[Federal Register Volume 76, Number 13 (Thursday, January 20, 2011)]
[Rules and Regulations]
[Pages 3790-3813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-968]



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Part IV





Department of Agriculture





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7 CFR Part 2904



Voluntary Labeling Program for Biobased Products; Final Rule

Federal Register / Vol. 76 , No. 13 / Thursday, January 20, 2011 / 
Rules and Regulations

[[Page 3790]]


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DEPARTMENT OF AGRICULTURE

7 CFR Part 2904

RIN 0503-AA35


Voluntary Labeling Program for Biobased Products

AGENCY: Departmental Management, USDA.

ACTION: Final rule.

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SUMMARY: The U.S. Department of Agriculture (USDA) is establishing 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 voluntary 
labeling program, a biobased product, after being certified by USDA, 
can 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 Program Web site. This final rule applies to manufacturers 
and vendors who wish to participate in the voluntary labeling component 
of the BioPreferred Program. The final rule also applies to other 
entities (e.g., trade associations) that wish to use the label to 
promote biobased products.

DATES: This final rule is effective February 22, 2011.

FOR FURTHER INFORMATION CONTACT: Ron Buckhalt, USDA, Office of the 
Assistant Secretary for Administration, Room 361, Reporters Building, 
300 7th Street, SW., Washington, DC 20024; e-mail: 
<a href="/cdn-cgi/l/email-protection#8be9e2e4fbf9eeedeef9f9eeefcbfef8efeaa5ece4fd"><span class="__cf_email__" data-cfemail="b3d1dadcc3c1d6d5d6c1c1d6d7f3c6c0d7d29dd4dcc5">[email protected]</span></a>; phone (202) 205-4008. Information regarding the 
Federal Biobased Products Preferred Procurement Program (one part of 
the BioPreferred\SM\ Program) is available on the Internet at http://www.biopreferred.gov.

SUPPLEMENTARY INFORMATION: The information presented in this preamble 
is organized as follows:

I. Authority
II. Background
III. Summary of Changes
IV. Discussion of Public Comments
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 12988: Civil Justice Reform
    E. Executive Order 13132: Federalism
    F. Unfunded Mandates Reform Act of 1995
    G. Executive Order 12372: Intergovernmental Review of Federal 
Programs
    H. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    I. Paperwork Reduction Act
    J. E-Government Act Compliance
    K. Congressional Review Act

I. Authority

    Today's final rule establishes the voluntary labeling program for 
biobased products under the authority of section 9002 of the Farm 
Security and Rural Investment Act of 2002 (FSRIA), as amended by the 
Food, Conservation, and Energy Act of 2008 (FCEA), 7 U.S.C. 8102 
(referred to in this document as ``section 9002'').

II. Background

    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, 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 a preference 
to the purchase of biobased products (hereafter referred to in this 
Federal Register notice as the ``Federal 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 item(s) to be 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 product category 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.
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    \1\ The term ``designated item'' refers to product categories 
(generic groupings of products that perform the same function) 
within which the products have been afforded a procurement 
preference by Federal agencies under the BioPreferred Program. For 
example, under the designated product category ``mobile equipment 
hydraulic fluid,'' all brands and grades of hydraulic fluid 
formulated for use in mobile equipment and meeting the specified 
minimum biobased content are included in the procurement preference 
program.
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    The final guidelines for the Federal 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 product categories and specifies their 
minimum biobased contents, the effective date of the procurement 
preference for biobased products within each product category, 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.
    As part of the Federal 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 product categories 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 product 
category.
    To date, USDA has identified 50 product categories in a variety of 
applications, including cafeteria ware, personal and institutional 
cleaning products, construction products, and lubricants and greases. 
There are presently approximately 5,100 individual BioPreferred 
Products (products that are within product categories that are eligible 
for Federal preferred procurement) within these 50 product categories.
    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 certification mark''). 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 commercial

[[Page 3791]]

entities and the general public. In establishing this program, USDA 
must identify the criteria to determine those products on which the 
certification mark may be used and must develop specific requirements 
for how the mark can be used. It is USDA's intent that the presence of 
the certification mark 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 American Society of Testing and Materials (ASTM) radioisotope 
test D6866.
    In developing the 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 (FTC), 
which issues the ``Guides for the Use of Environmental Marketing 
Claims'' to ensure that the provisions of the voluntary labeling 
program are consistent with the Guides. USDA also held a public meeting 
on July 22, 2008, to seek input on the content and use of the 
certification mark from the public and industry stakeholders.
    As part of the BioPreferred Program, on July 31, 2009, USDA 
published a proposed rule for the voluntary labeling program for 
biobased products under the authority of section 9002. This proposed 
rule can be found at 74 CFR 38295.
    The following section of the preamble presents a summary of the 
changes that have been made to the rule as a result of USDA's 
consideration of the comments that were received on the proposed rule. 
Section IV presents a summary of the public comments received on the 
proposed voluntary labeling program and USDA's responses to the 
comments.

III. Summary of Changes

    As a result of comments received on the proposed rule (section IV), 
USDA made changes to the rule, which are summarized below. USDA 
discusses the rationale for these changes in section IV.
    Minimum biobased content. For finished biobased products that are 
not within the designated product categories and for intermediate 
ingredients or feedstocks that are also not within the designated 
product categories, USDA has lowered the applicable minimum biobased 
content from the proposed 51 percent to 25 percent.
    Mature market products. As a result of USDA consideration of public 
comments concerning the difficulty of implementing case-by-case 
exemptions, USDA has decided to categorically exclude mature market 
products from the labeling program at this time.
    Preliminary notice of violations. USDA has added a provision to the 
rule to provide manufacturers and vendors with a preliminary notice of 
violation.
    Initial approval process. Based on a commenter's recommendation 
that USDA allow representative biobased content testing for products 
with similar biobased contents but slightly different formulations, 
USDA has agreed to allow representative content testing to suffice if 
the product's formulation does not vary by more than 3 percent for 
multiple products.

IV. Discussion of Public Comments

    USDA solicited comments on the proposed rule for 60 days ending on 
September 29, 2009. USDA received comments from 25 commenters by that 
date. These comments were from individuals, manufacturers, and trade 
organizations.

Who can apply for the certification mark?

    Comments: One industry commenter states that vendors, especially 
those who sell private-labeled manufactured products, should be allowed 
to apply for biobased labeling. An example is a product that has been 
labeled by the manufacturer for one purpose; and the vendor would like 
to package it under its private label and for a different application 
(e.g., a road dust suppressant labeled by the manufacturer, could be 
labeled by a vendor as a ``COAL dust control agent'' under the vendor's 
private label). The latter product may require slight modifications by 
the manufacturer or be exactly the same. The vendor would use the 
documentation that the manufacturer has established along with 
additional information to apply for separate labeling.
    One industry commenter supports both manufacturers and vendors 
being eligible to apply for the certification mark and stated that this 
approach provides the maximum flexibility for all participants.
    One industry organization commenter and one industry commenter 
support manufacturers, but not vendors, being eligible to apply for the 
certification mark. The commenters state that it is the manufacturers 
who have the information on product composition (e.g., whether a 
product meets the definition of a biobased product) and biobased 
content (e.g., testing results on the formulated product). Having both 
vendors and manufacturers apply will result in USDA having to process 
many more applications for no reason. Furthermore, it is critical that 
manufacturers maintain control over who uses the certification mark on 
their products. Having a proliferation of vendors apply for the mark 
without the knowledge of the manufacturer will lead to confusion and 
potential misunderstandings.
    One individual commenter does not believe it would be a good idea 
to allow vendors to be eligible to obtain the certification marks. The 
commenter pointed out that, as noted in the proposed rule, it is the 
manufacturer and not the vendor who determines a product's formulation 
and production process. In addition, some manufacturers have become 
very upset when finding out that some vendors of their products were 
participating in the BioPreferred Program without their knowledge. The 
commenter envisions lawsuits arising when allowing vendors to apply for 
labels without documented consent from the manufacturer.
    Response: USDA continues to believe that the goals of the voluntary 
labeling program can be achieved, and the beneficial impacts of the 
BioPreferred Program can be increased, if both manufacturers and 
vendors are allowed to market and promote the manufacturers' biobased 
products with a credible biobased product labeling program. For 
example, many vendors purchase products from manufacturers and then 
repackage or offer these products as private label items. Allowing 
these vendors into the program will increase the number of biobased 
products in the market, thus furthering the goals of the program. 
Therefore, USDA will allow vendors as well as manufacturers to 
participate in the program as long as they meet all program 
requirements.

Applicable Minimum Biobased Contents

    Comment: One industry commenter states that he believes that a 
minimum biobased content of 50 percent should be required for products 
not within product categories that have been identified for Federal 
preferred procurement. Requiring half or more of a product's content to 
be biobased will bring credibility to the certification mark and 
prevent potential ``greenwashing'' by allowing lower biobased content 
product manufacturers to advertise the certification mark.

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Products containing less than 50 percent biobased content can still be 
identified through the BioPreferred designation process for Federal 
preferred procurement.
    One industry commenter recommends that USDA consider lowering the 
biobased content level to 20 percent for intermediate ingredients and 
feedstocks to be eligible to receive the BioPreferred certification 
mark. The commenter has commercialized a family of unsaturated 
polyester resins that are used to fabricate fiberglass-reinforced and 
particulate reinforced composites used in an increasingly wide variety 
of applications in the transportation and building and construction 
industries. The biobased content in these commercially-available resins 
falls in the 8 to 22 percent range. They currently have developmental 
products with biobased content in the 30 to 40 percent range. The 
commenter recommends that the biobased content eligibility cut-off for 
a label be set at 20 percent, not only for these types of products but 
for chemical intermediates and feedstocks in general. The commenter 
believes that this level will stimulate further consumption of existing 
resins and incentivize companies to continue to develop biobased resins 
with even higher biorenewable content.
    One industry organization commenter believes that for finished 
products that do not fall within an existing product category 
identified for Federal preferred procurement the default biobased 
content percentage should be lower (e.g., 25 percent). More flexibility 
is needed in setting a default standard for finished biobased products 
that have not yet been identified for Federal preferred procurement. 
This is a new industry that is creating a range of end products, each 
of which needs to meet different performance standards depending upon 
the type of product. It is not always possible to meet accepted 
industry performance standards and achieve a 51 percent or greater 
biobased content.
    One industry organization supports a minimum biobased content of 
anywhere between 20 and 51 percent for both intermediate ingredients 
and products that do not fall within an existing product category 
identified for Federal preferred procurement.
    Two industry commenters believe the proposed 51 percent minimum 
biobased content is inappropriately high. One of the commenters states 
that they understand the desire to establish the highest possible 
biobased content, but that performance requirements in many 
applications cannot be met with such high biobased content. The 
commenter suggested that USDA review the minimum biobased contents that 
USDA has set for products within the existing product categories 
identified for Federal preferred procurement, and establish a minimum 
for products not within those categories which would be more inclusive 
than the proposed 51 percent. The commenter stated that this would 
allow program expansion without greatly increasing the administrative 
burden. The commenter stated that, for example, if the minimum biobased 
content was set at 20 percent, then 44 of the 49 categories of 
identified items would meet this criterion. Selecting 51 percent 
appears to be arbitrary as there is no rationale provided in the 
proposed rulemaking for this minimum. The commenter further stated that 
USDA has developed a rigorous process for identifying the BioPreferred 
Products that have been identified for Federal preferred procurement. 
The BioPreferred Products to date represent a reasonably sized 
``sample'' of biobased products currently on the market. Selecting a 
minimum biobased content of 20 percent for the labeling program covers 
at least 90 percent of the product categories identified for preferred 
procurement to date by USDA. The other commenter notes that the 
existing minimums for several of the product categories are well below 
that 51 percent threshold and states that if the bar had been set so 
high when products within these categories were being developed, it 
could have inhibited that development. Additionally, these products 
were developed even before the incentive from USDA. To the degree that 
the USDA program will incentivize future development, setting the bar 
this high could inhibit that same development. The commenter believes 
it might be more realistic to set the default minimum biobased content 
somewhere in the lower end of the range (15 to 20 percent) of the 
minimum biobased contents specified for product categories already 
included in the BioPreferred Program, with the expectation that most 
products' biobased contents will increase as technology advances.
    Two industry organization commenters and one industry commenter 
state that USDA's proposed approach to establishing and enforcing 
biobased content levels does not take into account the imprecision in 
the analytical testing method used to determine biobased content or 
manufacturing variations in the production of different batches of 
products or small formulation changes.
    On the first point, the ASTM D6866 test method has precision of +/- 
3 percent on the mean biobased content reported. Because of this, USDA 
has previously recognized the need for flexibility when establishing 
minimum biobased content levels for BioPreferred Products. The 
commenters urge that USDA take the same approach in the labeling rule. 
Products should be eligible for certification if their biobased content 
falls within 3 percentage points of the minimum content level and 
should be considered in compliance if their content falls within 3 
percentage points of their label statement. Manufacturers should not 
have to reapply for certification if their product's biobased content 
falls within 3 percentage points of their label statement.
    On the second point, the commenter stated that in any manufacturing 
process there will be some production variation. Also, small changes 
can be made to formulas over time. Therefore, the commenters urge USDA 
to allow a manufacturer applying for a label certification to establish 
a biobased content for the purpose of the label that may be below the 
actual D6866 test results in order to account for manufacturing 
variations. The commenter stated that, as currently written, the 
applicant does not appear to have that flexibility. The proposed rule 
appears to require that the percentage biobased content used for the 
label be exactly what is reported in the lab test results submitted 
with the application.
    One industry commenter stated that he supports allowing 
intermediate ingredients such as biobased plastic resin to be eligible 
for the voluntary labeling program and that, for those products, the 
certification mark should reference the product's biobased content, 
with a minimum of 50 percent biobased content.
    One industry organization commenter requests clarification of the 
definition of ``intermediate ingredients or feedstocks,'' but states 
that he supports a required biobased content level of anywhere within 
20 to 50 percent for intermediate ingredients and for the final 
products that are not within product categories identified for Federal 
preferred procurement. The commenter also supports the inclusion of 
biobased intermediates as eligible to receive the certification mark 
under the current rulemaking.
    Response: The majority of the public comments received on the 
proposed 51 percent minimum biobased content for finished biobased 
products, as well as intermediate ingredients and feedstocks, that are 
not within product categories

