38296 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Proposed Rules 

1The term ‘‘designated item’’ refers to items 

(generic groupings of specific products that perform 

the same function) that have been afforded 

preferred procurement by Federal agencies under 

the BioPreferred Program. 

DEPARTMENT OF AGRICULTURE 

7 CFR Part 2904 

RIN 0503–AA35 

Voluntary Labeling Program for 

Biobased Products 

AGENCY: Departmental Administration, 

USDA. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The U.S. Department of 

Agriculture (USDA) is proposing to 

establish a voluntary labeling program 

for biobased products under section 

9002 of the Farm Security and Rural 

Investment Act of 2002, as amended by 

the Food, Conservation, and Energy Act 

of 2008. Under the proposed labeling 

program, a biobased product, after being 

certified by USDA, could be marketed 

using the ‘‘USDA Certified Biobased 

Product’’ label. The presence of the 

label will mean that the product meets 

USDA standards for the amount of 

biobased content and that the 

manufacturer or vendor has provided 

relevant information on the product for 

the USDA BioPreferred Web site. The 

proposed rule applies to manufacturers 

and vendors who wish to participate in 

the voluntary labeling program. The 

proposed rule also applies to other 

entities (e.g., trade associations) that 

wish to use the label to promote 

biobased products. 

DATES: USDA will accept public 

comments on this proposed rule until 

September 29, 2009. 

ADDRESSES: You may submit comments 

by any of the following methods. All 

submissions received must include the 

agency name and Regulatory 

Information Number (RIN). The RIN for 

this rulemaking is 0503–AA35. Also, 

please identify submittals as pertaining 

to the ‘‘Proposed Voluntary Labeling 

Program.’’ 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail/commercial/hand delivery: 

Mail or deliver your comments to: Ron 

Buckhalt, USDA, Office of the Assistant 

Secretary for Administration, Room 342, 

Reporters Building, 300 Seventh Street, 

SW., Washington, DC 20024. 

• Persons with disabilities who 

require alternative means for 

communication for regulatory 

information (Braille, large print, 

audiotape, etc.) should contact the 

USDA TARGET Center at (202) 720– 

2600 (voice) and (202) 690–0942 (TTY). 

You may also send comments on the 

information collection aspects of this 

rule directly to the Office of Information 

and Regulatory Affairs of OMB, 

Attention: Desk Officer for Agriculture, 

Margaret Malanoski, 725 17th Street, 

NW., Room 10202, Washington, DC 

20503. Comments should reference 

OMB control number 0503–NEW. 

FOR FURTHER INFORMATION CONTACT: Ron 

Buckhalt, USDA, Office of the Assistant 

Secretary for Administration, Room 342, 

Reporters Building, 300 Seventh Street, 

SW., Washington, DC 20024; e-mail: 

biopreferred@usda.gov; phone (202) 

205–4008. Information regarding the 

Federal Procurement Program of 

Biobased Products (one part of the 

BioPreferred Program) is available on 

the Internet at http:// 

www.biopreferred.gov. 

SUPPLEMENTARY INFORMATION: The 

information presented in this preamble 

is organized as follows: 

I. Background 

A. Authority 

B. Overview of Section 9002 

II. Purposes of the Voluntary Labeling 

Program 

III. Voluntary Labeling Program 

A. Applicability 

B. Criteria for Obtaining Certification 

C. Initial Approval Process 

D. Appeals 

E. Information Posted on Web Site 

F. Applications for Reformulated Products 

G. Requirements Associated With the Label 

H. Violations 

I. Recordkeeping Requirements 

J. Reporting 

IV. Suggested Comment Topics 

V. Regulatory Information 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Regulatory Flexibility Act (RFA) 

C. Executive Order 12630: Governmental 

Actions and Interference With 

Constitutionally Protected Property 

Rights 

D. Executive Order 13132: Federalism 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12372: 

Intergovernmental Review of Federal 

Programs 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

H. Paperwork Reduction Act 

I. Government Paperwork Elimination Act 

Compliance 

J. Small Business Regulatory Enforcement 

Fairness Act 

I. Background 

A. Authority 

The voluntary labeling program for 

biobased products is proposed under 

the authority of section 9002 of the 

Farm Security and Rural Investment Act 

of 2002 (FSRIA)(referred to in this 

preamble as ‘‘section 9002’’), as 

amended by the Food, Conservation, 

and Energy Act of 2008 (FCEA), 7 U.S.C. 

8102. 

B. Overview of Section 9002 

Section 9002 establishes a program for 

the Federal procurement of biobased 

products by Federal agencies and a 

voluntary program for the labeling of 

biobased products. These two programs, 

which are referred to collectively by 

USDA as the BioPreferredSM Program, 

are briefly discussed below. 

Federal Procurement of Biobased 

Products. Section 9002 requires Federal 

agencies to develop procurement 

programs that give preference to the 

purchase of biobased products (hereafter 

referred to in this Federal Register 

notice as the ‘‘preferred procurement 

program’’). Federal agencies and their 

contractors are required to purchase 

biobased products, as defined in 

regulations implementing the statute, 

that are within designated items 1 when 

the cumulative purchase price of the 

procurement item(s) procured is more 

than $10,000 or when the quantities of 

functionally equivalent items purchased 

over the preceding fiscal year equaled 

$10,000 or more. Each Federal agency 

and contractor must procure biobased 

products at the highest content levels 

within each designated item unless the 

agency determines that the items are not 

reasonably available, fail to meet 

applicable performance standards, or 

are available only at an unreasonable 

price. 

The final guidelines for the preferred 

procurement program were published in 

the Federal Register on January 11, 

2005 (70 FR 1792). The guidelines are 

contained in 7 CFR part 2902, 

‘‘Guidelines for Designating Biobased 

Products for Federal Procurement.’’ 

Part 2902 is divided into two 

subparts, ‘‘Subpart A—General,’’ and 

‘‘Subpart B—Designated Items.’’ Subpart 

A addresses the purpose and scope of 

the guidelines and their applicability, 

provides guidance on product 

availability and procurement, defines 

terms used in part 2902, and addresses 

affirmative procurement programs and 

USDA funding for testing. Subpart B 

identifies designated items and specifies 

their minimum biobased contents, the 

effective date of the procurement 

preference for biobased products within 

each designated item, and other 

information (e.g., biodegradability). 

USDA is responsible for designating 

biobased items at the highest practicable 

biobased content levels for the Federal 

agencies’ preferred procurement 

programs. 


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As part of the preferred procurement 

program, section 9002 also requires 

USDA to provide information to Federal 

agencies on the availability, relative 

price, performance, and environmental 

and public health benefits of products 

within such items and, as applicable 

under section 9002(e)(1)(C), to 

recommend the minimum level of 

biobased content to be contained in the 

products within a designated item. 

To date, USDA has designated 33 

items used in a variety of applications, 

including cafeteria ware, personal and 

institutional cleaning products, 

construction products, and lubricants 

and greases. 

Voluntary Labeling Program. Section 

9002 also requires USDA to establish a 

voluntary labeling program under which 

USDA authorizes manufacturers and 

vendors of biobased products to use a 

‘‘USDA Certified Biobased Product’’ 

label (hereafter referred to in this 

preamble as ‘‘the label’’). The voluntary 

labeling program is intended to 

encourage the purchase and use of 

biobased products by reaching beyond 

the Federal purchasing community and 

promoting the purchase of biobased 

products by the general public. In 

establishing this program, USDA must 

identify the criteria to determine those 

products on which the label may be 

used and must develop specific 

requirements for how the label can be 

used. It is USDA’s intent that the 

presence of the label on a product will 

mean that the labeled product is one for 

which credible factual information is 

available as to the biobased content, 

consistently measured across labeled 

products by use of the ASTM 

radioisotope test D6866. 

In developing the proposed voluntary 

labeling program, USDA held 

discussions with other agencies that 

have implemented labeling programs, 

such as the ‘‘ENERGY STAR®’’ program 

implemented by the U.S. Department of 

Energy and the U.S. Environmental 

Protection Agency (EPA). USDA has 

also consulted with representatives of 

the Department of Agriculture’s 

National Organic program and others of 

the Agricultural Marketing Service. 

Further, USDA consulted the Federal 

Trade Commission, which issues the 

‘‘Guides for the Use of Environmental 

Marketing Claims’’ to ensure that the 

provisions of the proposed voluntary 

labeling program were consistent with 

the Guides. USDA also held a public 

meeting on July 22, 2008, to seek input 

on the content and use of the label from 

the public and industry stakeholders. 

The following section of the preamble 

presents the goal of the voluntary 

labeling program and the objectives 

toward achieving that goal. That section 

is followed by a summary of the 

voluntary labeling program that USDA 

is proposing to implement under section 

9002(h). 

II. Goal of the Voluntary Labeling 

Program 

USDA’s goal in proposing this 

voluntary labeling program is to 

encourage the increased use of biobased 

products in all market sectors. To 

achieve this goal, USDA has identified 

the following objectives: 

Promotion of biobased products. The 

voluntary labeling program is intended 

to promote and increase the use of 

biobased products. In general, the 

labeling program supports this goal by 

recognizing manufacturers and vendors 

that produce and market products that 

utilize biobased materials and by 

encouraging consumers to purchase 

such products. 

Whereas the preferred procurement 

program is specific to Federal agencies, 

the voluntary labeling program is 

intended to encompass all individuals 

and organizations making purchasing 

decisions. We are proposing that there 

be two slightly different versions of the 

label, one for those biobased products 

that have been designated for Federal 

preferred procurement because they are 

within a designated item, and another 

for those products that are not within a 

designated item. The label artwork for 

products within designated items would 

include the letters ‘‘FP’’ to indicate that 

they are Federally preferred. USDA 

believes that informing consumers that 

these products have been designated for 

Federal preferred procurement will be 

beneficial. As part of the process of 

designating items for preferred 

procurement, USDA gathers and 

evaluates information regarding the 

biobased product’s life cycle costs and 

environmental performance as well as 

functional performance. Thus, the ‘‘FP’’ 

on the label will inform consumers that 

USDA has evaluated representative 

products within the designated item and 

found them to be qualified for the 

Federal preferred procurement program. 

USDA also notes that the identification 

of products that have been designated 

for preferred procurement would also be 

accomplished by listing those products 

on the USDA Web site and in Federal 

procurement catalogues. 

Furthermore, the voluntary labeling 

program will increase the amount of 

information available to manufacturers 

whose products may utilize biobased 

materials or products as a component of 

their finished products or as part of 

their manufacturing process. USDA 

expects that this increased information 

will encourage these manufacturers to 

consider using and/or increasing the 

amount of biobased materials when 

designing or manufacturing their 

products, thereby further increasing the 

purchase of biobased materials. For 

example, manufacturers of equipment 

that uses hydraulic fluids are 

encouraged to consider the use of 

biobased hydraulic fluids if available 

information indicates that the 

performance of these fluids meets or 

exceeds their requirements. 

Increase public awareness of biobased 

products. The voluntary labeling 

program will raise the visibility of 

biobased products within the Federal 

government and within the commercial 

marketplace. The labeling program will 

also provide a unique and identifiable 

designator recognized in the U.S. and 

foreign markets. 

To the extent that the voluntary 

labeling program achieves these 

objectives, there may be an increased 

purchase of biobased products, which is 

then expected to reduce petroleum 

consumption, increase the use of 

renewable resources, better manage the 

carbon cycle, and, may contribute to 

reducing adverse environmental and 

health impacts. The program is also 

expected to promote economic 

development for biobased product 

manufacturers and vendors by creating 

new jobs and providing new markets for 

farm commodities. 

III. Voluntary Labeling Program 

In developing the voluntary labeling 

program, USDA has one primary goal— 

to encourage the purchase of biobased 

products. In implementing this goal, 

USDA aims to ensure that only biobased 

products that meet the criteria set forth 

in the voluntary labeling program are 

labeled with the ‘‘USDA Certified 

Biobased Product’’ label and that the 

label is used properly. USDA believes 

that products carrying the label will 

become readily recognizable as biobased 

products, distinct from those that do not 

carry the label. Further, as the label will 

have the percent of biobased material 

printed on it, consumers will recognize 

that products carrying the label meet 

certain criteria that set them apart from 

other products. 

