, USDA anticipates that there will be
questions related to the best way to apply the label on very small
products, such as those within the designated item ``lip care
products.'' USDA believes that a Marketing Guide, that can be updated
frequently, is the most efficient way to keep label users informed of
guidance provided by USDA in response to implementation issues that
arise.
Who May Use the Label?
Any manufacturer or vendor who has received notice of certification
from USDA, and any designated representative of such manufacturers and
vendors, may use the label on the product and its associated packaging
and in the advertising of the certified biobased product. As proposed,
only the manufacturer or vendor (and their designated representatives)
of a certified biobased product would be granted the authority to affix
the label to the product. The process of applying for and receiving
certification requires specific knowledge of the product and its
characteristics and formulation. Obtaining certification also imposes
the requirement on the manufacturer and vendor to provide certain
information to USDA, which USDA will then post on the USDA BioPreferred
Web site.
Other entities may use the label to advertise or promote certified
biobased products (e.g., in catalogs or procurement databases), as long
as the manufacturer or vendor of the product (or one of their
designated representatives) has affixed the label to the product or its
packaging. USDA believes that allowing other entities to use the label
in informational, promotional, and educational materials for certified
biobased products will promote the goal of encouraging the use of
biobased products.
Use of the Label
The label may be affixed only to products (or associated packaging)
for which a manufacturer or vendor has received a notice of
certification under
[[Page 38303]]
this part. USDA's intent is for the label to be used by manufacturers,
vendors, and other entities to distinguish biobased products that meet
or exceed the criteria established by USDA from those that do not meet
the criteria. It is also important that the label be used in a
consistent manner such that the label and its meaning will become
recognizable in the marketplace. Use of the label on non-certified
products or alterations in the appearance of the label may confuse
consumers and diminish the value of not only the label, but also the
entire biobased product program. Therefore, USDA has identified correct
and incorrect uses of the label, which are discussed in the following
paragraphs.
Correct Uses. Proposed section 2904.7 identifies correct usages of
the label. These include, but are not limited to the following:
The label may be used in advertisements, catalogs,
procurement databases, Web sites, and promotional and educational
materials;
The label may appear next to a picture of the product(s)
or text describing the product(s); and
The label may be used without reference to a specific
certified biobased product only when informing the public about the
purpose of the label. For example, the following or similar claim is
acceptable: ``Look for the `USDA Certified Biobased Product' label. It
means the product meets USDA standards for the amount of biobased
content and the manufacturer or vendor has provided relevant
information on the product for the USDA BioPreferred Web site.'' This
exception allows manufacturers, vendors, and other entities to use the
label in documents such as corporate reports, but only in an
informative manner, not as a statement of product certification.
Incorrect Uses. Proposed Sec. 2904.7 also identifies incorrect
usages of the label. These include, but are not limited to the
following:
The label may not be used on non-certified products or in
advertisements or informational materials for non-certified products;
The label may not be used to imply endorsement by USDA or
the BioPreferred Program of any particular product, service, or
company; and
The label may not be used in any form that could be
misleading to the consumer, or on business cards, company letterhead,
or company stationery.
Imported Products
Because other countries may have different definitions of
``biobased'' and/or use other terms, it is necessary to address the use
of the label on products for import. The ``USDA Certified Biobased
Product'' label signifies that a product meets specific USDA criteria
for biobased products. Therefore, in order for products imported for
sale in the U.S. to carry the label, they must meet the same criteria
as U.S.-sourced biobased products, and their manufacturers and vendors
must apply for certification to use the label, even if the products are
considered biobased products in the country in which they are
manufactured.
Contents of the Label
The label must consist of the following:
The logo with the phrase ``USDA Certified Biobased
Product'' and, where applicable, the letters ``FP'' to indicate that
the product is within a Federally preferred designated item (this label
content is collectively referred to as the ``label artwork''); and
A statement that identifies the biobased content of the
product, as reported in the approved application for the product at the
time the label is affixed to the product or its packaging, and whether
the label applies to the product or packaging.
USDA is proposing that the statement that identifies the biobased
content also indicate whether the label applies to the product or the
packaging (e.g., Product: 57% biobased; Packaging: 90% biobased). The
USDA is proposing that this statement be included in the label in order
to make it clear as to what the certified biobased product is. USDA
believes that there will be instances where the placement of the label
on a product or its packaging will not clearly identify the certified
biobased product. For example, it is possible that a label placed on a
container will refer to the container itself (in which case the
statement ``Packaging: XX% biobased'' would be used) or to the contents
within the container (Product: YY% biobased). It may also be possible
that both the container and its contents are certified biobased
products, in which case two statements would appear (Product: YY%
biobased. Packaging: XX% biobased). Without tying the label to the
product or the packaging, the consumer may be unable to determine which
product is the certified biobased product. Therefore, USDA is proposing
that the appropriate statement(s) be included in the label in order to
identify clearly the product or products to which the label applies.
Furthermore, the proposed rule requires that, at the time the label
is affixed to the product or its packaging, the biobased content shown
on the label is the same as the biobased content found in the approved
application for the product. It is possible, however, that the biobased
content of a certified product could be changed by the manufacturer. If
a certified product's biobased content is changed to a level below that
shown on the label, the product is considered a reformulated product
and a new application is required. If a certified product's biobased
content is increased and the manufacturer wishes to change the label to
the higher value, a new application is also required.