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identified for Federal preferred procurement recommended that the level 
be lowered. Based on USDA consideration of these public comments, as 
well as other factors, USDA has reconsidered the applicable minimum 
biobased content requirement and concluded that a 25 percent minimum 
biobased content is more appropriate.
    As pointed out by the commenters, several product categories that 
have been identified for Federal preferred procurement have applicable 
minimum biobased contents less than the 51 percent minimum that had 
been proposed for (1) finished biobased products and (2) intermediate 
ingredients or feedstocks that are not within product categories that 
have been identified for Federal preferred procurement. For example, 
``general purpose laundry products'' which were identified in Round 4 
of the ``Designation of Biobased Items for Federal Procurement'' have 
an applicable minimum biobased content level of 34 percent, 17 percent 
lower than the proposed biobased content minimum for certification.
    USDA considered the fact that, on a global basis, many other 
entities promoting the development and use of biobased products 
recognize those products that have biobased contents of less than the 
proposed 51 percent. For example, two European Union independent 
certifying organizations, DIN-CERTCO (Germany) and AB Vincotte 
(Belgium), specify 20 percent as the minimum acceptable biobased 
content for products they certify as biobased. The Japan BioPlastics 
Association, which certifies biobased products for Japan, Korea, and 
China, specifies 25 percent as the minimum acceptable biobased content 
for products they certify as biobased.
    USDA also considered that adopting a lower minimum biobased content 
criteria for these products will allow a greater number of new biobased 
products to receive the benefits of the label. This, in turn, is 
expected to lead to increase sales of those biobased products. In 
addition, many of these new products will increase in biobased content 
over time with advances in materials engineering and technology. For 
example, the biobased foam used in automobiles originally had a 
biobased content in the 5 to 10 percent range but has now increased to 
over 30 percent biobased.
    Therefore, USDA believes that lowering the applicable minimum 
biobased content for both finished products and intermediate materials 
that are not at present BioPreferred Products would further the goals 
of the program and allow for a greater number of biobased products to 
use the certification mark. This will create more visibility for the 
labeling program, helping to achieve the goals of the program, and 
further encourage emerging markets because it will, as one commenter 
noted, ``incentivize future development.''
    Because of the variability in product testing, as noted by one 
commenter, USDA is setting the minimum biobased content levels for 
products eligible for the Federal preferred procurement program 3 
percent lower than that of the tested product upon which the minimum 
level is based. However, for the labeling program, the 25 percent 
minimum biobased content is not based on testing of an actual product, 
but is a USDA policy decision based on consideration of the factors 
described above. Applicants must meet the minimum biobased content 
percentage they report for a product and should take the testing 
variability into account when applying for product certification. As 
such, a manufacturer or vendor may want to claim a more conservative 
biobased content percentage for a product in its application for 
certification to use the label. Thus, to ensure that test results 
consistently meet or exceed the biobased content stated in the 
application, manufacturers may want to claim a biobased content 3 to 5 
percent lower than test results have indicated.
    Comment: Two industry organization commenters urge USDA to clearly 
specify the procedure and steps by which an applicant can request an 
exception to any specific minimum biobased content chosen for the final 
rule.
    Response: USDA is working to standardize this process and 
anticipates that it will be similar to the process used to set product 
minimum biobased contents for eligible products in the Federal 
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 
in providing products for testing. However, similar to the process used 
in the Federal preferred procurement program, the establishment of 
alternative minimum biobased 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.

The Labeling of ``Complex Products''

    Comment: Three industry organizations strongly agree with USDA that 
complex products are finished products, are separate and distinct from 
biobased products, and should be included in the BioPreferred Program's 
labeling program. The commenters support including ``complex products'' 
in the labeling effort. The commenters believe that complex products 
can be included in the rule even in the absence of a test method to 
determine the overall biobased content of a complex product. If a 
complex product, such as a car, includes components that contain 
biobased products (e.g., seats, headliners, dashboards), it is not 
practical, or even meaningful, to test and or calculate the overall 
biobased content of the car. Rather, there should be an option to label 
the components with the biobased content. Two of the commenters state 
that one approach for doing this would allow a component (e.g., seat) 
that contained a ``USDA Certified Biobased Product'' to be eligible to 
use the certification mark. For example, if the foam used to make the 
seat had a certification to use the mark then that certification could 
be carried through to the seat. The mark could read: ``Seat: Contains 
Foam with XX Percent Biobased Content.'' Another approach would be to 
allow the component to be tested separately for biobased content or a 
weighted average of the biobased ingredients could be calculated and if 
it met the default percentage it would be eligible for the 
certification mark. If it did not, the manufacturer or vendor could 
apply to USDA for an ``alternative applicable minimum biobased 
content.''
    Three commenters propose that, to determine the biobased content of 
a complex product, an interim approach would be to (1) take a weighted 
sum (e.g., weight of component 1 x new carbon content of the feedstock 
material used in component 1 + weight of component 2 x new carbon 
content of the feedstock material used in component 2; etc. until all 
components have been included) and then (2) normalize this number by 
the total

[[Page 3794]]

weight of the complex product. Consistent with USDA's current 
requirements, the new carbon content should be determined using ASTM 
D6866.
    These commenters recommend that, as a long term approach, USDA 
continue to consult with ASTM to gather information on complex products 
to proceed with the development of a method that can be used to 
determine the biobased content of these products. Once an acceptable 
test method is available, the commenters agree that USDA should amend 
the voluntary labeling rule to allow for the labeling of complex 
products.
    One industry commenter states that care should be taken to not 
complicate the labeling process. A wind generator that uses biobased 
grease or gear lubricants, and biobased composites for the blades 
should indicate that the blades are biobased and the gear lube is 
biobased. Trying to qualify what percent of the total wind generator is 
biobased would complicate the process.
    One industry commenter suggests modifying the term ``complex 
products'' in the labeling program to ``complex finished products'' to 
avoid any confusion with polymer systems. The commenter believes that 
``complex finished products'' can be included in the rule even in the 
absence a test method to determine the overall biobased content of a 
complex finished product.
    One individual commenter believes that, for complex products, it 
would be unwise to base the biobased content on weighted averages for 
the biobased content of all the biobased components. This approach 
would be too costly for some product manufacturers to consider and 
could hinder participation in the program. In addition, the total error 
associated with the weighted average will increase considerably (due to 
cumulative errors) as the number of components within a complex product 
increases. As a result, the total error associated with any given item 
(or between individual products within an item) will be product-
specific, which is undesirable from a designation perspective.
    One industry commenter states that many of these complex products 
will contain components manufactured from biobased and non-biobased 
materials. In some cases, the use of biobased intermediate ingredients 
or feedstocks in components may not represent a significant amount of 
the finished product (i.e., contains less than 51 percent biobased 
content). However, the use of biobased materials may represent a 
significant improvement for the finished product that should be 
encouraged.
    One industry commenter also believes that it is important to look 
at subcategories as well as categories of products because there are 
often performance requirements that place limits on the amount of 
biobased materials that can be used for certain specific applications 
within the same product categories. For example, the amount of biobased 
content in foam used in automotive seating can vary from the amount 
used in foam seating for sofas due to performance requirements.
    Response: USDA appreciates the comments on this subject but has 
decided it is best not to include complex products in the voluntary 
labeling program at this time. USDA recognizes the importance of 
complex products but believes there are many issues to be resolved 
before such products can be included in and recognized by the labeling 
program. These issues include establishing a minimum biobased content 
and other criteria for approval, development of an acceptable test 
procedure to determine the biobased content of complex products, and 
the appropriate certification mark content and placement. USDA does not 
want to delay the implementation of the labeling program for other 
categories of more simple, finished products while this development 
work for the labeling of complex products is being completed.

The Labeling of ``Mature Market Products''

    Comment: Six commenters agree with USDA's proposal that products 
that are considered to be ``mature market products'' (i.e., products 
that had significant market penetration in 1972) should not be eligible 
for participation in the labeling program of the BioPreferred Program 
as mature market products could affect the entry of new (i.e., post-
1972) biobased products into market segments in which mature products 
already have significant market shares. The commenters believe that 
inclusion of ``mature market products'' would be counter to USDA's 
objective to promote development and adoption of new technologies and 
biobased products.
    Two of the commenters questioned why the date of 1972 was selected 
as the cut-off year for products to be included in the ``mature 
market'' category and one commenter requested that USDA provide 
additional information including defense and rationale regarding the 
selection of 1972. The commenter notes that USDA may decide to allow 
manufacturers of mature market products to appeal and states that USDA 
should make clear the information regarding the criteria by which a 
manufacturer of mature market products can appeal, the details of the 
appeal process and how USDA will determine if an appeal is approved or 
not. The commenter also recommends that if manufacturers of ``mature 
market products'' are allowed to appeal, then the appeal process should 
include a public comment period to allow the public to review the 
appeal and to submit comment about it.
    Two commenters recommend that USDA not allow manufacturers of 
biobased products to appeal, on a case-by-case basis, the exclusion of 
their mature market products. The commenters state that, in enacting 
section 9002, Congress made it clear that the purpose of the program, 
including the labeling program, was to grow the market for new biobased 
products. The value of the certification mark for manufacturers and 
vendors of these products is to inform consumers that these new and 
innovative products are available and that USDA has certified the 
biobased content. The ``currency'' of being a new and innovative 
product loses its meaning and quickly the label may become 
``devalued.'' Furthermore, mature market products have other already-
established, and well known labels (like the cotton logo and FSC 
certification for wood and paper products) that they can use. The 
commenters recommended that any government label for mature market 
products be developed separately and under different authority than 
Section 9002.
    One industry commenter states that the labeling of mature products 
would harm the BioPreferred Program's labeling process in the early 
stages. A 5- to 10-year delay before such mature products are allowed 
to be included and labeled would be helpful.
    Two commenters are concerned that the proposed regulations exclude 
mature market products from the program, except on a case-by-case 
basis, and could be interpreted as excluding forestry materials that 
fit properly within the definition of biobased products in the 
authorizing legislation.\2\ One of the commenters believes such an