A. Applicability 

The proposed rule would apply to 

manufacturers and vendors of biobased 

products, as well as to other entities 

(e.g., trade associations, public interest 

groups) that promote, sell, or use the 

products. USDA believes that each of 

these groups must comply with the 

labeling requirements in order to ensure 

that only certified biobased products 


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(i.e., biobased products that have been 

approved for use of the label under this 

program) carry the label and that the 

label is used correctly. USDA believes 

that the goals of the voluntary labeling 

program can be achieved, and the 

beneficial impacts of the BioPreferred 

program can be increased, if 

manufacturers, vendors, and other 

entities are allowed to market and 

promote the manufacturers’ biobased 

products with a credible biobased 

products labeling program. 

Once USDA has approved a biobased 

product for labeling by its manufacturer 

or vendor, an equally important aspect 

in ensuring the integrity of the labeling 

program is the proper use of the label. 

Label misuse can occur at the 

manufacturer level (e.g., affixing the 

label to a non-certified biobased 

product) and at the retail level (e.g., 

using the label to imply that a noncertified biobased product has been 

certified), or by other entities wishing to 

use the label in promoting the sales or 

public awareness of non-certified 

biobased products (e.g., on a Web site or 

in promotional materials). 

While the labeling of biobased 

products is voluntary, manufacturers, 

vendors, and other entities wishing to 

use the label in their marketing, 

promotional, or educational efforts 

would be required to comply with 

regulatory requirements as proposed 

herein. USDA believes these 

requirements for use of the label are 

necessary to avoid misleading 

consumers regarding whether a product 

has been certified by USDA under the 

voluntary labeling program. 

B. Criteria for Obtaining Certification 

To be eligible for USDA certification 

to use the label, USDA proposes that a 

product meet two criteria, as discussed 

below. 

Criterion 1: Biobased Product. The 

product must be a biobased product. 

Biobased product is defined in section 

2904.2 of today’s proposed rule as 

follows: ‘‘The term ‘biobased product’ 

means a product determined by the 

Secretary to be a commercial or 

industrial product (other than food or 

feed) that is—(A) composed, in whole or 

in significant part, of biological 

products, including renewable domestic 

agricultural materials and forestry 

materials; or (B) an intermediate 

ingredient or feedstock. For the 

purposes of this subpart, the term 

‘biobased product’ does not include 

motor vehicle fuels, heating oil, 

electricity produced from biomass, or 

any mature market products. Products 

from a mature market will be 

determined on a case-by-case basis.’’ 

Rationale for Criterion 1: As 

discussed earlier, section 9002 requires 

USDA to establish a voluntary labeling 

program under which USDA authorizes 

manufacturers and vendors of biobased 

products to use a ‘‘USDA Certified 

Biobased Product’’ label. USDA is 

proposing that mature market products 

not be eligible to use the label except on 

a case-by-case basis. Mature market 

products are those biobased products 

that had significant national market 

penetration in 1972. Examples of mature 

market products include cotton shirts or 

towels, paper plates, and wood 

furniture. USDA has excluded mature 

market products from the Federal 

preferred procurement program. In 

USDA’s explanation for excluding 

mature market products from the 

preferred procurement program, USDA 

stated in the preamble to the final 

Guidelines (70 FR 1802), ‘‘The intent of 

section 9002, as described in the 

conference report accompanying FSRIA, 

‘is to stimulate the production of new 

biobased products and to energize 

emerging markets for those products.’ ’’ 

Based on conference report, it is clear 

that Congress did not intend for mature 

market products to be given Federal 

procurement preference. It is not clear, 

however, whether this exclusion of 

mature market products was intended to 

apply to the voluntary labeling program. 

The procurement preference program 

and the labeling program are contained 

in different paragraphs of the statute, 

and the conference report does not 

specifically state whether the language 

quoted above refers to just one or to 

both paragraphs. 

USDA believes, however, that the 

widespread labeling of mature market 

products could negatively impact the 

entry of new biobased products into 

market segments in which mature 

products already have significant 

market shares. Thus, USDA believes 

that it is reasonable to exclude many 

mature market products from the 

labeling program, as it has done for the 

preferred procurement program. USDA 

is, however, proposing to allow 

manufacturers of mature market 

products to appeal (on a case-by-case 

basis) the exclusion of their products 

from the program. 

Criterion 2: Minimum Biobased 

Content. For a biobased product to 

receive certification under this proposed 

rule, the biobased content of that 

product must be at or above its 

applicable minimum biobased content, 

as described below. USDA believes this 

requirement is necessary so that the 

label is not used to promote products 

with de minimis biobased content. As 

discussed below, the applicable 

minimum biobased content depends 

under which of the three proposed 

categories the product falls. 

1. Biobased products within one or 

more designated items. If a biobased 

product (including an intermediate 

ingredient or feedstock) is within a 

designated item at the time of 

submitting an application for 

certification, the applicable minimum 

biobased content for use of the label 

would be the minimum biobased 

content specified for that item in 7 CFR 

2902. As discussed in more detail 

below, once an item has been 

designated, its minimum biobased 

content, as specified in 7 CFR part 2902, 

becomes the applicable minimum 

biobased content for all products within 

that designated item, regardless of any 

previous minimum biobased content 

used to qualify a product for using the 

label. 

If a biobased product is marketed 

within more than one designated item, 

and uses the same packaging, its 

biobased content must meet or exceed 

the specified minimum biobased 

content for each of the designated items 

in order to use the label for each item. 

For example, Product A is currently 

marketed as a ‘‘glass cleaner’’ and a 

‘‘bath and tile cleaner’’ and uses the 

same packaging in both markets. USDA 

has designated both these categories of 

products as items under its BioPreferred 

procurement program. Product A has a 

biobased content of 60 percent. The 

minimum biobased content of 

designated item ‘‘glass cleaners’’ is 49 

percent and the minimum biobased 

content of designated item ‘‘bath and 

tile cleaners’’ is 74 percent. The 

manufacturer would not be eligible to 

apply for use of the label for Product A 

under either designated item. If the 

biobased content of Product A were 

instead 80 percent, the manufacturer 

would be eligible to use the label under 

both designated items. 

If, on the other hand, the 

manufacturer packaged the product in 

different packaging for marketing within 

the two designated items (e.g., a blue 

bottle for the glass cleaner and a green 

bottle for the bath and tile cleaner), the 

product marketed as a glass cleaner 

would be eligible to apply to use the 

label while the product marketed as 

bath and tile cleaner would not be 

eligible. 

2. Finished biobased products that are 

not within designated items. If a 

biobased product is not within a 

designated item at the time the 

application for certification is 

submitted, the applicable minimum 

biobased content for the product for 

using the label would be 51 percent, 


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unless USDA approves an alternative 

applicable minimum biobased content. 

The proposed rule would allow 

manufacturers, vendors, and trade 

associations (individually or 

collectively) who believe that the 51 

percent minimum biobased content is 

not appropriate for the biobased product 

to conduct an analysis, as discussed 

under ‘‘Alternative Minimum Biobased 

Content Analysis’’ later in this 

preamble, to support an alternative 

applicable minimum biobased content. 

If USDA approves the alternative 

applicable minimum biobased content, 

then that content becomes the 

applicable minimum biobased content 

for that product. 

USDA recognizes that there will be 

groups of biobased products that will be 

certified to use the label that will never 

be designated for preferred 

procurement, primarily because these 

products are produced by only one 

manufacturer and, thus, there is not 

sufficient market competition to justify 

preferred procurement or they are not 

used prevalently in the Federal 

marketplace. However, USDA expects 

that the majority of the biobased 

products certified to use the label will 

be within a group of products that 

USDA designates for preferred 

procurement. In those cases where 

USDA subsequently designates an item 

under which the certified biobased 

product falls for inclusion in the 

preferred procurement program, the 

applicable minimum biobased content 

for the product will then become the 

minimum biobased content established 

for the designated item under which the 

product falls. As of the effective date of 

the designation, only those products 

that meet the new minimum biobased 

content may continue to use the label. 

3. Products that are intermediate 

ingredients or feedstocks that are not 

within designated items. If a biobased 

product is an intermediate ingredient or 

feedstock and is not within a designated 

item at the time the application for 

certification is submitted, the applicable 

minimum biobased content for the 

product for using the label would be 51 

percent, unless USDA approves an 

alternative applicable minimum 

biobased content. As with the previous 

product category, the proposed rule 

would allow manufacturers, vendors, 

and trade associations (individually or 

collectively) who believe that the 51 

percent minimum biobased content is 

not appropriate to conduct an analysis, 

as discussed under ‘‘Alternative 

Minimum Biobased Content Analysis’’ 

later in this preamble, to support an 

alternative applicable minimum 

biobased content. If USDA approves the 

alternative applicable minimum 

biobased content, then that content 

becomes the applicable minimum 

biobased content for that product. 

Rationale for Criterion 2: USDA 

believes setting the applicable minimum 

biobased content of products within 

designated items at the minimum 

biobased content specified under the 

preferred procurement program is 

appropriate, as USDA has had an 

opportunity to perform an analysis on 

these products, including identifying 

similar biobased products and their 

manufacturers, and obtaining biobased 

contents for similar biobased products. 

USDA intends to proceed with the 

designation of numerous items for 

which it has, or is currently gathering, 

information. Once the designation 

process has been completed for those 

items that have been identified for 

designation, USDA intends to revisit, on 

a periodic basis, the minimum biobased 

content that was established for 

designated items at the time of their 

designation. As scientific advances and 

economic conditions warrant, USDA 

would expect that the applicable 

minimum biobased content for 

designated items will rise as 

competitors apply advances and 

increase the biobased content of 

designated products. Thus, it is USDA’s 

expectation that the applicable 

minimum biobased content of 

designated items will increase as 

advancements are made in biobased 

product technology. USDA also notes 

that proposed revisions to the 

applicable minimum biobased content 

for designated items will be announced 

in the Federal Register and the public 

will have an opportunity to provide 

comments on the proposal. 

For the second and third categories of 

products (finished biobased products 

and intermediate ingredients and 

feedstocks that are not within 

designated items) USDA considered 

several options for setting the minimum 

biobased content, including the use of 

the lowest minimum biobased content 

for any item designated to date. USDA 

decided, however, that in the absence of 

the level of detailed product 

information for setting a minimum 

biobased content based on productspecific data (as is used under the 

preferred procurement program), and in 

an effort to discourage minimal use of 

biobased feedstocks in what are 

otherwise not biobased products, it is 

reasonable to consider such finished 

products as ‘‘biobased’’ if they contain 

a significant amount of biobased 

materials; that is, at least 51 percent of 

the product is biobased. Thus, USDA is 

proposing that all finished products that 

are not within designated items and all 

intermediate ingredients and feedstocks 

that are not within designated items 

must contain at least 51 percent 

biobased content to be qualified for the 

label. 

USDA recognizes, however, that for 

some finished products (and 

intermediate ingredients) a 51 percent 

minimum biobased content may result 

in a product that is not viable. USDA 

also recognizes that the 51 percent 

minimum biobased content could 

discourage the development of new 

biobased products or the continued 

development of existing biobased 

products. With this in mind, USDA will 

continue to gather product-specific data 

under the preferred procurement 

program to determine applicable 

minimum biobased contents. 

Additionally, USDA believes that it is 

reasonable to provide a procedure to 

allow manufacturers, vendors, and trade 

associations to propose an alternative 

applicable minimum biobased content 

for such products. 

Alternative Minimum Biobased Content 

Analysis 

As noted above, manufacturers, 

vendors, and trade associations would 

be allowed to propose an alternative 

minimum biobased content for products 

not within a designated item if they 

believe that the proposed minimum 

biobased content is not appropriate for 

their product(s). For USDA to consider 

an alternative minimum biobased 

content for these types of products, 

manufacturers, vendors, and trade 

associations would be required to 

develop an analysis, in consultation 

with USDA, that demonstrates the need 

for an alternative applicable minimum 

biobased content. USDA believes that 

manufacturers, vendors, and trade 

associations should consult with the 

Department in developing the analysis 

to help ensure that an appropriate 

analysis is conducted. 