USDA also requires manufacturers and vendors to include the USDA
BioPreferred Web site address on or in close proximity to the label.
USDA is not proposing to require that the Web site address be on the
label itself because the label on many products will not be large
enough to accommodate this extra information. USDA believes that, where
practicable, the presence of the USDA BioPreferred Web site address on
the label will assist consumers in obtaining information about biobased
products.
Physical Aspects of the Label
The rule addresses the physical aspects of the label artwork and
the presentation of the biobased product statement. In addition to the
requirements of the rule, USDA anticipates that guidance on specific
issues related to the physical aspects of the label will be provided in
the Marketing Guide.
Label Artwork
To maintain the distinctiveness of the label artwork (which
consists of the logo, the phrase ``USDA Certified Biobased Product''
and, where applicable, the letters ``FP'') and to make sure that it is
readily recognizable, USDA has established requirements related to the
physical appearance of the label artwork. The applicable label artwork
provided by the BioPreferred Program must be used.
USDA is also proposing color requirements to ensure that the label
artwork remains distinctive and recognizable. USDA is proposing to
require that one of three label versions be used, depending on the need
of the product. (1) A three-color version of the label artwork (white
plus two shades of green); (2) a one-color version of the label artwork
as long as the color used is one of the two greens specified in section
2904.7(f) of today's proposed rule; and (3) a black and white version
of the label artwork is also acceptable. The contrast between the light
and dark
[[Page 38304]]
sections of the label artwork should be great enough to maintain the
distinctiveness of the design.
Finally, the label artwork may not be altered, cut, separated into
components, or distorted in appearance or perspective.
Biobased product statement. The applicable biobased product
statement(s), which identifies the product(s) to which the label
applies and the biobased content(s), would be placed below the label
artwork. The biobased content must be expressed as ``XX%,'' where XX%
represents the actual biobased content of the product. The biobased
content must be easily readable. Figure 1 illustrates the placement of
the biobased product statement.
[GRAPHIC] [TIFF OMITTED] TP31JY09.000
Placement of the Label
Whether the label is placed directly on a product, on associated
packaging, in user manuals, or in other material, it should always be
placed in a manner that ensures that the label (label artwork and
biobased product statement(s)) can be readily associated with the
applicable certified biobased product. The label should not be placed
in a manner that is ambiguous about which product is a certified
biobased product or that could indicate certification of a non-
certified product. If all products on a printed page are certified
biobased products, the label may be placed anywhere on the page.
However, if a printed page contains a mix of certified biobased
products and non-certified products, the label must be placed in close
proximity to the certified biobased products. An individual label
located near each certified biobased product may be necessary to avoid
confusion.
Minimum Size and Clear Space Recommendations for the Label
USDA recognizes that a specific size requirement for the label
would not be appropriate because of the variety of sizes and shapes of
products that may be certified. Therefore, the label may be sized to be
appropriate for the particular application as long as the correct
proportions are maintained and the label remains legible.
A border of clear space must surround the label and must be of
sufficient width to offset it from surrounding images and text and to
avoid confusion. If the label's color is similar to the background
color, an outlining color may be used to enhance contrast.
Where To Obtain Copies of the Label Artwork
The two versions of the label artwork (with and without the letters
``FP'', as applicable) will be available at the USDA BioPreferred Web
site. Only manufacturers and vendors approved for use of the label for
certified biobased products will be able to obtain the label from the
Web site. USDA will provide the necessary access (through the notice of
certification) once a manufacturer or vendor has provided USDA with the
required information, which USDA will post to the USDA BioPreferred Web
site, for a product whose application for certification has been
approved by USDA.
H. Violations
Although the decision to participate in the certified biobased
products labeling program is voluntary, compliance with the program
requirements and specifications will be essential to the success of the
program. Proposed section 2904.8 identifies examples of the types of
actions that would be violations of the labeling program.
To enforce the provisions of the voluntary labeling program, USDA
will implement an audit program. This audit program will include, but
not necessarily be limited to, conducting inspections of manufacturer
and vendor facilities, visiting retail facilities, and testing the
biobased content of certified biobased products. Visiting manufacturer
and vendor facilities and inspecting their records, for example, will
help USDA identify potential label and application violations. Testing
certified biobased products for their biobased contents will help USDA
determine any violations associated with biobased contents.
Manufacturers, vendors, and their designated representatives are
required to cooperate fully with all USDA audit efforts for the
enforcement of the voluntary labeling program. USDA envisions selecting
five to ten percent of labeled products at random for audit each year.
Both the violations being proposed and any penalties associated
with a violation would be applied on a per product basis. For example,
a manufacturer has two certified biobased products, Product A and
Product B. The manufacturer has been cited for a labeling violation for
Product A and the certification for Product A has been revoked. As
proposed, the manufacturer would be required to discontinue labeling
Product A, and USDA would remove the information for Product A from the
USDA BioPreferred Web site. If no actions were taken against the
manufacturer with regard to Product B, the manufacturer's certification
for Product B would not be affected by the violation associated with
Product A. Thus, the manufacturer would still be allowed to affix the
label to Product B, and Product B's information would
[[Page 38305]]
remain on the USDA BioPreferred Web site.
Finally, the appeals process described previously is also
applicable when a notice of violation, suspension, or revocation is
issued.
Biobased Co