[[Page 3795]]

exclusion would be arbitrary and capricious in violation of the 
Administrative Procedure Act, 5 U.S.C. 706. Additionally, the commenter 
believes the proposed certification mark violates the consumer 
advertising rules of the FTC.
---------------------------------------------------------------------------

    \2\ The definition of ``biobased products'' found in the 2008 
Farm Bill is 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.''
---------------------------------------------------------------------------

    This commenter, and another individual commenter, believe that the 
exclusion of mature market products from automatic inclusion in the 
voluntary labeling program should be eliminated for the following 
reasons:
    <bullet> There is no legitimate difference between new and mature 
products in a voluntary public information program;
    <bullet> There is no guidance on recognizing a product as ``new'';
    <bullet> The proposal provides for a case-by-case determination 
that would allow some mature market products to use the voluntary 
label; and
    <bullet> USDA assumes that Congress intended that the voluntary 
label program exclude mature market products, but the legislative 
history does not reflect this interpretation.
    One of the commenters states that USDA needs to understand that 
even ``mature'' products can be ``renewed'' through innovations and 
following new industry standards such as sustainable forestry 
management programs.
    One industry commenter suggests that USDA extend applicability of 
the label to all biobased products. Alternatively, USDA should amend 
the proposed language on the label to clearly designate it as intended 
for emerging market products only.
    One nonprofit organization commenter has concerns about the nature 
of this label on the consumer market especially where it might lead a 
consumer to make assumptions about the overall sustainability of their 
purchase. The BioPreferred Program seems to provide a quantitative 
basis to the natural content. However, the commenter believes that 
exceptions for materials like wool or cotton for rugs, for example, 
could mislead a consumer to make a less environmentally preferable 
choice if they relied on the certified biobased product certification 
mark.
    One industry commenter believes that specifically excluding the 
mature market products will establish a system that creates the 
perception that USDA endorses the use of ``new'' products over mature 
market products, even if the new products contain less biobased 
materials than a competing mature product. This will, in turn, 
encourage consumers to make purchasing decisions that are counter to 
Congressional intent. For example, a paper plate, which USDA has 
characterized as a ``mature market'' product, could not use a certified 
biobased label despite the fact that it is made with close to 100% 
biobased material. On the other hand, a new plastic plate that is 
composed of only 51% corn-based PLA could qualify for the certification 
mark under USDA's proposed rule. This would be both confusing and 
misleading to the consumer resulting in the conclusion that the 
conspicuous use of a USDA-backed certification mark on the plastic 
plate constitutes a government endorsement. The consumer may also 
conclude that forestry practices, no matter how sustainable, are less 
environmentally preferable to synthetic polymers made from agricultural 
products. The commenter believes that excluding mature products will 
provide an unfair competitive disadvantage for these products and 
severely discount the environmental contributions of biobased forest 
products.
    One industry commenter states that since the label will be limited 
to a small pool of biobased products, they are concerned that the 
proposed label will increase customer confusion in an already chaotic 
labeling environment. Consumers will have no basis to determine why one 
biobased product carries the certification mark and one does not. While 
the designation between emerging and mature market products may be 
acceptable in a relatively closed Federal purchasing system, expanding 
this concept to the broad consumer marketplace under a simplistic 
labeling scheme will only increase consumer confusion. The proposed on-
product USDA label does not provide clarification that it is intended 
for emerging market products only. A consumer, looking at a mature 
market biobased product, will have no idea why it is not (or cannot be) 
USDA certified as biobased.
    One environmental group commenter states that he does not 
understand why the labeling program would exclude mature market 
products while allowing biobased labeling of more recent entrants in 
the same market. This has the effect of favoring one biobased product 
over another based solely on their market maturity, rather than being 
based on any rational criteria related to reduced use of fossil fuels, 
carbon cycle benefits, or environmental sensitivity. The commenter 
states that the rules should be amended to avoid punishing 
environmentally favorable ``mature'' products, while encouraging 
environmentally less favorable ``new'' market entrants.
    Response: USDA received numerous comments both for and against the 
exclusion of mature market products from the voluntary labeling 
program. While USDA has carefully considered the comments received on 
the subject, 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.'' Thus, USDA believes it is appropriate for the guidelines to 
exclude products having mature markets from the program.
    The conference report does not specifically state whether the 
language quoted above refers to only the Federal preferred procurement 
program, the voluntary labeling program, or both. However, USDA 
believes that the widespread labeling of mature market products could 
negatively affect the entry of new biobased products into market 
segments in which mature products already have significant market 
shares. Therefore, USDA continues to believe that it is reasonable to 
exclude mature market products from the labeling program, as it has 
done for the Federal preferred procurement program.
    Regarding the 1972 cutoff year, as explained in the preamble to the 
final guidelines, the oil supply and price shocks that began in this 
country around 1972 provided the impetus for sustained serious new 
development of biobased alternatives to fossil-based energy and other 
products. Additionally, there was a return to existing, perhaps 
neglected or under-utilized, biobased products. Thus, at its 
discretion, USDA has selected 1972 as the baseline year in its mature 
market guidance, consistent with the approach taken for the Federal 
preferred procurement program. In using 1972 as a point in time 
standard, rather than a dividing line between two eras, USDA believes 
this can provide for the identification (for Federal preferred 
purchasing) and labeling of some products that would otherwise be 
excluded.

The Appropriate Lengths for the Certification Periods

    Comment: Four commenters recommend that certifications should 
remain valid as long as the certified product is manufactured. However, 
any change that would have any effect on the new carbon content and 
impact biobased content would necessitate the product being retested 
and recertified using ASTM D6866. Since USDA will be implementing an 
audit and enforcement program, this program should be adequate to 
ensure that applicants remain in compliance with the BioPreferred 
Program.

[[Page 3796]]

    One industry commenter states that the appropriate length of 
certification in the early stages should be longer (5 years) and once 
the industry matures, reduced to 3 years. A simple annual response to a 
survey by USDA indicating that there have not been any changes to the 
labeled product could help USDA monitor products that are discontinued 
and keep the vendors active.
    Response: Most commenters agree with USDA's proposal that a 
product's certification should remain valid indefinitely unless USDA 
raises the minimum biobased content requirements for that specific 
product or the formulation of the product changes such that it falls 
below the minimum biobased content allowed for that product to be 
labeled. USDA has received no additional data or information to 
consider changing its decision in this regard and is making no change 
to the proposed regulation based on these comments.

Preliminary Notice of Violations

    Comment: Two industry commenters support USDA adding a provision to 
allow for the Agency to issue ``preliminary'' notices of violation 
before violation notices are issued. It is a sensible safety valve to 
add to the regulations to prevent triggering violation notices 
prematurely. This step can provide time to allow a manufacturer or 
vendor to work with USDA to clarify whether, due to confusion or 
misinformation, a violation really has not occurred. Also, if there was 
a paperwork or recordkeeping error it could be corrected in response to 
a preliminary notice without triggering a violation notice and all its 
consequences.
    Response: USDA agrees with the commenters and will include a 
provision for a preliminary notice of violation. Doing so will give 
manufacturers and vendors the opportunity to work with USDA to make 
corrections or clear up any issues which might place the manufacturer 
or vendor in violation. USDA believes that the labeling program is 
designed to encourage the production, marketing, and distribution of 
biobased products, not to be punitive in nature, and the use of a 
preliminary notice of violation will best serve the goals of the 
program.

Biobased Content Testing Facilities

    Comment: Four commenters agree with USDA's proposal requiring that 
biobased content testing facilities be ISO 9001 conformant to promote 
data and results credibility. This would ensure that the manufacturer 
is complying with some basic quality requirements. One commenter 
believes ISO 17025 will be too demanding.
    Two industry commenters also state that they support allowing 
biobased content to be tested by any third-party ASTM/ISO compliant 
test facility.
    One industry organization commenter believes that USDA should not 
select a single standard, such as ISO 9001 or ISO 17025, for biobased 
content testing laboratories but rather should allow for the biobased 
content testing to be done by any third party ASTM/ISO compliant 
testing facility. The USDA Guidelines for Item Designation take this 
approach and the labeling rule should be consistent with the testing 
facility provisions in the Guidelines.
    One individual commenter recommends that neither ISO certification 
nor ISO compliance should be a requirement. The commenter states that 
there are basically only two labs in the country that are performing 
biobased content determinations for the BioPreferred Program, and no 
new radiocarbon testing labs with interest in performing biobased 
content measurements have ever started up. Since there are so few 
suitable labs available, the commenter does not believe USDA should 
risk restricting the field further. The focus should be on 
qualifications rather than ISO compliance.
    Response: USDA continues to believe that it is in the best interest 
of the labeling program that biobased testing be performed by ISO 9001 
conformant testing facilities. This will ensure that biobased products 
using the certification mark meet the high standards of the program. 
USDA believes it is important that the presence of the certification 
mark on a product will clearly indicate that the product is one for 
which credible information is available as to the biobased content, 
consistently measured across labeled products, as use of the ASTM 
radioisotope test D6866 standard will provide.

Contents and Appearance of the Certification Mark

    Comment: Three commenters agree that the material (e.g., product, 
packaging or both product and packaging) to which the label applies 
should be clearly identified, and believe that USDA's suggested wording 
for ``product'' and ``packaging'' is clear.
    One industry commenter states that he has no issues with the ``FP'' 
on the USDA certified biobased product graphic (i.e., the certification 
mark) and that as long as the program includes an educational campaign 
that describes the mark, there should be no consumer confusion about 
what it means.
    Two commenters believe the way the ``FP'' lettering is placed on 
the certification mark may not be adequate to distinguish the products 
that are eligible for Federal preferred procurement. One commenter 
states that the ``FP'' visually seems to disappear on the mark. Also 
the letters ``FP'' are not likely to have any identifiable meaning to 
either Federal employees or the general public without an outreach and 
education program on what ``FP'' means and how the Federal preferred 
procurement program works. The commenter does believe that it is 
important for Federal buyers to have an easy way to recognize products 
that fall within designated product categories. The commenter suggests 
that the following language be on the final label (under the text that 
now reads ``USDA Certified Biobased Product'') for BioPreferred 
Products currently eligible for Federal preferred procurement: 
``Federal BioPreferred Designated Product.'' In addition, the commenter 
recommends implementing a targeted outreach and education campaign to 
Federal buyers to educate them on the meaning of the label for a 
product eligible for preferred Federal purchasing versus a product 
likely to be labeled that is not currently eligible.
    Two commenters oppose the proposed ``FP'' designator to indicate 
that a product is eligible for Federal preferred procurement. One of 
the commenters does not believe that the ``FP'' designator is necessary 
to inform Federal procurement officials about these items because these 
officials already have access to a list of the products eligible for 
Federal procurement preference. The commenters believe that consumers 
will not recognize the ``FP'' lettering on products, nor will they 
understand that these products, or similar products, have undergone 
life cycle costs and environmental performance analyses. Incorporation 
of the ``FP'' lettering may confuse the consumer regarding the purpose 
of the certification mark and will unnecessarily clutter and interfere 
with what is otherwise needs to be a clean, simple graphic.
    One commenter believes that the certification mark will provide 
little benefit to the average consumer and that using ``FP'' will tend 
to confuse matters, while another commenter believes that the ``FP'' 
information is irrelevant to the labeling program as currently 
proposed.
    Four commenters disagree with the inclusion on the certification 
mark of information on product performance, life-cycle costs and 
environmental and