While the analysis of the data 

supporting a specific request for an 

alternative minimum biobased content 

will be performed on a case-by-case 

basis, USDA anticipates that the 

evaluation process will be standardized 

and will be similar to the process used 

to set minimum biobased contents 

under the preferred procurement 

program. Such a process would include 

identifying similar biobased products 

and their manufacturers and 

determining biobased contents for 

similar biobased products. USDA 

recognizes the difficulties involved in 

collecting biobased contents, due in 

large part to the unpredictability of 

manufacturer and vendor participation 


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2 ISO 9001 conformant means that the entity 

meets the requirements of ISO 9001, but is not 

required to be ISO 9001 certified. 

in providing products for testing. 

Similar to the process used in the 

preferred procurement program, the 

establishment of alternative minimum 

contents for the labeling program will 

require a measure of flexibility to 

address the variability in product type 

and level of industry development. In 

general, the number of samples that 

should be obtained for the biobased 

content analysis would depend on the 

number of manufacturers of a product 

and similar products available. USDA 

would expect applicants to coordinate 

with program officials to identify and 

agree upon a reasonable number of 

samples for the analysis. Emphasis 

would be focused on obtaining the 

maximum number of samples possible 

without restricting the analysis process. 

C. Initial Approval Process 

Application 

Manufacturers and vendors seeking 

use of the label on a qualified biobased 

product must submit to USDA a 

separate USDA-approved application for 

certification for each product for which 

the manufacturer or vendor wishes to 

receive USDA approval to use the label. 

Both the application and instructions 

for submittal of the application will be 

available on the USDA BioPreferred 

Web site. 

Each application must contain both 

contact and product information. 

Contact information would include the 

applicant’s name, mailing address, 

e-mail address, and telephone number, 

and the name, mailing address, 

telephone number, and e-mail address 

(if available) of the person who prepared 

the application. 

Product information would include 

the brand names or other product 

identifying information (such as model 

name or number, or UPC number) for 

the product, the biobased content of the 

product for which certification is 

sought, contact information on the 

third-party testing entity that tested the 

biobased content and documentation 

that the testing entity is ISO 9001 

conformant, the product category under 

which the product falls, and the 

intended uses of the product. If the 

product falls within a designated 

item(s), the applicant would also 

identify the name of the designated 

item(s). 

Lastly, the applicant would be 

required to sign a statement that 

certifies that the product identified in 

the application is a biobased product as 

defined in the labeling program and 

commits the applicant to provide to 

USDA, and to keep up-to-date, the 

product’s brand name(s), or other 

identifying information; contact 

information, including the name, 

mailing address, e-mail address, and 

telephone number of the applicant; the 

biobased content of the product; and a 

hot link directly to the applicant’s Web 

site (if available). USDA is also 

requiring that if manufacturers make 

claims on the product packaging about 

the environmental and human health 

effects, life-cycle costs, sustainability 

benefits, and performance of their 

products that documentation supporting 

such claims be maintained. 

Justification for Required Information 

USDA considers the information 

required for the initial approval process 

to be the minimum that will be needed 

by USDA to confirm that products meet 

the criteria for certification. The 

following paragraphs summarize the 

rationale for requiring the information 

specified. 

Contact Information. This information 

is necessary for communicating with the 

applicant concerning any issues with 

the application, whether the application 

is deficient, and whether the application 

has been approved. 

Brand Names. Because a 

manufacturer or vendor may market the 

same product under different brand 

names (or other product identifiers such 

as model names or numbers), the 

application requires that all brand 

names or other applicable product 

identifiers for that product be provided. 

This will prevent the necessity of 

multiple applications from the same 

manufacturer or vendor for the same 

product. 

Biobased Content Information. For 

products in the three categories 

discussed earlier, the biobased content 

of the product for which certification is 

sought would be determined by ISO 

9001 certified or conformant,2 thirdparty testing firms using ASTM Method 

D6866, ‘‘Standard Test Methods for 

Determining the Biobased Content of 

Natural Range Materials Using 

Radiocarbon and Isotope Ratio Mass 

Spectrometry Analysis.’’ 

In the case of a product that is 

marketed under different brand names, 

the proposed rule would allow the 

manufacturer or vendor to test the 

product once rather than requiring 

brand-name specific data, thereby 

minimizing unnecessary testing of the 

same product that is simply marketed 

under different brand names. 

The applicant is required to provide 

the product’s biobased content, as 

determined using ASTM Method D6866, 

and contact information on the entity 

that performed the testing. The 

applicant is also required to provide 

documentation that the third-party 

testing entity that determined the 

biobased content reported for the 

product is ISO 9001 conformant. This 

information is necessary to demonstrate 

that the product’s biobased content 

meets or exceeds the applicable 

minimum biobased content and that a 

qualified, independent, third-party 

testing entity conducted the testing. 

Product Category. The applicant is 

required to identify whether the product 

(1) falls within one or more designated 

items under the preferred procurement 

program (and if so, the applicant is 

required to identify the item(s)), (2) is a 

finished biobased product that is not 

within a designated item, or (3) is an 

intermediate ingredient or feedstock 

that is not within a designated item. 

This information is necessary to identify 

the applicable minimum biobased 

content and then to ensure that the 

biobased content of the product meets 

or exceeds the applicable minimum 

biobased content. 

Intended use(s). The applicant is 

required to provide a description of the 

intended uses of the product (e.g., as a 

glass cleaner or as a penetrating 

lubricant). USDA will use this 

description to confirm that the product 

is assigned to the appropriate 

designated item(s), if applicable. This 

will also allow USDA to determine if a 

product should have been assigned to a 

designated item, if the application 

incorrectly indicates that the product 

falls outside the designated item 

category. 

Certifications and statements. The 

applicant must certify that the product 

for which certification is sought is a 

biobased product, as defined by the 

labeling program. USDA is proposing 

that applicants certify to this criterion 

and keep appropriate records to 

demonstrate that the product complies 

with this certifying statement, which 

USDA can then review during an audit. 

This condition must be met in order to 

ensure compliance with statutory 

requirements under which the voluntary 

labeling program is being established. 

As noted earlier in this preamble, the 

applicant is also required to commit to 

providing to USDA information, and 

keeping it up-to-date, for posting by 

USDA on the BioPreferred Web site. 

This information includes the product’s 

brand name(s) or other product 

identifiers; contact information, 

including the name, mailing address, email address, and telephone number of 

the applicant; biobased content; and a 


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hot link directly to the applicant’s Web 

site (if available). 

While USDA is not requiring 

manufacturers to analyze the 

environmental and human health 

effects, life-cycle costs, sustainability 

benefits, and performance of their 

products, manufacturers making claims 

regarding these attributes of their 

products must maintain documentation 

to substantiate those claims pursuant to 

the Federal Trade Commission (FTC) 

Act. Section 5 of the FTC Act (15 U.S.C. 

45) makes unlawful deceptive acts and 

practices in or affecting commerce. The 

FTC ‘‘Guides for the Use of 

Environmental Marketing Claims’’ (16 

CFR part 260) state that ‘‘any party 

making an express or implied claim that 

presents an objective assertion about the 

environmental attribute of a product, 

package or service must, at the time the 

claim is made, possess and rely upon a 

reasonable basis substantiating the 

claim.’’ 

Evaluation 

USDA will evaluate each application 

to determine if it is a ‘‘complete’’ 

application (i.e., that it contains all of 

the required information). If USDA 

determines that the application is not 

complete, it will return the application 

to the applicant and provide an 

explanation of the deficiencies in the 

application. Once the deficiencies have 

been addressed, the applicant may 

resubmit the application for review by 

USDA. 

USDA will evaluate each complete 

application to determine if the product 

meets the criteria for certification 

discussed above (and specified in 

§ 2904.4). There will be no specified 

deadline for application submissions; 

applications will be worked on in a first 

come first serve basis. Based on this 

evaluation, USDA either will 

conditionally approve the application or 

will disapprove the application. USDA 

will provide to each applicant a written 

response within 60 days after the receipt 

of a complete application, informing the 

applicant whether or not its application 

has been conditionally approved or has 

been disapproved. An applicant who 

receives notice from USDA that its 

application has been conditionally 

approved may not begin using the label 

on its product until the applicant 

receives a notice of certification from 

USDA (see next paragraph). For those 

applications that are not approved, 

USDA will notify the applicant and 

identify each criterion not met. 

Applicants whose applications are not 

approved have the right to appeal under 

the proposed program first to USDA’s 

BioPreferred program office and then to 

USDA policy officials. 

Notice of Product Certification 

After an applicant receives notice 

from USDA that its application (for the 

product to bear the label) has been 

conditionally approved, the applicant 

must provide certain information, as 

discussed in Section E in this preamble, 

to USDA. Once USDA has confirmed 

that the information supplied by the 

applicant is complete, USDA will 

approve the product label application 

and will issue a notice of product 

certification to the applicant. USDA will 

include in the notice of certification 

information necessary for the applicant 

to access the applicable label artwork 

from the USDA BioPreferred Web site. 

Upon receipt of the notice of 

certification, the applicant may begin 

using the label on the certified biobased 

product. 

Term of Product Certification 

The effective (beginning) date of the 

product certification is the date that the 

applicant receives the notice of 

certification from USDA. The 

certification will remain valid for as 

long as the biobased product is 

manufactured in accordance with the 

information supplied in the approved 

application and presented on the USDA 

Web site, with one exception. As 

discussed earlier, it is USDA’s intent 

that the applicable minimum biobased 

content of designated items will 

increase over time as advancements are 

made in biobased product technology. If 

the applicable required minimum 

biobased content for a product to be 

eligible to display the label is revised by 

USDA, manufacturers and vendors may 

continue to label their previously 

certified product only if it meets the 

new minimum biobased content level. 

In those cases where the biobased 

content of a certified product fails to 

meet the new minimum biobased 

content level, USDA will notify the 

manufacturer or vendor that their 

certification is no longer valid. Such 

manufacturers and vendors must 

increase the biobased content of their 

product to a level at or above the new 

minimum biobased content level and 

must re-apply for certification within 60 

days of receiving USDA’s notice if they 

wish to continue to use the label. 

Manufacturers and vendors who have 

re-applied for certification may continue 

using the existing label until they 

receive notification from USDA on the 

results of their re-application for 

certification. 

USDA considered proposing a 

certification period of either three or 

five years, but decided that a fixed 

certification period was unnecessary 

and that the process of reapplying every 

three or five years would impose an 

undue burden on manufacturers who 

did not reformulate their products. In 

the case of items that become 

designated, it is likely that the required 

minimum biobased content for the item 

could be different from the 51 percent 

level used to qualify the item before it 

was designated. USDA believes that, in 

those cases, only those products that 

meet the new minimum biobased 

content should be eligible to display the 

label. Thus, USDA is proposing that if 

a certified product’s biobased content is 

below the newly established minimum 

biobased content, the manufacturer 

must discontinue applying the label as 

of the effective date of the item 

designation. The same would be true in 

any other case where USDA, through 

established notice and comment 

rulemaking procedures, revises the 

minimum biobased content applicable 

to a previously certified product. 

USDA points out that affixing the 

label to a certified biobased product 

does not imply that the useful life or the 

shelf life of the product has been 

affected in any way. Purchasers of 

labeled certified biobased products, 

therefore, should continue to look to 

information from the manufacturer or 

vendor to ascertain whether a product 

will perform as advertised at the time 

the purchase is made. 

D. Appeals 

Today’s proposed rule includes 

provisions for appeal by an applicant 

whose application for certification is 

denied by USDA. In addition, entities 

that have been cited for a violation or 

that have received a notice of 

suspension or a notice of revocation 

may also file an appeal. All appeals 

must be filed within 30 days of receipt 

of the applicable notice. Appeals must 

be made in writing to the Program 

Manager of the Voluntary Labeling 

Program for Biobased Products and 

must contain, in part, a statement, 

including appropriate substantiating 

documentation, of the appellant’s 

reasons for believing that USDA 

wrongfully denied the application or 

issued a notice of violation, suspension, 

or revocation. If the appellant is 

dissatisfied with the results of this 

appeal, he/she may raise the appeal to 

the Assistant Secretary for 

Administration by letter request. 

Appeals to the Assistant Secretary for 

Administration must be filed within 30 

days of receipt of the notice of decision 

from the appeal to the Program 

Manager. 


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The proposed rule also includes 

provisions for manufacturers or vendors 

of mature market products to appeal the 

exclusion of their products from the 

voluntary labeling program if they 

believe that conditions justify the use of 

the label on their products. 

E. Information Posted on Web Site 

Before USDA issues the notice of 

certification to a manufacturer or vendor 

to use the label on a biobased product, 

the manufacturer or vendor must submit 

contact and product information to 

USDA, which USDA will then post on 

the USDA BioPreferred Web site (which 

can be accessed at http:// 

www.biopreferred.gov). This 

information must be complete and must 

be provided to USDA before USDA will 

provide to the manufacturer or vendor, 

the notice of certification and the 

information for accessing the label 

artwork. The information that must be 

provided to USDA is: 

• Product brand name(s) or other 

identifying information; 

• Contact information for the 

applicant; 

• Biobased content level; and 

• A hot link directly to the 

applicant’s Web site (if available). 

In addition to the information listed 

above, USDA encourages manufacturers 

to provide other information related to 

product features and applicability for 

posting to the Web site. 

USDA believes that making the 

information identified above available 

on the USDA BioPreferred Web site will 

be an extremely valuable step in 

establishing a database of certified 

biobased products. Ideally, both Federal 

agencies and public consumers will be 

able to readily access information that 

will help them in their decision-making 

regarding the purchase of biobased 

products. USDA believes that making 

this information available not only to 

Federal agencies, but also to public 

consumers will result in increased 

consumer awareness of and use of 

biobased products. USDA is also 

proposing that manufacturers of 

certified biobased products must 

include the USDA Web site address on 

or in close proximity to the label. 

Manufacturers must provide to USDA 

updated information for posting by 

USDA to the USDA BioPreferred Web 

site whenever any of the information on 

the Web site becomes outdated or if 

additional relevant information becomes 

applicable. As discussed in Section I of 

this preamble, failure to provide USDA 

with updated information will be 

considered a violation of the 

requirements of the labeling program. 

F. Applications for Reformulated 

Products 

A manufacturer may decide to change 

the formulation of a certified biobased 

product for various reasons including 

performance issues, raw material 

availability, or changes in production 

processes. As discussed earlier, 

manufacturers may also be required to 

reformulate products that are within 

designated items in response to USDA 

re-evaluating and increasing the 

applicable minimum biobased content 

for products within the designated item. 

For such reformulated products to be 

eligible for USDA certification to use the 

label, USDA proposes that a new 

application be submitted to USDA, as 

discussed below. 

If a certified product’s biobased 

content is decreased by any amount, a 

new application would be required. In 

any case where the biobased content of 

a product is decreased from the original 

formulation, the biobased content of the 

reformulated product must still be at or 

above the applicable minimum biobased 

content for the product in order for the 

product to qualify for the label. 

In the case of a product whose 

biobased content is reduced, the 

manufacturer or vendor cannot affix the 

label to the reformulated product until 

they have submitted a new application, 

provided USDA with the required 

information on the reformulated 

product for posting to the USDA 

BioPreferred Web site, and received the 

notice of certification for the 

reformulated product from USDA. If the 

manufacturer or vendor also continues 

to sell the product in its original 

formulation, the manufacturer or vendor 

may continue to affix the label to the 

original product. 

If a certified product’s biobased 

content is increased, and the 

manufacturer wishes to change the label 

to report the higher value, a new 

application would be required. The 

manufacturer or vendor may continue to 

affix the label to the reformulated 

product. However, the manufacturer or 

vendor may not revise the biobased 

content displayed on the label until they 

have submitted a new application, 

provided USDA with the required 

information on the reformulated 

product for posting to the USDA 

BioPreferred Web site, and received the 

notice of certification for the 

reformulated product from USDA. 

G. Requirements Associated With the 

Label 

Today’s proposed rule establishes 

specific requirements for the use of the 

label. The requirements in today’s 

proposed rule specify who may use the 

label, correct and incorrect uses of the 

label, the physical appearance of the 

label, and restrictions on the use of the 

label. These requirements are 

summarized in the remainder of this 

section. 

USDA is also developing a Marketing 

Guide that will be made available to 

manufacturers and vendors of labeled 

products. The purpose of this Marketing 

Guide is to provide expanded 

discussions of, and guidance on 

resolving, implementation issues that 

may arise related to the use of the label. 

For example, USDA anticipates that 

there will be questions related to the 

best way to apply the label on very 

small products, such as those within the 

designated item ‘‘lip care products.’’ 

USDA believes that a Marketing Guide, 

that can be updated frequently, is the 

most efficient way to keep label users 

informed of guidance provided by 

USDA in response to implementation 

issues that arise. 

Who May Use the Label? 

Any manufacturer or vendor who has 

received notice of certification from 

USDA, and any designated 

representative of such manufacturers 

and vendors, may use the label on the 

product and its associated packaging 

and in the advertising of the certified 

biobased product. As proposed, only the 

manufacturer or vendor (and their 

designated representatives) of a certified 

biobased product would be granted the 

authority to affix the label to the 

product. The process of applying for 

and receiving certification requires 

specific knowledge of the product and 

its characteristics and formulation. 

Obtaining certification also imposes the 

requirement on the manufacturer and 

vendor to provide certain information to 

USDA, which USDA will then post on 

the USDA BioPreferred Web site. 

Other entities may use the label to 

advertise or promote certified biobased 

products (e.g., in catalogs or 

procurement databases), as long as the 

manufacturer or vendor of the product 

(or one of their designated 

representatives) has affixed the label to 

the product or its packaging. USDA 

believes that allowing other entities to 

use the label in informational, 

promotional, and educational materials 

for certified biobased products will 

promote the goal of encouraging the use 

of biobased products. 

Use of the Label 

The label may be affixed only to 

products (or associated packaging) for 

which a manufacturer or vendor has 

received a notice of certification under 


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this part. USDA’s intent is for the label 

to be used by manufacturers, vendors, 

and other entities to distinguish 

biobased products that meet or exceed 

the criteria established by USDA from 

those that do not meet the criteria. It is 

also important that the label be used in 

a consistent manner such that the label 

and its meaning will become 

recognizable in the marketplace. Use of 

the label on non-certified products or 

alterations in the appearance of the label 

may confuse consumers and diminish 

the value of not only the label, but also 

the entire biobased product program. 

Therefore, USDA has identified correct 

and incorrect uses of the label, which 

are discussed in the following 

paragraphs. 

Correct Uses. Proposed section 2904.7 

identifies correct usages of the label. 

These include, but are not limited to the 

following: 

• The label may be used in 

advertisements, catalogs, procurement 

databases, Web sites, and promotional 

and educational materials; 

• The label may appear next to a 

picture of the product(s) or text 

describing the product(s); and 

• The label may be used without 

reference to a specific certified biobased 

product only when informing the public 

about the purpose of the label. For 

example, the following or similar claim 

is acceptable: ‘‘Look for the ‘USDA 

Certified Biobased Product’ label. It 

means the product meets USDA 

standards for the amount of biobased 

content and the manufacturer or vendor 

has provided relevant information on 

the product for the USDA BioPreferred 

Web site.’’ This exception allows 

manufacturers, vendors, and other 

entities to use the label in documents 

such as corporate reports, but only in an 

informative manner, not as a statement 

of product certification. 

Incorrect Uses. Proposed § 2904.7 also 

identifies incorrect usages of the label. 

These include, but are not limited to the 

following: 

• The label may not be used on noncertified products or in advertisements 

or informational materials for noncertified products; 

• The label may not be used to imply 

endorsement by USDA or the 

BioPreferred Program of any particular 

product, service, or company; and 

• The label may not be used in any 

form that could be misleading to the 

consumer, or on business cards, 

company letterhead, or company 

stationery. 

Imported Products 

Because other countries may have 

different definitions of ‘‘biobased’’ 

and/or use other terms, it is necessary 

to address the use of the label on 

products for import. The ‘‘USDA 

Certified Biobased Product’’ label 

signifies that a product meets specific 

USDA criteria for biobased products. 

Therefore, in order for products 

imported for sale in the U.S. to carry the 

label, they must meet the same criteria 

as U.S.-sourced biobased products, and 

their manufacturers and vendors must 

apply for certification to use the label, 

even if the products are considered 

biobased products in the country in 

which they are manufactured. 

Contents of the Label 

The label must consist of the 

following: 

• The logo with the phrase ‘‘USDA 

Certified Biobased Product’’ and, where 

applicable, the letters ‘‘FP’’ to indicate 

that the product is within a Federally 

preferred designated item (this label 

content is collectively referred to as the 

‘‘label artwork’’); and 

• A statement that identifies the 

biobased content of the product, as 

reported in the approved application for 

the product at the time the label is 

affixed to the product or its packaging, 

and whether the label applies to the 

product or packaging. 

USDA is proposing that the statement 

that identifies the biobased content also 

indicate whether the label applies to the 

product or the packaging (e.g., Product: 

57% biobased; Packaging: 90% 

biobased). The USDA is proposing that 

this statement be included in the label 

in order to make it clear as to what the 

certified biobased product is. USDA 

believes that there will be instances 

where the placement of the label on a 

product or its packaging will not clearly 

identify the certified biobased product. 

For example, it is possible that a label 

placed on a container will refer to the 

container itself (in which case the 

statement ‘‘Packaging: XX% biobased’’ 

would be used) or to the contents within 

the container (Product: YY% biobased). 

It may also be possible that both the 

container and its contents are certified 

biobased products, in which case two 

statements would appear (Product: 

YY% biobased. Packaging: XX% 

biobased). Without tying the label to the 

product or the packaging, the consumer 

may be unable to determine which 

product is the certified biobased 

product. Therefore, USDA is proposing 

that the appropriate statement(s) be 

included in the label in order to identify 

clearly the product or products to which 

the label applies. 

Furthermore, the proposed rule 

requires that, at the time the label is 

affixed to the product or its packaging, 

the biobased content shown on the label 

is the same as the biobased content 

found in the approved application for 

the product. It is possible, however, that 

the biobased content of a certified 

product could be changed by the 

manufacturer. If a certified product’s 

biobased content is changed to a level 

below that shown on the label, the 

product is considered a reformulated 

product and a new application is 

required. If a certified product’s 

biobased content is increased and the 

manufacturer wishes to change the label 

to the higher value, a new application 

is also required. 

USDA also requires manufacturers 

and vendors to include the USDA 

BioPreferred Web site address on or in 

close proximity to the label. USDA is 

not proposing to require that the Web 

site address be on the label itself 

because the label on many products will 

not be large enough to accommodate 

this extra information. USDA believes 

that, where practicable, the presence of 

the USDA BioPreferred Web site address 

on the label will assist consumers in 

obtaining information about biobased 

products. 

Physical Aspects of the Label 

The rule addresses the physical 

aspects of the label artwork and the 

presentation of the biobased product 

statement. In addition to the 

requirements of the rule, USDA 

anticipates that guidance on specific 

issues related to the physical aspects of 

the label will be provided in the 

Marketing Guide. 

Label Artwork 

To maintain the distinctiveness of the 

label artwork (which consists of the 

logo, the phrase ‘‘USDA Certified 

Biobased Product’’ and, where 

applicable, the letters ‘‘FP’’) and to 

make sure that it is readily recognizable, 

USDA has established requirements 

related to the physical appearance of the 

label artwork. The applicable label 

artwork provided by the BioPreferred 

Program must be used. 

USDA is also proposing color 

requirements to ensure that the label 

artwork remains distinctive and 

recognizable. USDA is proposing to 

require that one of three label versions 

be used, depending on the need of the 

product. (1) A three-color version of the 

label artwork (white plus two shades of 

green); (2) a one-color version of the 

label artwork as long as the color used 

is one of the two greens specified in 

section 2904.7(f) of today’s proposed 

rule; and (3) a black and white version 

of the label artwork is also acceptable. 

The contrast between the light and dark 


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sections of the label artwork should be 

great enough to maintain the 

distinctiveness of the design. 

Finally, the label artwork may not be 

altered, cut, separated into components, 

or distorted in appearance or 

perspective. 

Biobased product statement. The 

applicable biobased product 

statement(s), which identifies the 

product(s) to which the label applies 

and the biobased content(s), would be 

placed below the label artwork. The 

biobased content must be expressed as 

‘‘XX%,’’ where XX% represents the 

actual biobased content of the product. 

The biobased content must be easily 

readable. Figure 1 illustrates the 

placement of the biobased product 

statement. 

Placement of the Label 

Whether the label is placed directly 

on a product, on associated packaging, 

in user manuals, or in other material, it 

should always be placed in a manner 

that ensures that the label (label artwork 

and biobased product statement(s)) can 

be readily associated with the 

applicable certified biobased product. 