[[Page 3797]]

human health effects of the labeled products. The commenters believe 
trying to add this information would likely make the certification mark 
confusing to purchasers, is beyond the scope of the labeling program, 
and is not authorized by the statute.
    One industry commenter states that the Farm Bill requires USDA to 
look at environmental impacts beyond biobased content as one of four 
criteria for the Federal preferred procurement program but that they do 
not think that this should be required for the voluntary labeling 
program. Biobased products manufacturers should be encouraged to 
provide additional environmental information and USDA should provide 
space on the website to communicate this rather than requiring it on, 
or near, the certification mark. If additional marketing claims are to 
be made on the package for purpose of communicating with consumers, 
this would fall under the jurisdiction of the FTC.
    One industry commenter states that printing sustainability 
information on a bag or package is an issue that needs further 
consideration. This adds more cost and ink to each bag of insulation 
which may go to landfill or be recycled. This information is normally 
included in product literature and specifications. It is also typically 
on the website of the manufacturer. It is more sustainable to provide 
product information in this manner than to print it on the package.
    Three commenters support including the percentage biobased content 
on the certification mark. One of these commenters believes this 
provides another critical way in which purchasers can select products 
that have the highest biobased content possible. Another commenter 
states that by displaying the percent biobased content, the consumer is 
able to make a purchasing decision based on actual content.
    One industry organization commenter states that there is not 
complete agreement among manufacturers on whether biobased content 
should appear on the certification mark. The commenter believes that 
USDA should carefully weigh the pros and cons of this label content 
issue. One approach would be not to list any content information on the 
certification mark because the mark will only be used on products that 
met the minimum biobased content established by USDA. Another approach 
would be to add the words ``Meets or Exceeds USDA Minimum Biobased 
Content.'' Another approach would be to give manufacturers the option 
of listing the biobased content percent on the mark or simply stating 
``Meets or Exceeds the USDA Minimum Biobased Content.'' If USDA 
requires that a specific biobased content percent be placed on the 
certification mark, then flexibility should be given to manufacturers 
to use a number that reflects testing and manufacturing variability, as 
long as the number equals or exceed the minimum content requirement.
    One industry commenter states that including only the biobased 
content on the certification mark implies that only that criterion is 
relevant. USDA determines the minimum acceptable biobased content based 
on several factors, including commercially available offerings, 
performance requirements in the application, etc. Such multi-factor 
considerations have lead to a wide range of minimum acceptable biobased 
contents, from 7 to 95 percent, across the range of product categories 
and applications. If the certification mark exclusively highlights the 
biobased content, this could send a misleading signal to the consumer 
that biobased content is the only relevant factor. The commenter 
suggests that, instead of including the percent biobased content on the 
mark, include the BioPreferred Program website URL in that proposed 
location on the label/artwork. This would encourage consumers to become 
more informed about the program. Individual manufacturers would still 
have the option of including additional information regarding biobased 
content elsewhere on the package, separate from the label itself. Such 
claims would be subject to the guidance from the FTC ``Guides for the 
Use of Environmental Marketing Claims.''
    One industry commenter suggests that including the biobased content 
on the label be left to the discretion of the various companies. The 
commenter states that the current state-of-the-art of biobased analytic 
calculation remains not very accurate and this could open the doors to 
issues when a specific number will be indicated on a certification 
mark.
    One industry commenter states that as long as the products meet the 
minimum biobased content set by USDA, what relevance does ``Product: x 
percent biobased'' add? This would lead to a ``specmanship'' 
competition in the market.
    One industry commenter recommended the following options for 
including the percent biobased content on the label (listed in order of 
preference):
    A. Allow the manufacturers the option of listing the biobased 
content or the wording ``Meets or Exceeds USDA Minimum Biobased 
Content'';
    B. Require the listing of actual biobased percent of the product 
(within the tolerance of standard test variability); or,
    C. If manufacturing variability of actual percent content is a 
significant issue, then require a numerical percent value, but rather 
than requiring listing actual percent or the minimum required percent, 
the manufacturer has the option of stating a percent content higher 
than the minimum but lower than their ``normal'' tested value.
    The commenter states that the BioPreferred Program would benefit by 
requiring one of the above label alternatives as they would serve as a 
continual incentive for manufacturers to maximize their biobased 
content. Conversely, it could be a deterrent to add lower cost non-
renewable blends to a level just above the minimum allowed.
    One biobased industry commenter would like to see a very simple 
label without the specific biobased content. The minimum biobased 
content is established for BioPreferred Products and for other products 
it will be 51 percent unless USDA approves an alternative. Therefore, a 
supplier simply needs to certify that their product meets the minimum 
standard for that product(s) and USDA needs to enforce to that biobased 
content level. If a company has a higher biobased content than that 
minimum, then they can market that product in their literature as such.
    One industry commenter believes that the logo is quite large and 
that USDA should reconsider the size. Product labels have limited 
space, and the graphic as shown in the draft voluntary labeling rule, 
is overly large. Although the label can be reduced, it would be to the 
point of not being readable or recognizable.
    One industry organization commenter supports the proposed 
requirement that the BioPreferred Program's Web site address either be 
on or in close proximity to the label. Directing people to the site 
will be a good way to educate them about biobased products and what the 
certification mark means.
    One environmental group commenter states that the label should 
include a detailed information box adjacent to the logo, so the 
consumer knows the source of the bioproducts, the energy inputs used in 
their manufacture, and if any native ecosystems were degraded in the 
production process.
    One industry organization commenter believes that products that use 
the biobased product label must also state on the label the biological 
components of the product.

[[Page 3798]]

    One industry organization commenter believes that the information 
USDA proposes be included is reasonable and should be legible on the 
vast majority of products. For products that may be too small to affix 
the certification mark in a legible form, USDA should consider 
authorizing the use of a separate ``hang tag'' containing the 
certification mark information that could be attached to the product. 
This approach would address the small product issue without the need to 
change the overall design of the mark artwork and accompanying 
statement.
    One individual commenter believes that, in order to better 
accommodate labeling of small products (e.g., lip balm), it would be 
advantageous to also offer a version of the certification mark that 
does not contain the words ``USDA Certified Biobased Product.'' Such a 
mark would be intended only for products where it would be very 
problematic to use the certification mark as currently proposed.
    One industry commenter states that he believes USDA should budget 
an extensive education campaign to generate brand awareness of the 
certification mark both within Government and to the public. Similarly, 
brand guidelines should be developed to ensure proper stewardship of 
the mark.
    One industry commenter states that the certification mark must be 
in full compliance with the FTC's Guides on the Use of Environmental 
Marketing Claims. The commenter also states that consumer testing must 
be undertaken to determine whether the intent of the certification mark 
is clearly understood.
    Two industry commenters recommend that USDA develop and make 
available with its certification mark a simple set of guidelines 
regarding the proper usage of the mark and accompanying text to ensure 
a legible and consistent presentation of this information.
    Response: As stated in the proposed rule, USDA will create 
guidelines to address recommended certification mark size, given the 
variability in biobased product and packaging dimensions. These 
guidelines are referred to in the proposed rule as the ``Marketing 
Guides.'' These guides/guidelines will be available to manufacturers 
and vendors of labeled products to provide expanded discussions of, and 
guidance on resolving, implementation issues that may arise related to 
certification mark use. For example, USDA anticipates that there will 
be questions related to the best way to apply the certification mark on 
very small products, such as those within ``lip care products'', a 
product category whose products are identified for preferred Federal 
purchasing. USDA believes that the Marketing Guides, which can be 
updated frequently, are the most efficient way to keep certification 
mark users informed of guidance provided by USDA in response to 
implementation issues that arise. Additional information on 
sustainability and other data will be Web-hosted, not affixed to the 
mark.
    Additionally, USDA consulted the FTC, which issues the ``Guides for 
the Use of Environmental Marketing Claims'' to ensure that the 
provisions of the voluntary labeling program were consistent with the 
Guides. If manufacturers or vendors include environmental claims about 
biobased products on their products/packaging (beyond the application 
of the certification mark) these statements and/or marketing language 
may be flagged and forwarded to the FTC for their review and follow-up.
    Further, while USDA appreciates the concerns of commenters who 
would like to see more environmental and performance information on the 
certification mark, USDA believes that the certification mark needs to 
be kept as simple as possible to maintain legibility and clarity. 
Adding further information to the mark will only make it more difficult 
to read and understand, lessening the impact of the label and the 
BioPreferred Program.
    While some commenters believed that the ``FP'' acronym proposed to 
appear on the certification mark was confusing, others believed that 
the acronym would be helpful to Federal procurement officials and also 
informative to the general public. Some commenters felt the biobased 
content percentage proposed to appear on the certification mark was 
confusing and/or misleading, and felt that a large-scale outreach and 
educational campaign may be necessary to educate potential buyers on 
the meaning and purpose of this information. USDA considered the 
comments related to the proposed content of the certification mark and 
believes that the mark would be most informative if it includes both 
the ``FP'' (if the product has been designated for Federal preferred 
procurement) and the biobased content percentage, as proposed. Also, to 
ensure that the certification mark clearly indicates whether it applies 
to the product, the packaging, or both, the mark will be available in 
the following variations: ``USDA Certified Biobased Product'', ``USDA 
Certified Biobased Product: Package'', or ``USDA Certified Biobased 
Product & Package'', to be used as appropriate.

Timeframe for Correcting Violations

    Comment: Four commenters agree with USDA's recommendation for 30- 
and 60-day periods (from the date the notice of violation is received) 
for the offending party to correct violations before a notice of 
suspension or other remedy is sought. Two of the commenters state that 
to provide more flexibility, USDA could consider adding a provision for 
case-by-case extensions of the 30- and 60-day periods to deal with 
special or extenuating circumstances (such as late reporting by a lab).
    One industry commenter states that notice of violations should be 
given 30 days to respond and 60 to 90 days to correct.
    One industry association commenter proposes a 60-day time period to 
correct violations pertaining to biobased content to ensure adequate 
timing to correct any identified issues. In addition, the commenter 
agrees with USDA's recommendation for a 60-day period for the offending 
party to correct all other violations before a notice of suspension or 
other remedy is sought.
    Response: Most of the commenters addressing this issue agreed with 
the proposed 60-day time period for correcting violations. However, 
USDA recognizes that as the voluntary labeling program is not a 
regulatory program but a market development program, USDA needs to be 
as understanding as possible while maintaining a firm date of 
enforcement. For these reasons, USDA has decided to allow 90 days for 
the correction of a violation once a notice of violation is received.

Recordkeeping

    Comment: Four commenters support USDA's proposal that appropriate 
records be kept in order to allow USDA to verify all information 
associated with the labeling program and that these records be kept for 
at least 3 years beyond the end of the label certification period.
    One commenter supports USDA's plan to require documentation 
supporting claims made on product packaging about the environmental and 
human health effects, life cycle costs, sustainability benefits, and 
performance of their products. This is especially important given the 
widespread misuse of biodegradability claims, and unsubstantiated 
compostability claims, being made by product manufacturers. When 
including claims regarding compostability on the certification mark or 
product packaging, manufacturers

[[Page 3799]]

should have to detail the specific environment in which the product 
will fully biodegrade and for which they can provide documentation.
    One of the commenters states that records should not be required to 
be kept for analyses of environmental, health, sustainability benefits, 
life cycle costs, or product performance because these are outside the 
scope of the labeling program. Even if manufacturers or vendors are 
making specific claims in these areas, USDA does not have jurisdiction 
to enforce the validity of such claims. Also, records should not be 
required to be kept for formulation changes that are not relevant to 
the label criteria, such as changes in non-biobased ingredients, or 
changes in biobased ingredients that do not result in greater than a 3 
percent change in the formula.
    Response: Most of the commenters agreed with the recordkeeping 
requirements that USDA has proposed for the rule. USDA disagrees with 
the commenter who claims that the requirement to keep documentation to 
support environmental, health, sustainability benefits, life cycle 
costs, or product performance claims is outside the jurisdiction of 
USDA. Because the labeling of biobased products is voluntary, USDA 
believes that making the use of the label contingent upon keeping such 
documentation is justified and reasonable. If a labeled biobased 
product also includes such claims of product benefits without proper 
justification and documentation of the benefits, then UDSA believes 
that the integrity of the label is compromised. Thus, USDA does not 
believe that manufacturers who make such product benefit claims without 
documentation should be allowed to include the Certified Biobased 
Product label on their products.
    Regarding the commenter's concern about formulation changes, USDA's 
intent is that manufacturers must keep records of changes in the 
product formulation that result in the products biobased content 
changing. USDA has clarified the text of the recordkeeping provisions 
in the final rule to limit the recordkeeping to formulations that 
affect the biobased content of the product.