The label should not be placed in a 

manner that is ambiguous about which 

product is a certified biobased product 

or that could indicate certification of a 

non-certified product. If all products on 

a printed page are certified biobased 

products, the label may be placed 

anywhere on the page. However, if a 

printed page contains a mix of certified 

biobased products and non-certified 

products, the label must be placed in 

close proximity to the certified biobased 

products. An individual label located 

near each certified biobased product 

may be necessary to avoid confusion. 

Minimum Size and Clear Space 

Recommendations for the Label 

USDA recognizes that a specific size 

requirement for the label would not be 

appropriate because of the variety of 

sizes and shapes of products that may 

be certified. Therefore, the label may be 

sized to be appropriate for the particular 

application as long as the correct 

proportions are maintained and the 

label remains legible. 

A border of clear space must surround 

the label and must be of sufficient width 

to offset it from surrounding images and 

text and to avoid confusion. If the 

label’s color is similar to the background 

color, an outlining color may be used to 

enhance contrast. 

Where To Obtain Copies of the Label 

Artwork 

The two versions of the label artwork 

(with and without the letters ‘‘FP’’, as 

applicable) will be available at the 

USDA BioPreferred Web site. Only 

manufacturers and vendors approved 

for use of the label for certified biobased 

products will be able to obtain the label 

from the Web site. USDA will provide 

the necessary access (through the notice 

of certification) once a manufacturer or 

vendor has provided USDA with the 

required information, which USDA will 

post to the USDA BioPreferred Web site, 

for a product whose application for 

certification has been approved by 

USDA. 

H. Violations 

Although the decision to participate 

in the certified biobased products 

labeling program is voluntary, 

compliance with the program 

requirements and specifications will be 

essential to the success of the program. 

Proposed section 2904.8 identifies 

examples of the types of actions that 

would be violations of the labeling 

program. 

To enforce the provisions of the 

voluntary labeling program, USDA will 

implement an audit program. This audit 

program will include, but not 

necessarily be limited to, conducting 

inspections of manufacturer and vendor 

facilities, visiting retail facilities, and 

testing the biobased content of certified 

biobased products. Visiting 

manufacturer and vendor facilities and 

inspecting their records, for example, 

will help USDA identify potential label 

and application violations. Testing 

certified biobased products for their 

biobased contents will help USDA 

determine any violations associated 

with biobased contents. Manufacturers, 

vendors, and their designated 

representatives are required to cooperate 

fully with all USDA audit efforts for the 

enforcement of the voluntary labeling 

program. USDA envisions selecting five 

to ten percent of labeled products at 

random for audit each year. 

Both the violations being proposed 

and any penalties associated with a 

violation would be applied on a per 

product basis. For example, a 

manufacturer has two certified biobased 

products, Product A and Product B. The 

manufacturer has been cited for a 

labeling violation for Product A and the 

certification for Product A has been 

revoked. As proposed, the manufacturer 

would be required to discontinue 

labeling Product A, and USDA would 

remove the information for Product A 

from the USDA BioPreferred Web site. 

If no actions were taken against the 

manufacturer with regard to Product B, 

the manufacturer’s certification for 

Product B would not be affected by the 

violation associated with Product A. 

Thus, the manufacturer would still be 

allowed to affix the label to Product B, 

and Product B’s information would 


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remain on the USDA BioPreferred Web 

site. 

Finally, the appeals process described 

previously is also applicable when a 

notice of violation, suspension, or 

revocation is issued. 

Biobased Content Violations. As 

noted earlier, as part of its audit 

program, USDA will conduct random 

tests of certified biobased products 

taken from market shelves to determine 

their biobased contents and compare the 

results to a product’s applicable 

minimum biobased content and the 

biobased content reported by the 

manufacturer or vendor in the approved 

application. USDA will conduct such 

testing using ASTM D6866, Standard 

Test Methods for Determining the 

Biobased Content of Natural Range 

Materials Using Radiocarbon and 

Isotope Ratio Mass Spectrometry 

Analysis. 

If the USDA testing shows that the 

biobased content of a certified biobased 

product is less than the applicable 

minimum biobased content identified in 

the approved application for the 

product, then a violation of the labeling 

regulations has occurred. 

If USDA testing shows that the 

biobased content of a certified biobased 

product is less than that reported in the 

approved application, but is still equal 

to or greater than the applicable 

minimum biobased content, USDA will 

notify the manufacturer or vendor of its 

results. USDA may forward the test 

results to the Federal Trade Commission 

for possible enforcement. The 

manufacturer or vendor would then 

have 30 days to submit a new 

application, showing a revised biobased 

content for the product. The revised 

biobased content could be either the 

biobased content from the USDA test or 

a biobased content reported by the 

manufacturer or vendor based on a new 

test conducted by the manufacturer or 

vendor. If the manufacturer or vendor 

elects to conduct a new biobased 

content test, the manufacturer or vendor 

must test a current sample of the 

product. Failure to provide a new 

application (including new test results) 

with a revised biobased content within 

30 days of receipt of USDA’s written 

notification would be considered a 

violation. 

USDA notes that if its testing shows 

that the biobased content of a certified 

biobased product is greater than the 

biobased content reported in the 

approved application, no violation 

would have occurred. USDA will, 

however, notify the manufacturer or 

vendor of the results of the testing, ask 

if they would like to submit a second 

product test, and potentially be allowed 

to increase the biobased content shown 

on their label. 

Label Violations. Any usage or 

display of the label that does not 

conform to the requirements proposed 

in section 2904.7 would be considered 

a violation of the proposed labeling 

regulations. For example, applying a 

label to a product that does not have a 

valid certification would be a label 

violation. 

Application Violations. Knowingly 

providing false or misleading 

information in any application for 

certification of a biobased product 

would be a violation of the proposed 

labeling regulations. For example, 

certifying in the application that the 

product meets the definition of a 

biobased product when it does not 

would be an application violation. 

USDA BioPreferred Web site 

Violations. As proposed, failure to 

provide to USDA updated information 

on a certified biobased product when 

the information for the certified 

biobased product becomes outdated 

(e.g., a change in a product’s biobased 

content), would be a violation. 

Notice of Violations and Associated 

Actions. When a violation has been 

identified, USDA will provide written 

notification of the violation to the 

applicable entity, which may be the 

manufacturer, vendor, or its designated 

representative or other entity. In all 

instances, the manufacturer of the 

product for which USDA has identified 

the violation will also be notified. The 

notice of violation will identify the 

violation. In the case of biobased 

content violations, the offending party 

will then have 30 days from the date the 

notice of violation is received to correct 

the violation. For other types of 

violations, the offending party will have 

60 days from the date the notice of 

violation is received to correct the 

violation. The 30-day period for 

resolving violations of biobased content 

violations is more stringent than the 60- 

day period allowed for resolving other 

types of violations because biobased 

content violations, whether intentional 

or not, are viewed as misleading 

consumers and could result in 

inappropriately influencing their 

purchasing decisions. 

If the party receiving the notice of 

violation is an ‘‘other entity,’’ USDA 

will pursue remedies as provided for 

under proposed section 2904.8(c). If the 

party is a manufacturer, vendor, or one 

of its designated representatives, USDA 

will first pursue notices of suspension 

and revocation, as discussed below. 

USDA also reserves the right to pursue 

other remedies as provided in 

§ 2904.8(c). 

Suspension of Certification. After 

receiving a notice of violation, if the 

manufacturer, vendor, or designated 

representative, as applicable, fails to 

make the required corrections within 60 

days (or 30 days, in the case of biobased 

content violations), USDA will notify 

the manufacturer or vendor of the 

continuing violation and will suspend 

USDA certification for that product. As 

of the date the manufacturer or vendor 

receives a notice suspending product 

certification, the manufacturer or 

vendor and any designated 

representatives must not affix the label 

to any of that product, or associated 

packaging, not already labeled. Also, the 

manufacturer or vendor must not 

distribute any additional products 

bearing the label after receiving a notice 

of suspension of product certification. 

When USDA suspends a product’s 

certification, USDA will issue a press 

release informing the public of the 

suspension and will also remove the 

information on that product from the 

USDA BioPreferred Web site. If USDA 

learns that entities whose certification 

has been suspended continue to use the 

label, USDA will refer that information 

to the Federal Trade Commission for 

enforcement. 

In order to resume use of the label for 

a product whose certification has been 

suspended, the manufacturer, vendor, or 

designated representative must correct 

the violation and notify USDA that the 

violation has been corrected within 30 

days from receipt of the notice of 

suspension and must receive approval 

from USDA before use of the label can 

be resumed. Once USDA has approved 

the corrections to the violation, USDA 

will restore the product information to 

the USDA BioPreferred Web site. 

Revocation of Certification. If a 

manufacturer or vendor whose USDA 

product certification has been 

suspended fails to make the required 

corrections within 30 days of the date of 

the suspension, USDA will notify the 

manufacturer or vendor that the 

certification for that product is revoked. 

As of the date that the manufacturer or 

vendor receives the notice revoking 

USDA certification, the manufacturer or 

vendor and any designated 

representatives must not affix the label 

to any of that product, or associated 

packaging, not already labeled. In 

addition, the manufacturer or vendor 

and its designated representatives are 

prohibited from further sales of the 

product to which the label has already 

been affixed to any entity. However, if, 

prior to receipt of a notification of 

revocation, a manufacturer or vendor 

has stored a supply of product with the 

label that has already been sold to 


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another entity, the manufacturer or 

vendor must notify the entity of the 

label revocation and allow the entity to 

cancel the transaction. If a manufacturer 

or vendor whose product certification 

has been revoked wishes to use the 

label, the manufacturer or vendor must 

follow the procedures required for 

original certification. 

Other Remedies. In addition to the 

suspension or revocation of the 

certification to use the label, depending 

on the nature of the violation, USDA 

may pursue suspension or debarment of 

the entities involved in accordance with 

part 3017 of this title. USDA further 

reserves the right to pursue any other 

remedies available by law, including 

any civil or criminal remedies, against 

any entity that violates the provisions of 

this part. 

I. Recordkeeping Requirements 

Manufacturers and vendors who 

choose to participate in the voluntary 

labeling program will be required to 

keep certain records related to their 

labeled biobased products. USDA 

believes these records are necessary to 

ensure compliance with the labeling 

regulations. Manufacturers and vendors 

may keep these records in either 

electronic or hard copy format. The 

records that must be kept include: 

• The results of all tests, and any 

associated calculations, performed to 

determine the biobased content of the 

product; 

• The results, and the supporting 

documentation, of industry standard 

functional performance tests to support 

product performance claims made by 

the manufacturer or vendor; 

• The results, and the supporting 

documentation, of analyses the 

manufacturer or vendor has performed 

to support claims of environmental or 

human health effects, life cycle costs, 

and sustainability benefits of the 

product; 

• Documentation that the product for 

which certification is sought meets the 

definition of biobased product, as 

defined in § 2904.2 of this part; and 

• The date of the certification by 

USDA and the dates when the biobased 

content of certified biobased products 

was tested. 

Records created under the 

requirements of today’s proposed rule 

must be maintained for at least three 

years beyond the end of the label 

certification period (i.e., three years 

beyond the period of time when 

manufacturers and vendors cease using 

the label). If electronic records are 

maintained, they must be readily 

accessible during an audit by USDA. 

USDA believes that a three-year record 

retention period is the minimum 

necessary to allow verification of the 

information supporting active 

certifications. Manufacturers, vendors, 

and their designated representatives 

must allow Federal representatives 

access to these records for inspection 

and copying during normal Federal 

business hours to determine compliance 

with the applicable regulations. 

J. Reporting 

USDA encourages manufacturers 

certified to use the label to provide data 

in order to enable USDA to estimate and 

publicly report the benefits and general 

effectiveness of the Voluntary Labeling 

Program. The quantity, frequency, and 

format of the data will be as the parties 

mutually agree. Such data may include, 

if and as available: (1) The total number 

of units of each product shipped by 

manufacturer for sale in the U.S., and 

(2) the type of customer (e.g., 

government, other public institution, 

private/corporate institution, private 

individual) to whom such products 

were sold. 

USDA recognizes that manufacturers 

and vendors may consider some of the 

requested information to be 

confidential. USDA stresses that 

information claimed as confidential by 

the manufacturer or vendor will not be 

released and that individual 

manufacturer or vendor data will not be 

reported. Only summary information 

regarding the benefits and impacts of 

the entire program will be released. 

IV. Suggested Comment Topics 

USDA invites comment on any aspect 

of today’s proposed requirements for the 

voluntary labeling program for biobased 

products. USDA invites specific 

comments in the areas identified below. 

1. Who can apply for the label? Under 

the proposed rule, both manufacturers 

and vendors of biobased products can 

apply for use of the label for their 

products. USDA is interested in 

comments on whether it is appropriate 

to include vendors as an entity eligible 

to apply for use of the label. Some of the 

requirements associated with approval 

for use of the label will require 

information generally only available to 

the manufacturer. In addition, it is the 

manufacturer, not the vendor, who 

determines a product’s formulation and 

production process. What issues would 

a vendor face in complying with the 

proposed rule in light of this? 

2. Applicable minimum biobased 

contents. For products (including 

intermediate ingredients and feedstocks) 

not within a designated item, USDA is 

interested in comments associated with; 

(a) the 51 percent applicable minimum 

biobased contents that products within 

this category must meet in order to be 

eligible for use of the label, and (b) the 

procedure under which an applicant 

can request an alternative applicable 

minimum biobased content (i.e., an 

applicable minimum biobased content 

other than 51 percent). 

3. The labeling of ‘‘complex 

products.’’ In addition to the three 

categories of products (products within 

designated items, those that are not 

within designated items, and those that 

are intermediate ingredients and 

feedstocks that are not within 

designated items) that would be eligible 

to use the label under today’s proposed 

rule, USDA also intends to develop 

provisions for the labeling of ‘‘complex 

products’’ once several implementation 

issues have been resolved. A complex 

product is considered to be a finished, 

consumer product that is composed of 

many different types of components. 

Examples of complex products would 

be products such as computers, vacuum 

cleaners, lawn mowers, and 

automobiles. Each of these products 

contains many component parts made of 

different materials. For products such as 

these, it may be feasible to produce one 

or more of the component parts with 

biobased materials. 

Today’s proposed rule does not 

contain provisions to allow for the 

labeling of complex products because 

there is currently no approved method 

to determine the biobased content of a 

complex product. USDA has consulted 

with ASTM representatives regarding 

the lack of an approved test method. 

ASTM is gathering information on 

complex products and they intend to 

proceed with the development of a 

method that can be used to determine 

the biobased content of complex 

products. USDA will continue to work 

closely with ASTM and the 

manufacturers of complex products and, 

once an acceptable test method is 

available, expects to amend the 

voluntary labeling rule to allow for the 

labeling of complex products. 

USDA requests that commenters 

provide information on the types of 

complex products containing biobased 

components that are in the marketplace 

today, as well as those which may be in 

the developmental stage. Information on 

the types of components that contain 

biobased materials, the typical biobased 

content of these components, and the 

market share of the biobased 

components is requested by USDA. 

Information on current research efforts 

to develop new biobased components 

for complex products is also requested. 

USDA is also interested in commenters’ 

opinions regarding how complex 


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products and their biobased 

components should be addressed in the 

designation process as well as the 

voluntary labeling program. 

4. The labeling of ‘‘mature market 

products.’’ The proposed rule does not 

allow the label to be applied to products 

that are considered to be ‘‘mature 

market products’’ (i.e., products that 

had significant market penetration in 

1972), except on a case-by-case basis. 

Section 2902.5(c)(2) of the final 

Guidelines also excludes mature market 

products from the designation process. 

However, USDA is proposing to allow 

manufacturers of mature market 

products to appeal (on a case-by-case 

basis) the exclusion of their products 

from the voluntary labeling program if 

they believe that conditions justify 

special consideration for their products. 

A possible example would be the 

manufacturer of a traditional biobased 

product that had a significant market 

share in 1972, lost that market share to 

petroleum-based alternative products 

during the years between 1980 and 

2000, is now attempting to re-enter the 

market, and believes the label will be 

helpful in this attempt. Other instances 

where USDA might consider granting 

appeals of the exclusion of mature 

market products include those where 

labeling a product could be shown to: 

reduce dependence on foreign 

petroleum sources; create new ‘‘green’’ 

jobs; or reduce greenhouse gas 

emissions. 

USDA welcomes comment on 

whether mature market products should 

be eligible for labeling and whether the 

labeling of mature market products 

could negatively affect the entry of new 

(i.e., post-1972) biobased products into 

market segments in which mature 

products already have significant 

market shares. USDA also requests 

comments regarding what criteria 

should be used to evaluate appeals to 

include mature market products in the 

labeling program and what types of 

information manufacturers and vendors 

should be required to submit as 

justification for their appeal. 

Commenters should provide specific 

reasons why the use of the label on 

mature market products should be 

considered, including information on 

the expected benefits of the label. USDA 

is also seeking comments on why this 

label might be preferred over, or how it 

could be used in conjunction with, 

other available labels such as the 

‘‘cotton,’’ ‘‘renewable,’’ or ‘‘organic’’ 

labels that can be used on many mature 

market products. 

5. The appropriate lengths for the 

certification periods. USDA is proposing 

that certifications remain valid for as 

long as the certified product is 

manufactured in accordance with the 

approved application. USDA considered 

a certification of either three or five 

years, but chose not to propose a 

specified time period, primarily to 

reduce the burden that would be 

associated with reapplying for 

certification. USDA welcomes 

comments on the appropriate length of 

time that a certification should be valid. 

Be sure to include rationale for any 

recommendations of alternative 

certification periods. 

6. Preliminary notice of violations. 

USDA welcomes comments on whether 

a preliminary notice of violation for any 

of the proposed violations should be 

issued before action is taken by USDA 

against the violators and, if so, how long 

a violator should be given to correct the 

violation before action is taken. 

7. Biobased content testing facilities. 

USDA solicits comments on the 

appropriateness of requiring that labs be 

ISO 9001 conformant. Specifically, are 

there benefits in such a requirement in 

terms of the quality of the resulting data 

and, if so, is ISO 9001 the appropriate 

standard? Commenters are encouraged 

to provide their opinions on whether 

there are other standards (such as ISO 

17025) that would be more appropriate. 

8. Clarification of biobased content of 

product vs. packaging on label. As 

discussed earlier in this preamble, 

USDA believes that it is important to 

identify for the consumer the item to 

which the label applies. Therefore, 

USDA is proposing that the label 

include the appropriate biobased 

product statement(s) to make this clear. 

USDA seeks comments to determine if 

the use of the word ‘‘product’’ in the 

statement ‘‘Product: YY% biobased’’ is 

clear enough. For example, if the label 

applies to a biobased hydraulic fluid, 

but not to its container, does the 

statement ‘‘Product: YY% biobased’’ 

found on the container clearly convey 

that the label applies to the hydraulic 

fluid and not the container? If this 

statement does not clearly convey this, 

please suggest alternatives that would 

more clearly accomplish this. 

When the label applies to both the 

product and its packaging, is it 

necessary to provide the biobased 

content of both the product and its 

packaging? As proposed, two statements 

would be included on the label 

(Product: YY% biobased. Packaging: 

XX% biobased). USDA welcomes 

suggestions on how to address 

providing biobased content information 

when the label applies to both the 

product and its packaging. 

9. Identifying products that are also 

eligible for a Federal procurement 

preference under the preferred 

procurement program. As proposed, 

biobased products that fall within 

designated items and are, therefore, 

eligible for Federal preferred 

procurement, would use a label with the 

letters ‘‘FP’’ included in the label 

artwork. USDA considered simply 

allowing manufacturers to indicate in 

the product’s literature that the product 

is eligible for preferred procurement 

rather than requiring such information 

on the label itself. USDA decided that 

there may be a benefit to either Federal 

agencies or to the public consumers to 

have this information on the label. 

USDA is seeking comments on whether 

the ‘‘FP’’ lettering on the label will be 

sufficient to distinguish products that 

are eligible for Federal preferred 

procurement. USDA is also requesting 

comments on whether consumers will 

recognize that the lettering on products 

means that these products, or similar 

products, have undergone life cycle 

costs and environmental performance 

analyses. USDA also welcomes 

comments on how the labeling program 

and the preferred Federal procurement 

program should work together. 

10. Other possible label content. As 

discussed above, USDA is proposing 

that the label include the biobased 

content (expressed as a percentage), a 

statement indicating whether the 

biobased content refers to the product or 

the packaging or both, and the 

BioPreferred Web site address (either on 

or in close proximity to the label). 

USDA also considered the possible 

advantages and disadvantages of 

requiring additional information on the 

label. For example, USDA is proposing 

that information on product 

performance and on the life-cycle costs 

and environmental and human health 

effects of the labeled products be 

maintained if manufactures make claims 

regarding these attributes for their 

products. USDA considered whether 

providing this type of additional 

information on the label would be 

beneficial to purchasers. 

The primary advantage of providing 

additional information on the label is to 

further educate purchasers about the 

attributes of the biobased products they 

choose to purchase. However, because 

the results of these analyses would 

typically be available only for labeled 

biobased products, a comparison to nonlabeled biobased, or non-biobased, 

competing products may often be 

impossible. Also, the amount of space 

that would be needed for a legible 

presentation of this information could 

be a serious drawback for many small 

products (e.g., household cleaners, hair 

care products, lip care products). 


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USDA is proposing to require 

manufacturers to include the 

BioPreferred Web site address either on 

or in close proximity to the label. USDA 

is requesting comments on the possible 

benefits of this proposed requirement 

and also on any expected drawbacks or 

negative impacts. 

USDA requests comments and 

recommendations regarding the value of 

providing the types of additional 

information discussed above on the 

label and specifically requests input on 

what types of information should be 

included and how it should be 

presented. 

11. Legibility of the label. As 

proposed, the label would consist of two 

items, the label artwork and the 

biobased product statement(s) with the 

accompanying biobased content(s). This 

is a significant amount of information 

and, for some small products, could 

result in a label that is difficult to read. 

Therefore, USDA is seeking comment on 

ways to help ensure that the information 

proposed to be included will be legible. 

Depending on the comments it receives 

and the rationale behind those 

comments, USDA may require a 

different presentation of this 

information. 

12. Timeframe for correcting 

violations. Under the proposed rule, 

USDA would allow up to 60 days for 

entities to correct violations (30 days for 

biobased content violations) before a 

notice of suspension or other remedy is 

sought. USDA is seeking comment on 

whether it is preferable for the 

timeframe to correct a violation to be 

fixed, including the appropriate length 

to allow (e.g., are the 30- and 60-day 

periods in the proposed rule 

reasonable?) or to be determined on a 

case-by-case basis to be specified in the 

notice of violation. 

13. Recordkeeping. The proposed rule 

requires certain records be kept in order 

to allow USDA to verify information 

associated with the labeling program 

and that these records be kept for at 

least three years beyond the end of the 

label certification period (i.e., three 

years beyond the period of time when 

manufacturers and vendors cease using 

the label). USDA welcomes comments 

on the specific records to be kept and 

the length of time they must be kept, 

including comments related to 

recordkeeping costs. 

14. Benefits and Costs. USDA requests 

comments on the potential benefits 

(social and private) and costs (e.g., 

testing, submitting applications and 

associated information, and 

recordkeeping) of the proposed rule. 

15. Application Fee. USDA is 

considering the option of charging an 

application fee for each application to 

use the label. While Departmental 

Administration does not currently have 

the statutory authority to collect such a 

fee, available options are being 

explored. As discussed elsewhere in 

this preamble, USDA plans to 

implement an audit program to ensure 

compliance with the requirements for 

the use of the label. Based on experience 

with other programs, USDA believes it 

may be necessary to assess user fees in 

order to maintain a viable audit 

program. The proceeds from the 

application fee would, therefore, be 

used to help offset the cost of the audit 

program. USDA believes that it is in the 

best interest of not only USDA but also 

the manufacturers of labeled products 

that an audit program be implemented 

so that the integrity of the label can be 

assured. Were authority provided to do 

so, USDA would consider charging a fee 

of $500 for each submitted application 

and requests comments on the 

appropriateness of that amount as well 

as on the charging of a fee at all. 

Please be sure to include your 

rationale for all suggested changes to the 

proposed rule. Comments must be 

submitted as directed in the ADDRESSES

section of this notice. 