Benefits and Costs

    Comment: Three commenters agree that the benefits outweigh the 
costs of the program (e.g., testing, submitting applications and 
associated information, and recordkeeping). One of the commenters adds 
that USDA must take great care to ensure that it emphasizes the 
collection and use of complete, technically sound information on which 
to base its decisions.
    Response: The commenters generally agreed with the goals of the 
program and did not offer any specific data or suggestions that would 
necessitate any changes to the program.
    Comment: One environmental group commenter states that USDA should 
prepare an environmental impact statement (EIS) to show the 
environmental impacts of these proposed rules and alternatives. The 
commenter also states that this program should avoid creating 
incentives to transfer of large acreage from bio-diverse ``conservation 
reserve programs'' to monocropping for biobased products and that the 
consequences must be disclosed in a National Environmental Policy Act 
(NEPA) analysis.
    Response: While the commenter's concerns are appreciated, USDA 
believes that the rule complies with all regulatory requirements and 
does not agree that any additional NEPA analysis, such as an EIS, is 
also required.

Application Fee

    Comment: Three commenters state that a proposed future application 
fee of $500 is reasonable as long as the fee is allocated towards a 
certification mark auditing and/or monitoring program.
    One individual commenter states some fee is justified to help with 
implementing portions of the labeling program but that many companies 
are reluctant to participate in the BioPreferred Program because they 
are not convinced that doing so will increase product sales 
significantly. The commenter states that the economic benefits of 
participating in the BioPreferred Program are yet to be verified, so 
any fee should not exceed $500.
    One commenter does not support imposition of any future labeling 
fees that would unduly burden companies, particularly small- and 
medium-size biobased product manufacturers. An application fee could 
cause an economic burden for companies with multiple products and 
small- and medium-size companies, and discourage them from applying for 
the label. For companies with multiple products, fees can add up 
quickly and adding another $500 per product on top of the testing fees 
could put the labeling program out of reach for many companies, 
particularly small- and medium-size companies.
    Response: While most commenters support the collection of a fee, 
particularly if the proceeds from this fee supported efforts to audit/
monitor compliance with the voluntary labeling program, USDA is not 
currently authorized to impose an application fee and, thus, cannot do 
so. USDA has, however, included in today's final rule the regulatory 
text necessary to implement a $500 application fee. The effective date 
of the fee provision is pending until USDA is granted the legislative 
authority to impose the fee. A Federal Register notice will be issued 
amending the final rule to add the effective date of the application 
fee provisions once the authority is granted.

General Comments

    Comment: One environmental group states that the proposed rules 
over-generalize the benefits of biobased products and fail to recognize 
that some biobased products are more preferred than others. The 
commenter states that these rules raise the prospect of 
``greenwashing'' by potentially misleading the public into thinking 
that some products are environmentally benign when they are not benign, 
relative to existing products or alternatives.
    Response: While USDA appreciates the commenter's concerns, the 
purpose of the voluntary labeling program is to promote and increase 
the use of biobased products as defined in the rule. The labeling 
program is designed to support this goal by recognizing manufacturers 
and vendors that produce and market products that utilize biobased 
materials and by encouraging consumers outside the Federal Government 
to purchase such products. It is not USDA's intent to mislead or 
otherwise misinform the public about the potential benefits of one 
particular product over another. In addition, manufacturers and vendors 
are required to post certain information about their products on USDA's 
Web-hosted BioPreferred Program site.
    Comment: One industry organization and two industry commenters 
state that Congressional intent in enacting section 9002 was to 
stimulate the development of a value-added biobased products industry 
with a focus on expanding demand for new uses and applications. This 
purpose was made even clearer when Congress enacted the 2008 Farm Bill 
and changed the name of the section 9002 program to the ``Biobased 
Markets Program.'' To grow the market for biobased products, it is 
essential to recognize the role of the entire value chain, from 
feedstocks (e.g., soy, corn, canola, sunflowers) to intermediate 
ingredients (e.g., polyols, resins, biosolvents) to formulated products 
(e.g., cleaners, lubricants, insulation, foams, plastics) to finished 
products

[[Page 3800]]

that contain biobased components (e.g., chairs or bedding with biobased 
foam).
    One industry commenter states that the voluntary labeling program 
presents the opportunity for USDA to affect stakeholders within the 
bioproducts/biomaterials value chain and create additional market pull 
for the biobased intermediates upon which the final products are based. 
Intermediates are derived more directly from agricultural products and 
encompass the transformational technologies that enable the final 
products to have biobased content. This is the essential link in 
converting agricultural feedstock to final products. Including 
intermediates along with final products is also critical to the success 
of the BioPreferred Program.
    Response: USDA agrees with the commenters and has included 
intermediate ingredients and feedstocks in its proposed and final 
definition of ``biobased product.''

Definitions

    Comment: One industry organization commenter states that to avoid 
ambiguity, USDA should include a definition of what is considered a 
``complex product'' in the Definitions section of the rule.
    One industry organization commenter and one industry commenter 
recommend that USDA include vendors, distributors, and re-packagers 
under the definition of ``Designated Representative.'' As part of the 
application process, manufacturers could provide USDA with a list of 
the ``designated representatives'' who would be using the certification 
mark. USDA should also allow certified manufacturers to update this 
list from time to time without requiring that a new application being 
submitted. Finally, if a vendor, distributor, or re-packager is 
included as a ``Designated Representative,'' they should be held 
directly accountable by USDA for any violations in how they use the 
certification mark or any changes they make to a product's biobased 
content that violates the use of the mark. Section 2904.7 of the 
proposed rule would need to be modified to make sure that manufacturers 
are not held responsible for the way the mark is used by the vendors, 
distributors, or re-packagers that are listed as ``Designated 
Representatives.'' It is important that USDA hold the vendors, 
distributors, and re-packagers to the same standards that they will 
hold the manufacturer and use the same enforcement mechanisms against 
those entities if a violation occurs. In addition, USDA should clarify 
the definition of ``Manufacturer'' to include any ``vendor'' that 
alters a product. Such a vendor should be considered a formulator and 
formulators should be considered manufacturers.
    Two industry organization commenters state that the proposed 
labeling contains a definition of ``Intermediate Ingredients or 
Feedstocks'' that varies from the statutory definition. USDA adds the 
following language to the definition: ``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.'' 
The commenter states that USDA provides no justification for this 
additional language, the language is inconsistent with the statute, and 
it should not be included in the labeling program rule.
    Two commenters state that the proposed labeling rule's definition 
of ``Intermediate Ingredients or Feedstocks'' needs more clarity. One 
of the commenters states that all of the currently designated items 
appear to be finished products (e.g., something a consumer could buy) 
and that he does not understand how any intermediate itself could be 
identified as a BioPreferred Product (a product eligible for preferred 
Federal purchasing). The commenter asked whether polymers would be 
considered to be intermediates, since they would be converted into 
finished products which may be eligible for Federal preferred 
procurement.
    One individual commenter states that a biobased product is defined 
as a commercial or industrial product 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. The commenter believes USDA 
should consider removing part ``B'' from the definition since it is 
redundant. The commenter believes that anything falling into part B 
will also fall within the definition provided in part A.
    One commenter feels it is very important that the Agency carefully 
define what ``renewable'' means. Without a specific definition, the 
commenter felt, a surge in biobased agriculture could spawn a severe 
uptick in unsustainable agriculture, the use of genetically modified 
organisms, and toxic farming chemicals that would be even more 
polluting to the land and water. The commenter stated that this has 
already been the case with corn-based fuels and industrialized farming. 
The commenter suggests adding these definitions to the renewable 
criteria--``Bio material is (1) grown in a sustainable manner, 
including in relation to soils, waterways, forests, and animals, (2) 
does not take away from the natural biodiversity of the material in the 
wild, organic, and farmed environments, (3) does not pollute or degrade 
soils and waterways as materials are grown and managed, and (4) 
genetically modified plants should not be acceptable as renewable.''
    Response: USDA is in the process of completing a ``term 
definitions'' section on the BioPreferred Program Web site and will 
consider the various comments received on the definitions in the 
development of that section. Regarding the comment concerning the 
definition of a ``complex product'', a complex product is a finished, 
consumer product composed of many different types of components. 
Today's rule does not contain provisions to allow for the labeling of 
complex products.
    Regarding the definition of ``biobased product,'' USDA makes no 
change to this definition as it thinks it is important to point out 
that for the purposes of this subpart ``intermediate ingredients or 
feedstocks'' can meet the definition of a ``biobased product.''
    Regarding the definition of ``intermediate ingredients or 
feedstocks,'' one commenter opposed USDA's proposed addition of the 
following language to the statutory definition: ``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.'' 
USDA proposed the definition that included this sentence to clarify 
that it does not intend for the label to be used on raw, unprocessed 
agricultural or forestry materials such as corn kernels, soybeans, or 
forestry thinnings. However, once these raw materials have been 
``processed'' into feedstock materials such as corn starch, soybean 
oil, or wood fibers, they can be labeled as intermediate ingredients or 
feedstocks if they meet the other criteria for certification. USDA does 
not believe that the proposed definition is inconsistent with the 
statutory language that states that an intermediate ingredient or 
feedstock means ``* * * a material or compound made in whole or in 
significant part from biological products * * *.''

[[Page 3801]]

Criteria for Obtaining Certification

    Comment: One industry organization commenter recommends that USDA 
clarify and explicitly state whether domestic biobased carbon content 
is required. On ``Criteria for Obtaining Certification,'' biobased 
product is defined with the language ``including renewable domestic 
agricultural materials.'' The commenter states that it appears that 
domestic versus foreign source new carbon content is irrelevant in the 
label application.
    Response: The regulations implementing the biobased preference 
program under 7 CFR 2902.2 define biobased products as ``A product 
determined by USDA to be a commercial or industrial product (other than 
food or feed) that is composed, in whole or in significant part, of 
biological products or renewable domestic agricultural materials 
(including plant, animal, and marine materials) or forestry 
materials.''
    Subsequent amendments to 7 CFR 2902.4(b)(3) clarify that biobased 
products from any designated country would receive the same preference 
extended to U.S.-sourced biobased products.
    As stated in CFR 2902.4(b)(3) ``In implementing the preference 
program, Federal agencies shall treat as eligible for the preference 
biobased products from `designated countries', as that term is defined 
in section 25.003 of the Federal Acquisition Regulation, provided that 
those products otherwise meet all requirements for participation in the 
preference program.''
    Designated countries include countries that have entered into 
specific trade agreements with the United States (such as the North 
American Free Trade Agreement [NAFTA]) or offer reciprocal equal 
treatment to U.S.-sourced goods. However, manufacturers and vendors 
must register their products with USDA in order to qualify as an 
approved supplier of biobased products.
    Comment: One environmental group commenter states that an 
additional criterion should be included in the labeling evaluation. The 
commenter states that production of the biobased product should not 
result in net reduction in biological carbon storage in ecosystems such 
as forests, woodlands, rangelands, grasslands, wetlands, croplands, 
waterways, etc.
    Response: USDA appreciates the commenter's concerns but believes 
that these concerns fall outside the scope of the voluntary labeling 
program.