V. Regulatory Information 

A. Executive Order 12866: Regulatory 

Planning and Review 

Executive Order 12866 requires 

agencies to determine whether a 

regulatory action is ‘‘significant.’’ This 

proposed rule has been reviewed under 

Executive Order (EO) 12866 and has 

been determined to be significant. 

Today’s proposed rule establishes a 

voluntary labeling program that allows 

manufacturers and vendors of certified 

biobased products to use the ‘‘USDA 

Certified Biobased Product’’ label. 

Although the labeling program is 

voluntary, there will be costs associated 

with meeting the criteria for, and 

applying for, certification to use the 

label. 

1. Costs of the Proposed Rule 

The primary costs associated with 

participating in this program are those 

for developing applications, testing to 

document the biobased content of 

products, providing information to 

USDA for posting by USDA on the 

USDA BioPreferred Web site, 

maintaining applicable records, and 

redesigning the product packaging to 

incorporate the label. USDA estimates 

that the combined annualized cost of 

the voluntary program, as proposed, to 

manufacturers and vendors would 

average approximately $2,813,811 per 

year for the first three years of the 

program. USDA estimates an average of 

352 manufacturers and vendors per year 

will submit applications to participate 

in the labeling program for the first 

three years of the program. This yields 

an average annualized cost per 

manufacturer/vendor of approximately 

$7,994. 

The level of presumed impact is not 

expected to exceed $100 million 

because of the offsetting nature of the 

labeling program (i.e., an increase in 

demand for biobased products is likely 

to be offset by a decrease in demand for 

non-biobased products). While the 

program is anticipated to have a 

widespread effect on the marketplace 

(including shifting purchases away from 

non-biobased products toward the 

purchase of biobased products), it is not 

expected to have a widespread adverse 

effect on the economy. 

2. Benefits of the Proposed Rule 

As an integral part of USDA’s 

BioPreferredSM Program, the voluntary 

labeling program is expected to raise 

public awareness of, and increase the 

demand for, biobased products. While 

the benefits of the labeling program are 

not quantifiable at this time, an 

increased demand for biobased products 

will, in turn, achieve the benefits as 

outlined in the objectives of section 

9002: To increase domestic demand for 

many agricultural commodities that can 

serve as feedstocks for production of 

biobased products; to spur development 

of the industrial base through valueadded agricultural processing and 

manufacturing in rural communities; to 

enhance the Nation’s energy security by 

substituting biobased products for 

products derived from imported oil and 

natural gas; and to substitute products 

with a possibly more benign or 

beneficial environmental impact, as 

compared to the use of fossil energybased products. On a national and 

regional level, today’s proposed rule can 

result in expanding and strengthening 

markets for biobased materials used in 

these items. The program is also 

expected to promote economic 

development for biobased product 

manufacturers and vendors by creating 

new jobs and providing new markets for 

farm commodities. 

B. Regulatory Flexibility Act (RFA) 

Under the RFA, an agency is not 

required to prepare a regulatory 

flexibility analysis of any rule subject to 

notice and comment rulemaking 

requirements under the Administrative 

Procedure Act or any other statute if the 

agency can certify that the rule will not 

have a significant economic impact on 


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a substantial number of small entities. 

Small entities include small businesses, 

small organizations, and small 

governmental jurisdictions. 

Of these three types of entities, the 

labeling requirements in today’s 

rulemaking would be applicable to 

small businesses only. For purposes of 

assessing the impacts on small entities, 

a small business is defined by the RFA 

using the definitions for small business 

based on Small Business Administration 

size standards, which vary depending 

on the type of business (e.g., less than 

500 employees, less than 1,000 

employees). Most of the manufacturing 

companies and vendors associated with 

products within items that USDA has 

designated or proposed for designation 

would qualify as small businesses under 

SBA guidelines. 

While we do not have enough 

information to evaluate fully the 

potential effect of this proposed rule on 

small entities, we have some 

information to make some initial 

conclusions. We identified six North 

American Industrial Classification 

System (NAICS) categories under which 

many biobased products are 

manufactured: Petroleum lubricating oil 

and grease manufacturing, plastics 

material and resin manufacturing, soap 

and other detergent manufacturing, 

urethane and other foam product 

(except polystyrene) manufacturing, 

carpet and rug mills manufacturing, and 

fertilizer manufacturing. We then used 

economic census data to determine the 

average value of shipments, a reasonable 

surrogate for annual sales, for 

companies in these categories. The 

analysis indicates that the average value 

of shipments in 2002, the most recent 

year for which there are complete 

census data, for the six NAICS 

categories examined is over $10 million 

per year per establishment. USDA 

requests comments on the quality of this 

analysis and ways to improve it. 

More recent manufacturing census 

data on firm size, from 2006, indicates 

that, collectively, over 94 percent of the 

firms in the six categories meet the 

Small Business Administration 

definition of small business for the six 

categories. 

The benefit-cost analysis USDA 

conducted for the proposed rule, 

discussed in Section I. below, indicates 

that the annualized cost associated with 

participating in the voluntary labeling 

program is about $7,994 on average and, 

relative to total sales by small 

businesses in the NAICS categories 

where many biobased products are 

manufactured, appears not to represent 

an undue burden in most cases. 

Moreover, participation in the 

voluntary labeling program would 

provide manufacturers and vendors a 

marketing advantage over those who 

choose not to participate. This 

marketing advantage could lead to 

greater sales, thus offsetting some of the 

costs associated with participating in 

the labeling program. 

Finally, the program requirements for 

the voluntary labeling program are 

applicable to all manufacturers and 

vendors of biobased products seeking to 

use the label under this program, 

regardless of the size of their business. 

For instance, all manufacturers and 

vendors are required to submit an 

application, conduct certain testing, and 

provide to USDA certain information 

that USDA will post to the BioPreferred 

Web site. These requirements are 

necessary to certify biobased products 

and are independent of the size of the 

manufacturer or vendor. The integrity of 

the labeling program would be 

compromised if biobased products 

manufactured by small businesses were 

allowed to be subject to different criteria 

in order to reduce costs to small 

businesses. 

Based on this initial analysis, USDA 

has not prepared a Regulatory 

Flexibility Analysis because USDA has 

determined that this rule does not have 

a significant impact on a substantial 

number of small entities. 

C. Executive Order 12630: 

Governmental Actions and Interference 

With Constitutionally Protected Property 

Rights 

This proposed rule has been reviewed 

in accordance with Executive Order 

12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights, and does not 

contain policies that would have 

implications for these rights. 

D. Executive Order 13132: Federalism 

This proposed rule does not have 

sufficient Federalism implications to 

warrant the preparation of a Federalism 

Assessment. Provisions of this proposed 

rule will not have a substantial direct 

effect on States or their political 

subdivisions or on the distribution of 

power and responsibilities among the 

various government levels. 

E. Unfunded Mandates Reform Act of 

1995 

This proposed rule contains no 

Federal mandates as defined under the 

regulatory provisions of Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA), 2 U.S.C. 1531–1538, for State, 

local, and tribal governments, or the 

private sector. Therefore, a statement 

under section 202 of UMRA is not 

required. 

F. Executive Order 12372: 

Intergovernmental Review of Federal 

Programs 

For the reasons set forth in the Final 

Rule Related Notice for 7 CFR part 3015, 

subpart V (48 FR 29115, June 24, 1983), 

this program is excluded from the scope 

of Executive Order 12372, which 

requires intergovernmental consultation 

with State and local officials. This 

program does not directly affect State 

and local governments. 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Today’s proposed rule does not 

significantly or uniquely affect the 

communities of Indian tribal 

governments. The proposed rule does 

not impose any mandate on tribal 

governments or impose any duties on 

these entities. Thus, no further action is 

required under Executive Order 13175. 

H. Paperwork Reduction Act 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.), USDA is seeking OMB approval 

of the reporting and recordkeeping 

requirements contained in this proposed 

rule. USDA conducted a burden 

analysis of the costs associated with this 

proposed rule, as well as a benefit-cost 

analysis. The primary costs of 

participating in the voluntary labeling 

program are the costs of testing the 

biobased content of products and the 

costs of labor associated with reading 

the rule, applying for certification, 

gathering and submitting the 

information for posting to the 

BioPreferred Web site, and keeping 

applicable records for the products for 

which certification is sought. See the 

contact information at the end of this 

section for details on how to request a 

copy of materials related to the 

Information Collection Request. 

Methodology 

To estimate the average annual 

burden over the first three years of the 

rule, USDA estimated the number of 

hours that each activity (e.g., read the 

rule, complete the application, submit 

information to USDA, appeal denied 

applications, keep records) would take, 

summed the estimates for each activity 

to get an average total number of hours 

per manufacturer/vendor, and 

multiplied that total by the estimated 

number of manufacturers/vendors. The 

total cost of biobased content testing 

was then projected by multiplying the 

estimated total number of biobased 


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products for which certification is 

expected to be sought by the cost of the 

test. The labor component of the cost 

and the testing component were then 

summed to give a total estimated 

burden. 

Assumptions 

In estimating the costs for the burden 

analysis, USDA made the following 

assumptions. 

1. In the first year of the voluntary 

labeling program, USDA estimates that 

100 items will have been designated as 

eligible to receive the procurement 

preference, another 36 items will have 

been designated in the second year of 

the labeling program, and another 30 

items will have been designated in the 

third year of the labeling program. 

2. Based on information gathered 

during the item designation 

rulemakings, USDA estimates that 

approximately 830 manufacturers of 

products within these 166 designated 

items and an additional 830 

manufacturers of biobased products 

(including intermediate ingredients or 

feedstocks) within items that are not 

designated for preferred procurement 

are expected to have an interest in using 

the label, yielding 1,660 manufacturers 

with eligible biobased products over the 

first three years. USDA estimates that an 

additional 200 vendors over the first 

three years would be interested in the 

voluntary labeling program. This yields 

a total of 1,860 manufacturers and 

vendors. Finally, USDA estimates that 

166 other entities over the first three 

years would be interested in the 

voluntary labeling program. 

3. Because the voluntary labeling 

program is new and the benefits to 

manufacturers of labeling their biobased 

products are not yet demonstrated, 

USDA anticipates that many 

manufacturers may be reluctant to 

participate during the first few years of 

the program. USDA expects that during 

the first three years of the program, 

participation by one half to two thirds 

of eligible manufacturers/vendors 

would be a reasonable estimate. 

Therefore, USDA assumed that sixty 

percent of the manufacturers of 

products within designated items, sixty 

percent of the manufacturers of 

products that are not within designated 

items, and thirty percent of the vendors 

with eligible biobased products would 

apply for certification to use the label. 

Thus, 1,056 manufacturers and vendors 

((830 × 0.6) + (830 × 0.6) + (200 × 0.3) 

= 1,056) would apply to use the label 

over the first three years (an average of 

352 per year). 

4. Based on information gathered to 

support the designation of items for 

preferred procurement, the average 

number of biobased products per 

manufacturer is between six and seven. 

For this analysis, USDA estimates that 

each applicant would submit 

applications for six products. This 

results in the submittal of 2,112 

applications (352 applicants times 6 

products per applicant) for products, on 

average, for each of the first three years. 

Of these, USDA estimates that 95 

percent will be approved for use of the 

label. 

5. In estimating the cost of the labor 

for reading the rule, completing 

applications, gathering and submitting 

information for posting on the 

BioPreferred Web site, and maintaining 

the applicable records, USDA used an 

average labor cost of $49.98 per hour. 

This hourly rate is based on the Federal 

salary schedule, step 6, GS 14 ‘‘rest of 

the United States’’ salary of $103,957 

per annum (with 2080 hours worked per 

annum). The salary level is deemed 

reasonable under the expectation that at 

least half the burden hours would likely 

be provided by private sector employees 

earning less than this hourly rate and up 

to half the private sector employees 

would be earning more. 

6. Based on the biobased content 

testing performed to support the item 

designation rulemakings, USDA 

estimated an average cost of $500 to 

perform biobased content testing. 

Estimated Burden 

During the first three years the 

labeling program is in effect, the total 

annual burden on all respondents is 

estimated to be $2,813,811. For the 

estimated 352 manufacturers/vendors 

(see item 3 above) certified to use the 

label, the average burden is, therefore, 

estimated to be $7,994 ($2,813,811 ÷ 352 

= $7,994). 