Criteria for Obtaining Certification--Criterion 1: Biobased Product

    Comment: One industry consultant commenter states that the USDA 
Certified Biobased Product Label implies a biobased product results in 
climate change impact reduction and energy/environmental security 
compared to non-biobased products. However, this is not backed up by a 
product life-cycle analysis.
    Response: The aims of the labeling program are to increase the 
purchase and use of sustainable biobased products while providing 
``green'' jobs and new markets for farmers, manufacturers, and vendors. 
USDA is hosting an informational BioPreferred Program Web site and 
requires manufacturers and vendors to provide relevant information 
concerning their products for posting on this site so that purchasers 
may access the information for use in making purchasing decisions.
    Comment: One environmental group commenter states that the proposed 
criteria for Biopreferred Products include: ``Renewable domestic 
agricultural materials and forestry materials.'' These criteria raise 
some important questions such as: (i) Does the word ``renewable'' 
describe just agricultural products, or also forestry materials? It 
should be clarified that renewable modifies both agriculture and 
forestry products.
    (ii) What is the definition of renewable? Products derived from 
logging mature and old-growth forests, or habitat of imperiled or 
declining species, or short-rotation logging are not renewable and 
should be excluded.
    Response: The statutory definition refers to ``biological products, 
including renewable domestic agricultural materials and forestry 
materials.'' 7 U.S.C. 8101(4). USDA considers the qualifier 
``domestic,'' as well as the qualifier ``renewable,'' to apply to both 
agricultural materials and forestry materials. The Guidelines for 
implementing the BioPreferred Program include the following definition 
for the term ``forestry materials'': ``materials derived from the 
practice of planting and caring for forests and the management of 
growing timber. Such materials must come from short rotation woody 
crops (less than 10 years old), sustainably managed forests, wood 
residues, or forest thinnings.'' Thus, products derived from mature and 
old growth forests would be excluded.

Criteria for Obtaining Certification--Criterion 2: Minimum Biobased 
Content

    Comment: One industry organization commenter states that it should 
be made clear at the beginning of the rule with a definition or in 
every criterion that biobased content is verified based on an 
analytical test (ASTM Method D6866).
    Response: USDA points out that the definition of ``biobased 
content'' in this subsection clearly states that ``For BioPreferred 
Products (products that have been identified for Federal preferred 
procurement), 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 Solid, Liquid, and Gaseous Samples Using Radiocarbon 
Analysis.''
    Comment: One industry organization commenter states that criterion 
2 seems to duplicate criterion 1. The commenter states that the term 
``significant part'' (from criterion 1) would be the same as ``at or 
above its applicable minimum biobased content'' (from criterion 2). The 
commenter states that criterion 2 needs to be more clear to distinguish 
it from criterion 1.
    Response: USDA continues to believe that it is important to retain 
the language of both Criterion 1 and Criterion 2. Criterion 1 states 
that a biobased product must be composed ``in whole or significant part 
of biological products, including renewable domestic agricultural 
materials and forestry materials; or (B) an intermediate ingredient or 
feedstock.'' Criterion 2 expands upon this criterion by further 
explaining how ``significant'' is determined for each type of product 
within the three biobased product groups: BioPreferred Products (those 
that have been identified for preferred Federal purchasing), finished 
biobased products that are not currently BioPreferred Products, and 
products that are intermediate ingredients or feedstocks that are also 
not currently recognized as BioPreferred Products.
    Comment: One industry organization commenter believes that any 
biobased claim on a product with less than 95 percent biobased content 
should not be permitted to use the ``artwork'' or certification mark. 
It may, however, state ``made with * * *'' based on the amount of 
biobased material verified in the product where the claim is being made 
(not in small print that is not readily apparent to the consumer). 
While this was partially addressed by requiring the product statement 
with the artwork, allowing the use of the artwork is misleading. This 
program will mislead consumers into thinking they are purchasing a 
biobased product that has better attributes than other products.

[[Page 3802]]

    Response: USDA continues to believe that the goal of program is to 
encourage the production and purchase of biobased products. Rather than 
being exclusionary, USDA thinks it is important to set the minimum 
biobased content for items at levels that will allow for a larger 
number of participants while maintaining meaningful standards. This 
will further the goals of the program by allowing for greater 
manufacturer and vendor participation, greater purchasing and, as a 
consequence, greater awareness of the BioPreferred Program.
    Comment: One individual commenter noted that ASTM test method D6866 
has been renamed for simplicity and to better reflect the broad 
applicability of the test method. The final rule should reflect this 
change. The title of the method is now ``Standard Test Methods for 
Determining the Biobased Content of Solid, Liquid, and Gaseous Samples 
Using Radiocarbon Analysis.''
    Response: USDA agrees with the commenter and has revised the rule 
to reflect this test method name change.

Criteria for Obtaining Certification--Criterion 2: Minimum Biobased 
Content--Products That Are Intermediate Ingredients or Feedstocks That 
Are Not Within Product Categories Identified for Federal Preferred 
Procurement

    Comment: One industry association commenter states that USDA has 
provided a definition of ``intermediate ingredients or feedstocks'' 
that varies from the statutory definition.\3\ In the proposed rule, 
USDA adds the following language to the definition, ``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.'' 
USDA provides no justification for this additional language which is 
ambiguous and should not be included in the labeling rule.
---------------------------------------------------------------------------

    \3\ The definition of ``intermediate ingredient or feedstock'' 
found in the 2008 Farm Bill is as follows: ``The term `intermediate 
ingredient or feedstock' means 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.''
---------------------------------------------------------------------------

    Response: USDA believes that the additional language does not 
change the definition in any significant way, but simply further 
clarifies USDA's intent to exclude raw agricultural or forestry 
materials from the labeling program at this time. USDA further believes 
that it is important to include this language in the regulatory text 
(i.e., the text of part 2904) rather than only presenting it in the 
preamble.
    Comment: One industry commenter states that, as proposed, the 
default minimum for intermediate ingredients and feedstocks is equal to 
the default minimum for finished products. Regardless of what the 
default minimum is in the final rule, it is still unclear how the 
minimum biobased content of a feedstock translates into the minimum 
biobased content of the final product. If the feedstock is above the 
minimum, but the finished product is below the minimum due to other 
non-biobased ingredients, would that finished product be eligible? 
Conversely, if a feedstock were below the minimum, but the finished 
product above the minimum due to other biobased ingredients, would that 
finished product be eligible for the certification mark? The commenter 
requested that USDA provide additional clarity on this matter.
    Response: The commenter asks if the feedstock is above the minimum, 
but the finished product is below the minimum due to other non-biobased 
ingredients, is the finished product eligible? No, the finished product 
in this example would not be eligible for use of the certification mark 
as the finished product would not meet the 25 percent minimum biobased 
content requirement. However, any biobased component of the finished 
product with a minimum 25 percent biobased content itself would be 
eligible for use of the mark as a biobased feedstock. Alternatively, if 
a finished product composed of several biobased feedstocks of varying 
percentages of biobased content has a biobased content in sum that 
equals or exceeds 25 percent, this finished product would be eligible 
for use of the mark, though not all of its individual components may be 
eligible.

Criteria for Obtaining Certification--Alternative Minimum Biobased 
Content Analysis

    Comment: One industry commenter agrees with the proposal to have a 
procedure whereby manufacturers, vendors, and trade associations can 
request an alternative minimum biobased content for products which are 
not within a designated category. The commenter encouraged USDA to 
ensure that this procedure be as streamlined as possible and suggested 
that leveraging the designation process may be a route to streamlining.
    One industry commenter opposes the concept of allowing 
manufacturers to apply for alternative applicable minimum biobased 
contents.
    One industry organization commenter agrees with USDA's approach to 
the establishment of alternative minimum contents for the labeling 
program. However, the commenter states that the proposed rule provides 
the opportunity to request that USDA approve an alternative to the 
default content percentage for finished products that do not fall 
within a USDA designated item category but that the proposed rule 
language does not provide this same option for intermediate ingredients 
and feedstocks. The preamble to the rule indicates that USDA intended 
that the same option be available for intermediate ingredients and 
feedstocks. The commenter strongly supports this provision for finished 
products as well as intermediate ingredients and feedstocks and 
requests that USDA correct the final rule language so the ``alternative 
applicable minimum biobased content'' provision is included for 
intermediate ingredients and feedstocks.
    Response: USDA continues to believe that offering a procedure 
whereby manufacturers, vendors, and trade associations can request an 
alternative minimum biobased content for products is in the best 
interest of the labeling program. USDA agrees with the commenter that 
the intent of the program is to allow, under consultation with USDA, an 
alternative minimum biobased content for intermediate ingredients and 
feedstocks as well as finished products that are not currently 
BioPreferred Products. USDA has revised the appropriate rule language 
(section 2904.4) to reflect this intent.

Initial Approval Process--Justification for Required Information

    Comment: One biobased industry commenter states that the proposed 
rule requires that each finished product be tested under ASTM D6866. 
The commenter states that they have eight hydraulic oils that can be 
listed under the program and each has exactly the same feedstock as the 
biobased content. The commenter recommends that they be able to certify 
in a lab per the proposed rule the common feedstock (in this case 
vegetable oil) as biobased and then be able to use that feedstock as a 
basis to calculate finished product biobased content. The commenter 
states that the number of products they have, given that many have only 
very slightly different viscosities and additives, will result in more 
testing costs than needed and cause them to carefully evaluate whether 
they should list them on the program based on the testing costs. The

[[Page 3803]]

commenter thinks this recommendation ensures the program standards are 
met and allows a low cost of participation.
    Response: USDA agrees with the commenter's recommendation and will 
allow representative content testing to suffice provided the product 
formulation does not vary more than 3 percent for multiple products 
with a common feedstock. This will facilitate manufacturers and vendors 
more rapidly and economically adding more biobased products to the 
labeling program without unnecessary regulatory obstacles.

Initial Approval Process--BEES/Life Cycle Analysis

    Comment: One industry commenter states that designated biobased 
products were required to be evaluated using life cycle assessment 
(LCA), specifically using the Building for Environmental and Economic 
Sustainability (BEES) analyses. With the BEES analyses, purchasers have 
been able to better understand the environmental impacts and aspects of 
biobased products. By undertaking BEES analyses, biobased product 
manufacturers have been able to set themselves apart from other 
manufacturers in their proactive stance toward environmental issues, 
thereby generating environmental awareness in the biobased community 
and beyond. The commenter is very concerned that the proposed labeling 
program has eliminated the requirement to perform an LCA. The commenter 
presented the following concerns:
    A. Biobased products potentially have significant impacts on 
climate change, biodiversity, food security, and many other impact 
categories. Without the application of LCA to these products, it is 
impossible to tell what actions should be pursued to make these 
products more environmentally friendly.
    B. By omitting the requirement for an LCA-based labeling program, 
USDA is losing a major opportunity toward the global competitiveness of 
U.S. Agricultural Products.
    C. USDA's proposed biobased certification mark does not follow the 
international consensus standards on Ecolabels (the ISO 14020 series) 
because it does not take environmental life cycle consideration into 
account.
    D. USDA is missing an opportunity to build overall LCA capacity and 
competitiveness in the U.S. Requiring LCAs of biobased products would 
help supply U.S. average data on their environmental impacts.
    The commenter urges USDA to reconsider the elimination of 
environmental LCAs from their biobased products labeling scheme. Its 
inclusion made the program a strong driver for sustainability and 
helped biobased American products be more competitive not only through 
Federal purchases but also in national and international markets.
    One environmental group states that the rules should reflect the 
carbon consequences of the underlying production processes, including 
long-term, life-cycle effects. The simple fact of being biobased does 
not guarantee that a product is preferred from the standpoint of 
environmental or social values. It is far better to conduct a more 
comprehensive evaluation of the life-cycle impacts of alternative 
products.
    Response: USDA has given extensive consideration to the subject of 
LCA and, specifically, the BEES analysis. This subject was the primary 
topic of a public meeting hosted by USDA in Washington, DC on January 
5, 2010 (visit the BioPreferred Program Web site to read a transcript 
of the meeting). Opinions vary widely among Federal agency personnel, 
industry representatives, members of the academic community, and the 
general public regarding the accuracy of, and the usefulness of, the 
results of these analyses. USDA is currently continuing its efforts to 
formulate a final decision on any requirements to perform LCA analyses 
on products in conjunction with the BioPreferred Program. At this time, 
USDA is performing BEES analyses on a small number of sample products 
within each product category as part of the identification of product 
categories for Federal preferred procurement. For the voluntary 
labeling program, the only requirement is that claims made by 
manufacturers regarding the environmental or life cycle benefits of 
their labeled products must be supported by appropriate documentation. 
USDA believes this requirement is a reasonable way to discourage false 
or undocumented claims on labeled products. Once USDA has made a final 
decision about the role of LCA or environmental analyses for products 
identified and certified by the BioPreferred Program, that decision and 
any associated requirements for participants in the program will be 
announced in the Federal Register with an opportunity for public 
comment.

Violations--Audit Program

    Comment: One industry organization commenter believes that USDA 
should, as proposed, implement its own audit program, with particular 
focus on ensuring that the biobased content of the products actually 
being marketed with the certification mark meet the minimum criteria. 
USDA's enforcement program should also be directed to take action 
against those who use the certification mark or create a similar label 
of their own and place it on products without the USDA biobased product 
certification. The commenter urges USDA to add explicit language to its 
proposed rule to cover violations and enforcement mechanisms for ``Use 
of the Certification Mark Without Certification,'' which would include 
using the certification mark or a facsimile or other artwork or 
statements that imply a product is a ``USDA Certified Biobased 
Product'' when it is not. In addition, USDA should work closely with 
the FTC to encourage FTC to pursue its enforcement authority against 
any stakeholder who makes misleading or false claims that state or 
imply that they have USDA certification to use the certification mark 
when they do not.
    To maintain the integrity of the mark, one industry commenter 
supports a strong and fair product audit and certification mark 
enforcement program and believes that USDA should, as proposed, 
implement its own audit program and the $500 fee suggested should be 
used to set up such program.
    One individual commenter does not believe it is a good use of 
taxpayer dollars to inspect manufacturer and vendor facilities 
(including their records, etc.) as part of a random audit program. This 
will be very costly and time consuming, at a time when the public eye 
on government waste is at a high point. The commenter states that 
simply visiting retail facilities and testing the biobased content of 
labeled products purchased from those facilities is the best way to 
conduct the audit program. That approach will address the most 
important aspects of an audit program.
    One nonprofit organization states that, as with any labeling 
program, they do not believe that affidavits from manufacturers suffice 
for label certification and that without adequate verification, testing 
and inspection that a program of this size would not be able to 
maintain integrity over time and ultimately would cloud an already 
murky green labeling marketplace.
    Response: USDA received several comments for and against the 
imposition of an auditing requirement. USDA continues to believe that 
adequate recordkeeping and auditing are necessary to ensure the 
standards of the program and will work with other agencies, as 
appropriate, to make certain that manufacturers and vendors comply with 
all labeling program regulations.

[[Page 3804]]

Violations--Other Remedies

    Comment: One government agency commenter states that, if a 
manufacturer of a labeled product were found to be in violation of the 
labeling rule requirements, USDA could supply the name of the 
manufacturer to the General Services Administration (GSA) and they 
would add the name to the Excluded Parties List. This list is checked 
by buyers as part of a responsibility determination before making an 
award, so if the manufacturer's/vendor's name is on the list, they 
would not be awarded a contract with the Federal government.
    Response: The proposed rule (at 74 FR 38316) already includes the 
penalty suggested by the commenter. It states that, in cases of 
violations, ``* * * USDA may pursue suspension or debarment of the 
entities involved in accordance with part 3017 of this title.'' As of 
the publication date of the proposed rule, part 3017 provided for the 
inclusion of a name on GSA's Excluded Parties List System once the 
party is suspended or debarred.

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 final rule has been reviewed 
under Executive Order (EO) 12866 and has been determined to be 
significant. Today's rule establishes a voluntary labeling program that 
allows manufacturers and vendors of certified biobased products to use 
the ``USDA Certified Biobased Product'' certification mark. 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 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 Program Web site, maintaining applicable 
records, and redesigning the product packaging to incorporate the 
certification mark. USDA estimates that the combined annualized cost of 
the voluntary program to manufacturers and vendors would average 
approximately $2,813,811 per 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 voluntary 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 USDA 
believes that the program is likely 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. Additional 
information regarding the primary industry sectors expected to be 
affected by today's final rule is presented under the discussion of the 
Regulatory Flexibility Act below.
2. Benefits of the Rule
    As an integral part of USDA's BioPreferred Program, the voluntary 
labeling program may 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 
value-added agricultural processing and manufacturing in rural 
communities; and to enhance the Nation's energy security by 
substituting biobased products for products derived from imported oil 
and natural gas. On a national and regional level, today's final rule 
may 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 required to prepare an initial 
regulatory flexibility analysis of any rule subject to notice and 
comment rulemaking requirements under the Administrative Procedure Act 
or any other statute unless the agency can certify that the rule will 
not have a significant economic impact on a substantial number of small 
entities, and the agency can provide a factual basis to support the 
certification. Based upon its assessment of the projected impact of 
this rulemaking, USDA certifies that the rule will not have a 
significant economic impact on a substantial number of small entities.
    Small entities include small businesses, small organizations, and 
small governmental jurisdictions. 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 (SBA) 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.
    To assess the potential effects of this rulemaking on small 
businesses, USDA conducted a review of U.S. Census Bureau data compiled 
by the Small Business Administration's (SBA) Office of Advocacy. USDA 
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. USDA 
then used the Census Bureau data to determine the number of small 
businesses in those categories and the average total receipts for those 
businesses. This data and the associated analysis was valuable in 
determining whether the rulemaking would have a significant economic 
impact on a substantial number of small businesses. Based upon the data 
and accompanying analysis, USDA identified 2,493 small businesses in 
the six identified manufacturing categories. The total receipts for 
these small businesses averaged $11.4 million. USDA will note, however, 
that this average receipt data does not convey the differences between 
certain manufacturing categories, such as those reflected between the 
plastics materials and carpet manufacturing sectors. Additional 
information supporting USDA's analysis is available in the following 
table. USDA requests comments on the quality of this analysis and ways 
to improve it.

[[Page 3805]]



----------------------------------------------------------------------------------------------------------------
                                                                                                  Average small
                                                                  Number  of   Small business       business
                        NAICS category *                            small      total receipts    receipts ($ in
                                                                  businesses  ($ in thousands)     thousands)
----------------------------------------------------------------------------------------------------------------
Petroleum lubricating oil and grease manufacturing.............          261         3,354,088         12,850.91
Plastics material and resin manufacturing......................          475        10,929,491         23,009.45
Soap and other detergent manufacturing.........................          623         5,351,973          8,590.65
Urethane and other foam product (except polystyrene)                     413         2,815,231          6,816.54
 manufacturing.................................................
Carpet and rug mills manufacturing.............................          258         1,733,880          6,720.47
Fertilizer manufacturing.......................................          463         4,133,533          8,927.72
----------------------------------------------------------------------------------------------------------------
* Information provided in this table is available on the SBA's Office of Advocacy Web site and was derived from
  the U.S. Census Bureau's 2007 Survey of Business Owners. The information can be found at: http://www.sba.gov/advo/research/data.html#susb.

    Census Bureau data on firm size also indicates that, collectively, 
more than 91 percent of the firms in the six categories meet the SBA 
definition of small business. Despite the high percentage of program 
participants that will be small businesses, the total number of small 
businesses affected by this rulemaking will not be substantial. USDA 
estimates that 352 manufacturers and vendors will apply to participate 
in the program annually. That number would represent around 14 percent 
of the total small businesses identified in the six NAICS categories 
identified above. The 14 percent figure can likely be further reduced 
when considering that the six NAICS categories represent only product 
manufacturing and not product vendors. In addition, the 352 
manufacturers and vendors cited above does not reflect solely small 
businesses since large businesses will also be eligible to participate 
in the program.
    The benefit-cost analysis USDA conducted for the rule, discussed in 
Section VI.A.1. above, indicates that the annualized cost associated 
with participating in the voluntary labeling program is about $7,994 on 
average and, relative to total receipts by small businesses in the 
NAICS categories where many biobased products are manufactured, appears 
not to represent an undue burden in most cases.
    In some cases, however, where a small business may experience a 
burden of conducting multiple biobased content tests as a result of 
manufacturing multiple biobased products, USDA has decided to reduce 
the testing burden. As indicated earlier in the preamble of this rule, 
USDA has agreed to allow representative product testing for products 
with a similar formulation. This allowance should further reduce any 
undue burden faced by small businesses participating in the program.
    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 certification mark 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 Program 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.

C. Executive Order 12630: Governmental Actions and Interference With 
Constitutionally Protected Property Rights

    This 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 rule does not have sufficient federalism implications to 
warrant the preparation of a Federalism Assessment. Provisions of this 
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 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 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 rule does not significantly or uniquely affect the 
communities of Indian tribal governments. The 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 through 3520), the information collection provisions associated 
with this final rule have been submitted to the Office of Management 
and Budget (OMB) for approval as a new collection and assigned OMB 
number 0503-XXXX. In the publication of the proposed rule on July 31, 
2009, USDA solicited comments on the estimated burden. USDA received no 
public comment letters in response to this solicitation. This 
information collection requirement will not become effective until 
approved by OMB. Upon approval of this information collection, USDA 
will publish a notice in the Federal Register.

I. E-Government Act Compliance

    USDA is committed to compliance with the E-Government Act to 
promote the use of the Internet and other information technologies to 
provide increased opportunities for citizen access to government 
information and services, and for other purposes. For

[[Page 3806]]

information pertinent to E-Government Act compliance related to this 
rule, please contact Ron Buckhalt at (202) 205-4008.

J. Small Business Regulatory Enforcement Fairness Act

    The 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.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, that includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. USDA has submitted a report containing this rule and 
other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register.

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) is amending 7 CFR chapter XXIX as follows:

CHAPTER XXIX--OFFICE OF ENERGY, DEPARTMENT OF AGRICULTURE

0
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 certification 
mark.
2904.5 Initial approval process.
2904.6 Appeals process.
2904.7 Requirements for the use of the certification mark.
2904.8 Violations.
2904.9 Recordkeeping requirements.
2904.10 Oversight and monitoring.

    Authority: 7 U.S.C. 8102.

PART 2904--VOLUNTARY LABELING PROGRAM FOR BIOBASED PRODUCTS


Sec.  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'' 
certification mark. 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'' mark 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 certification. In addition, this 
part establishes specifications for the correct and incorrect uses of 
the certification mark, which apply to manufacturers, vendors, and 
other entities. Finally, this part establishes actions that constitute 
voluntary labeling program violations.


Sec.  2904.2  Definitions.

    Applicable minimum biobased content. The biobased content at or 
above the level set by USDA to qualify for use of the certification 
mark.
    ASTM International (ASTM). American Society for Testing and 
Materials is 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 BioPreferred Products (products 
that have been identified for Federal preferred procurement), 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 Solid, 
Liquid, and Gaseous Samples Using Radiocarbon 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.
    BioPreferred Product. A biobased product that meets or exceeds 
minimum biobased content levels set by USDA, and that is found within 
any of the product categories that have been identified, in subpart B 
of 7 CFR part 2902, whose products within are eligible for Federal 
preferred procurement/purchasing.
    Certification mark. A combination of the certification mark artwork 
(as defined in this subpart); one of three statements identifying 
whether the USDA certification applies to the product, the package, or 
both the product and package; and, where applicable, the letters ``FP'' 
to indicate that the product is within a designated product category 
and eligible for Federal preferred procurement. The certification mark 
is owned, and its use is managed by, USDA (standard trademark law 
definition applies).
    Certification mark artwork. The distinctive image, as shown in 
Figures 1-3, that identifies products as USDA Certified.

[[Page 3807]]

[GRAPHIC] [TIFF OMITTED] TR20JA11.000

[GRAPHIC] [TIFF OMITTED] TR20JA11.001


[[Page 3808]]


    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'' 
certification mark.
    Days. As used in this part means calendar days.
    Designated item. For the purposes of this part means product 
categories (generic groupings of products that perform the same 
function) within which the products have been afforded a procurement 
preference by Federal agencies under the BioPreferred Program. These 
BioPreferred Products have been identified for Federal 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 certification mark to the manufacturer's or 
vendor's certified biobased product or its packaging.
    Intermediate ingredients or feedstocks. Materials or compounds 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.
    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 
Federal preferred procurement or labeling as defined under subpart B of 
part 2902 of this title because they had significant national market 
penetration in 1972.
    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'' 
certification mark 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.


Sec.  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.
    (b) Other entities. The requirements in this part apply to other 
entities who wish to use the certification mark in promoting the sales 
or the public awareness of certified biobased products.


Sec.  2904.4  Criteria for product eligibility to use the certification 
mark.

    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. The product for which certification is sought 
must be a biobased product as defined in Sec.  2904.2 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) BioPreferred Products.
    (i) Product is within a single product category. If the product is 
within a single product category that, at the time the application for 
certification is submitted, has been designated by USDA for Federal 
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.
    (ii) Product is within multiple product categories. If a biobased 
product is marketed within more than one product category identified 
for preferred Federal purchasing, uses the same packaging for each 
product, 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 product categories in order 
to use the certification mark on the product. However, if the 
manufacturer packages the product differently for each product 
category, then the applicable minimum biobased contents are those 
established under paragraph (b)(1)(i) of this section for each product 
category for which the applicant seeks to use the certification mark.
    (2) Finished biobased products that are not BioPreferred Products.
    (i) If the product is not an intermediate ingredient or feedstock, 
and is not within a product category eligible for Federal preferred 
procurement at the time the application for certification is submitted, 
the applicable minimum biobased content is 25 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 to be labeled.
    (ii) If a product certified under paragraph (b)(2)(i) of this 
section is within a product category that USDA subsequently designates 
for Federal 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.
    (3) Products that are intermediate ingredients or feedstocks.
    (i) If the product is an intermediate ingredient or feedstock that 
is not eligible for Federal preferred procurement at the time the 
application for certification is submitted, the applicable minimum 
biobased content is 25 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.

[[Page 3809]]

If approved by USDA, the proposed alternative applicable minimum 
biobased content would become the applicable minimum biobased content 
for the intermediate ingredient or feedstock product to be labeled.
    (ii) If a product certified under paragraph (b)(3)(i) of this 
section is within a category that USDA subsequently designates for 
Federal 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.


Sec.  2904.5  Initial approval process.

    (a) Application. Manufacturers and vendors seeking USDA approval to 
use the certification mark for an eligible biobased product must submit 
a USDA-approved application for each biobased product. A standardized 
application form and instructions are available on the USDA 
BioPreferred Program Web site (http://www.biopreferred.gov). The 
contents of an acceptable application are as specified in paragraphs 
(a)(1) through (a)(4) 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 documentation, intended uses, 
and, if applicable, the corresponding product category classification 
for Federal preferred procurement. The applicant must attach to the 
application documentation demonstrating that the reported biobased 
content was tested by a third-party testing entity that is ISO 9001 
conformant.
    (2) Certifications. The applicant must certify in the application 
that the product for which use of the certification mark is sought is a 
biobased product as defined in Sec.  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 (c)(4) of this 
section, which USDA will post to the USDA BioPreferred Program Web 
site, and to providing USDA with up-to-date information for posting on 
this Web site.
    (4) Application fee. Effective (date to be added after authority to 
collect fee is granted), applicants must submit an application fee of 
$500 with each completed application for certification. Instructions 
for submitting the application fee are available on the USDA 
BioPreferred Program Web site (http://www.biopreferred.gov), along with 
the application form and instructions.
    (b) Evaluation of applications. (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 Sec.  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 certification mark 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 
Sec.  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 Program Web site) 
the information specified in paragraphs (c)(1) through (c)(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 certification mark on the certified biobased product.
    (1) The product's brand name(s), or other identifying information.
    (2) Contact information, including the name, mailing address, email 
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 (d)(2)(i) through (d)(2)(iii) of this section, 
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 certification 
mark to the product and must not initiate any further advertising of 
the product using the certification mark. 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, the existing certification 
will continue to be valid for the product.
    (iii) If the applicable required minimum biobased content for a 
product to be eligible to display the certification mark 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 certification mark. Manufacturers and vendors 
who have re-applied for certification may continue using the existing 
certification mark until they receive notification from USDA on the 
results of their re-application for certification.

[[Page 3810]]

Sec.  2904.6  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.
    (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 361, 
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, vendor, and their 
designated representative(s) may immediately resume affixing the 
certification mark to the certified biobased product and USDA will 
reinstate the product's information to the USDA BioPreferred Program 
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 
certification mark to the certified biobased product and sell and 
distribute the certified biobased product with the certification mark. 
In addition, USDA will reinstate the product's information to the USDA 
BioPreferred Program Web site.
    (c) 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 certification 
mark on that product, as specified in Sec.  2904.5(a) of this part.
    (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.


Sec.  2904.7  Requirements associated with the certification mark.

    (a) Who may use the certification mark?
    (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 official certification 
mark (in one of the three variations, as applicable) 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 certification mark on the product, its packaging, 
and other related materials including, but not limited to, 
advertisements, catalogs, specification sheets, 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 mark is used by its 
companies, as well as its designated representatives, including 
advertising agencies, marketing and public relations firms and 
subcontractors.
    (2) Other entities.
    (i) Other entities may use the mark to advertise or promote 
certified biobased 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 mark to the product or its packaging.
    (ii) Other entities may use the certification mark; the phrase 
``USDA Certified Biobased Product/Package/Product & Package,'' as 
applicable; 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 non-certified biobased product is certified.
    (b) Correct usage of the certification mark.
    (1) The certification mark can be affixed only to certified 
biobased products and their associated packaging.
    (2) The certification mark 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 certification mark may be used in advertisements for 
both certified biobased products and non-certified/labeled products if 
the advertisement clearly indicates which products are certified/
labeled. Care must be taken to avoid implying that any non-certified 
products are certified.
    (3) The certification mark may be used without reference to a 
specific certified biobased product only when informing the public 
about the purpose of the certification mark. For example, the following 
or similar claim is acceptable: ``Look for the `USDA Certified Biobased 
Product' certification mark. 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 to be posted on 
the USDA BioPreferred Program Web site.'' This exception allows 
manufacturers, vendors, and other entities to use the certification 
mark in documents such as corporate reports, but only in an informative 
manner, not as a statement of product certification.
    (4) The certification mark may appear next to a picture of the 
product(s) or text describing it.
    (5) The certification mark must stand alone and not be incorporated 
into any other certification mark or logo designs.
    (6) The certification mark 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 certification mark must be written in 
English and may not be translated, even when the certification mark is 
used outside of the United States.
    (c) Incorrect usage of the certification mark.
    (1) The certification mark shall not be used on any product that 
has not been certified by USDA as a ``USDA Certified Biobased 
Product.''
    (2) The certification mark 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 
certification mark applies to only the certified biobased product(s).
    (3) The certification mark shall not be used to imply endorsement 
by USDA or the BioPreferred Program of any particular product, service, 
or company.
    (4) The certification mark shall not be used in any form that could 
be misleading to the consumer.
    (5) The certification mark shall not be used by manufacturers or 
vendors of

[[Page 3811]]

certified products in a manner disparaging to USDA or any other 
government body.
    (6) The certification mark shall not be used with an altered 
certification mark or incorporated into other label or logo designs.
    (7) The certification mark shall not be used on business cards, 
company letterhead, or company stationery.
    (8) The certification mark 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 certification mark shall not be used in a manner that 
violates any of the applicable requirements contained in this part.
    (d) Imported products. The certification mark can be used only with 
a product that is certified by USDA under this part. The certification 
mark 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/Package/Product & Package'' must have received 
certification from USDA.
    (e) Contents of the certification mark. The certification mark 
shall consist of the certification mark artwork, the biobased content 
percentage, and one of the three variations of text specified in 
paragraphs (e)(1) through (e)(3) of this section, as applicable.
    (1) USDA Certified Biobased Product.
    (2) USDA Certified Biobased Product: Package.
    (3) USDA Certified Biobased Product & Package.
    (f) Physical aspects of the certification mark. The certification 
mark artwork may not be altered, cut, separated into components, or 
distorted in appearance or perspective. Certification marks that are 
applied to biobased products that have been designated for preferred 
Federal procurement will include the letters ``FP'' as part of the 
certification mark artwork. The certification mark must appear only in 
the colors specified in paragraphs (f)(1) through (f)(3) of this 
section, unless approval is given by USDA for an exception.
    (1) A multi-color version of the certification mark is preferred. 
The certification mark colors to be applied will be stipulated in the 
``Marketing Guides'' document available on the USDA BioPreferred 
Program Web site (http://www.biopreferred.gov).
    (2) A one-color version of the certification mark may be 
substituted for the multi-color version as long as the one color used 
is one of the multi-color choices reapplied without modification. 
Further guidance on the one-color certification mark application will 
also be detailed in the ``Marketing Guides.''
    (3) A black and white version of the certification mark is 
acceptable.
    (g) Placement of the certification mark.
    (1) The certification mark 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 certification mark 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 certification mark must appear near a picture of the 
product or the text describing it.
    (i) If all products on a page are certified biobased products, the 
certification mark may be placed anywhere on the page.
    (ii) If a page contains a mix of certified biobased products and 
non-certified products, the certification mark shall be placed in close 
proximity to the certified biobased products. An individual 
certification mark near each certified biobased product may be 
necessary to avoid confusion.
    (h) Minimum size and clear space recommendations for the 
certification mark.
    (1) The certification mark may be sized to fit the individual 
application as long as the correct proportions are maintained and the 
certification mark remains legible.
    (2) A border of clear space must surround the certification mark 
and must be of sufficient width to offset it from surrounding images 
and text and to avoid confusion. If the certification mark's color is 
similar to the background color of the product or packaging, the 
certification mark in a contrasting (i.e., black, white) color may be 
used.
    (i) Where to obtain copies of the certification mark artwork. The 
certification mark artwork is available at the USDA BioPreferred 
Program Web site http://www.biopreferred.gov.


Sec.  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 Sec.  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 Sec.  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 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 90 days from receipt of USDA written notification, a new 
application for the lower biobased content. Failure to submit a new 
application within 90 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) Certification mark violations.
    (i) Any usage or display of the certification mark that does not 
conform to the requirements specified in Sec.  2904.7.

[[Page 3812]]

    (ii) Affixing the certification mark to any product prior to 
issuance of a notice of certification from USDA.
    (iii) Affixing the certification mark 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 Program 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. USDA will first 
issue a preliminary notice that apparent violations have been 
identified. If satisfactory resolution of the apparent violation is not 
reached within 30 days from receipt of the preliminary notice, USDA 
will issue a notice of violation. Entities who receive a notice of 
violation for a biobased content violation must correct the 
violation(s) within 90 days from receipt of the notice of violation. 
Entities who receive a notice of violation for other types of 
violations also must correct the violation(s) within 90 days from 
receipt of the notice of violation. If the entity receiving a notice of 
violation is a manufacturer, a vendor, 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 Sec.  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 90 days 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 certification mark 
to any of that product, or associated packaging, not already labeled 
and must not distribute any additional products bearing the 
certification mark. USDA will both remove the product information from 
the USDA BioPreferred Program Web site and actively communicate the 
product suspension to buyers in a timely and overt manner.
    (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 certification mark. USDA will also 
restore the product information to the USDA BioPreferred Program 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 designated representatives must not affix the certification mark 
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 certification 
mark is affixed.
    (iii) If a manufacturer or vendor whose product certification has 
been revoked wishes to use the certification mark, 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 7 CFR part 3017. 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.


Sec.  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 (a)(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 that affect the biobased content 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 certification mark). Records may be kept in 
either electronic format or hard copy format. All records kept in 
electronic format must be readily accessible, and/or provided by 
request during a USDA audit.


Sec.  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 product labeling 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 
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 Sec.  
2904.8(b)(1) to ensure compliance with this Part.
    (c) Inspection of records. Manufacturers, vendors, and their 
designated representatives must allow Federal representatives access to 
the records required under Sec.  2904.9 for

[[Page 3813]]

inspection and copying during normal Federal business hours.

    Dated: January 10, 2011.
Pearlie S. Reed,
Assistant Secretary for Administration, U.S. Department of Agriculture.
[FR Doc. 2011-968 Filed 1-19-11; 8:45 am]
BILLING CODE 3410-39-P


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