Abstract 

The Farm Security and Rural 

Investment Act of 2002 (2002 Act), as 

amended by the Food, Conservation, 

and Energy Act of 2008, established the 

Biobased Markets Program under Title 

IX, Section 9002. The 2002 Act requires 

the Secretary of Agriculture to create a 

voluntary labeling program for biobased 

products. 

The information requirements 

contained in this proposed rule require 

information from manufacturers and 

vendors of biobased products that seek 

to use the label on qualified biobased 

products. The information is vital for 

USDA to evaluate the qualifications of 

biobased products to carry the USDA 

label and to ensure that the label is used 

properly. This collection of information 

is necessary in order to implement the 

voluntary labeling program for biobased 

products established under the 2002 

Act. 

Copies of this information collection 

can be obtained from Ron Buckhalt at 

the following address: Ron Buckhalt, 

USDA, Office of the Assistant Secretary 

for Administration, Room 300, 

Reporters Building, 300 Seventh Street 

SW., Washington, DC 20024; e-mail: 

biopreferred@usda.gov; phone (202) 

205–4008. 

As part of our continuing effort to 

reduce paperwork and respondent 

burdens, USDA invites the public and 

other Federal agencies to comment on 

any aspect of the reporting burden in 

the proposed rule. Comments are 

invited on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of USDA in the operation and 

management of this labeling program; 

(2) the accuracy of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

through the use of appropriate 

automated, electronic, mechanical, or 

other technological collection 

techniques or other forms of information 

technology. Comments may be sent to: 

Office of Information and Regulatory 

Affairs of OMB, Attention: Desk Officer 

for Agriculture, Margaret Malanoski, 

725 17th Street, NW., Room 10202, 

Washington, DC 20503. Comments 

should reference OMB control number 

0503–NEW. All responses to this notice 

will be summarized and included in the 

request for OMB approval. All 

comments will also become a matter of 

public record. 

I. Government Paperwork Elimination 

Act Compliance 

USDA is committed to compliance 

with the Government Paperwork 

Elimination Act (GPEA) (44 U.S.C. 3504 

note), which requires Government 

agencies in general to provide the public 

the option of submitting information or 

transacting business electronically to 

the maximum extent possible. USDA is 

implementing an electronic information 

system for posting information 

submitted by manufacturers and 

vendors on the products they intend to 

label under the voluntary labeling 

program for biobased products. For 

information pertinent to GPEA 

compliance related to this rule, please 

contact Ron Buckhalt at (202) 205–4008. 


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J. Small Business Regulatory 

Enforcement Fairness Act 

The proposed rule is not a major rule 

under the Small Business Regulatory 

Enforcement Fairness Act, 5 U.S.C. 

804(2). This rule will not have an 

annual effect on the economy of $100 

million or more; will not cause a major 

increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; and 

does not have significant adverse effects 

on competition, employment, 

investment, productivity, innovation, or 

the ability of U.S.-based enterprises to 

compete with foreign-based enterprises. 

List of Subjects in 7 CFR Part 2904 

Biobased products, Labeling. 

For the reasons stated in the 

preamble, the U.S. Department of 

Agriculture (USDA) proposes to amend 

7 CFR chapter XXIX as follows: 

CHAPTER XXIX—DEPARTMENTAL 

ADMINISTRATION, DEPARTMENT OF 

AGRICULTURE 

1. A new part 2904 is added to 

chapter XXIX to read as follows: 

PART 2904—VOLUNTARY LABELING 

PROGRAM FOR BIOBASED 

PRODUCTS 

Sec. 

2904.1 Purpose and scope. 

2904.2 Definitions. 

2904.3 Applicability. 

2904.4 Criteria for product eligibility to use 

the label. 

2904.5 Initial approval process. 

2904.6 Appeals process. 

2904.7 Requirements for the use of the 

label. 

2904.8 Violations. 

2904.9 Recordkeeping requirements. 

2904.10 Oversight and monitoring. 

Authority: 7 U.S.C. 8102. 

§ 2904.1 Purpose and scope. 

The purpose of this part is to set forth 

the terms and conditions for voluntary 

use of the ‘‘USDA Certified Biobased 

Product’’ label. This part establishes the 

criteria that biobased products must 

meet in order to be eligible to become 

certified biobased products to which the 

‘‘USDA Certified Biobased Product’’ 

label can be affixed, the process 

manufacturers and vendors must use to 

obtain and maintain USDA certification, 

and the recordkeeping requirements for 

manufacturers and vendors who obtain 

certification. In addition, this part 

establishes specifications for the correct 

and incorrect uses of the label, which 

apply to manufacturers, vendors, and 

other entities. Finally, this part 

establishes actions that constitute 

voluntary labeling program violations. 

§ 2904.2 Definitions. 

Applicable minimum biobased 

content. The biobased content at or 

above the level set by USDA to qualify 

for use of the label. 

ASTM International (ASTM). A 

nonprofit organization that provides an 

international forum for the development 

and publication of voluntary consensus 

standards for materials, products, 

systems, and services. 

Biobased content. The amount of 

biobased carbon in the material or 

product expressed as a percent of 

weight (mass) of the total organic carbon 

in the material or product. For products 

within designated items, the biobased 

content shall be defined and determined 

as specified in the applicable section of 

subpart B of part 2902. For all other 

products, the biobased content is to be 

determined using ASTM Method D6866, 

Standard Test Methods for Determining 

the Biobased Content of Natural Range 

Materials Using Radiocarbon and 

Isotope Ratio Mass Spectrometry 

Analysis. 

Biobased product. A product 

determined by the Secretary to be a 

commercial or industrial product (other 

than food or feed) that is: 

(1) Composed, in whole or in 

significant part, of biological products, 

including renewable domestic 

agricultural materials and forestry 

materials; or 

(2) An intermediate ingredient or 

feedstock. For the purposes of this 

subpart, the term ‘biobased product’ 

does not include motor vehicle fuels, 

heating oil, electricity produced from 

biomass, or any mature market 

products. Products from a mature 

market will be determined on a case-bycase basis. 

Certified biobased product. A 

biobased product for which the 

manufacturer or vendor of the product 

has received approval from USDA to 

affix to the product the ‘‘USDA Certified 

Biobased Product’’ label. 

Days. As used in this part means 

calendar days. 

Designated item. For the purposes of 

this part means a generic grouping of 

biobased products designated for 

preferred procurement under subpart B 

of part 2902 of this title. 

Designated representative. An entity 

authorized by a manufacturer or vendor 

to affix the USDA label to the 

manufacturer’s or vendor’s certified 

biobased product or its packaging. 

Intermediate ingredients or 

feedstocks. A material or compound 

made in whole or in significant part 

from biological products, including 

renewable agricultural materials 

(including plant, animal, and marine 

materials) or forestry materials, that are 

subsequently used to make a more 

complex compound or product. For the 

purposes of this subpart, intermediate 

ingredients or feedstocks do not include 

raw agricultural or forestry materials, 

but represent those materials that can be 

put into a new cycle of production and 

finishing processes to create finished 

materials, ready for distribution and 

consumption. 

ISO. The International Organization 

for Standardization, a network of 

national standards institutes working in 

partnership with international 

organizations, governments, industries, 

business, and consumer representatives. 

ISO 9001 conformant. An entity that 

meets all of the requirements of the ISO 

9001 standard, but that is not required 

to be ISO 9001 certified. ISO 9001 refers 

to the International Organization for 

Standardization’s standards and 

guidelines relating to ‘‘quality 

management’’ systems. ‘‘Quality 

management’’ is defined as what the 

manufacturer does to ensure that its 

products or services satisfy the 

customer’s quality requirements and 

comply with any regulations applicable 

to those products or services. 

Label. Collectively, the label artwork 

(as defined in this section) and the 

biobased product statement(s), 

including the applicable biobased 

content(s). 

Label artwork. The certification 

marks, ‘‘USDA Certified Biobased 

Product’’ and the ‘‘USDA Certified 

Biobased Product’’ logo, and, where 

applicable, the letters ‘‘FP’’ to indicate 

that the product is within a designated 

item and eligible for Federal preferred 

procurement, as shown in Figure 1. 

Application of either certification mark 

by a manufacturer or vendor signifies 

that USDA has certified that the product 

meets the qualifications in this part. 


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Manufacturer. An entity that performs 

the necessary chemical and/or 

mechanical processes to make a final 

marketable product. 

Mature market products. Biobased 

products that are not eligible for 

designation for BioPreferred preferred 

procurement or labeling as defined 

under subpart B of part 2902 of this title 

because they had significant national 

market penetration in 1972. The 

eligibility of mature market products for 

the voluntary labeling program will be 

considered on a case-by-case basis, 

based on manufacturer’s or vendor’s 

appeal of the exclusion. 

Other entity. Any person, group, 

public or private organization, or 

business other than USDA, or 

manufacturers or vendors of biobased 

products that may wish to use the 

‘‘USDA Certified Biobased Product’’ 

label in informational or promotional 

material related to a certified biobased 

product. 

Program Manager. The manager of the 

BioPreferred Program. 

USDA. The United States Department 

of Agriculture. 

Vendor. An entity that offers for sale 

final marketable biobased products that 

are produced by manufacturers. 

§ 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 label in promoting the 

sales or the public awareness of certified 

biobased products. 

§ 2904.4 Criteria for product eligibility to 

use the label. 

A product must meet each of the 

criteria specified in paragraphs (a) and 

(b) of this section in order to be eligible 

to receive biobased product 

certification. 

(a) Biobased product. 

(1) Except as specified in paragraph 

(a)(2) of this section, the product for 

which certification is sought must be a 

biobased product as defined in § 2904.2 

of this part. 

(2) Products that meet the definition 

of mature market products, as defined in 

§ 2904.2 of this part, will be considered 

for certification only in those cases 

where the Program Manager sustains an 

appeal by the manufacturer or vendor of 

the product for inclusion in the 

voluntary labeling program, as specified 

in § 2904.6(c) of this part. 

(b) Minimum biobased content. The 

biobased content of the product must be 

equal to or greater than the applicable 

minimum biobased content, as 

described in paragraphs (b)(1) through 

(b)(4) of this section. 

(1) Biobased products within 

designated items. 

(i) Product is within a single 

designated item. If the product is within 

a single item that, at the time the 

application for certification is 

submitted, has been designated by 

USDA for preferred procurement, the 

applicable minimum biobased content 

is the minimum biobased content 

specified for the item as found in 

subpart B of 7 CFR part 2902. 

(ii) Product is within multiple 

designated items. If a biobased product 

is marketed within more than one 

designated item, uses the same 

packaging for each designated item, and 

the applicant seeks certification of the 

product, the product’s biobased content 

must meet or exceed the specified 

minimum biobased content for each of 

the applicable designated items in order 

to use the label on the product. 

However, if the manufacturer packages 

the product differently for each 

designated item then the applicable 

minimum biobased contents are those 

established under paragraph (b)(1)(i) of 

this section for each designated item for 

which the applicant seeks to use the 

label. 

(2) Finished biobased products that 

are not within designated items. 

(i) If the product is not an 

intermediate ingredient or feedstock and 

is not within a designated item at the 

time the application for certification is 

submitted, the applicable minimum 

biobased content is 51 percent. 

Manufacturers, vendors, groups of 

manufacturers and/or vendors, and 

trade associations may propose an 

alternative applicable minimum 

biobased content for the product by 

developing, in consultation with USDA, 

and conducting an analysis to support 

the proposed alternative applicable 

minimum biobased content. If approved 

by USDA, the proposed alternative 

applicable minimum biobased content 

would become the applicable minimum 

biobased content for the product. 

(ii) If a product certified under 

paragraph (2)(i) of this section is within 

an item that USDA subsequently 

designates for preferred procurement, 

the applicable minimum biobased 

content shall become, as of the effective 


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date of the final designation rule, the 

minimum biobased content specified for 

the item as found in subpart B of 7 CFR 

part 2902. 

(3) Products that are intermediate 

ingredients or feedstocks and are not 

within designated items. 

(i) If the product is an intermediate 

ingredient or feedstock that is not 

within a designated item at the time the 

application for certification is 

submitted, the applicable minimum 

biobased content is 51 percent. 

(ii) If a product certified under 

paragraph (3)(i) of this section is within 

an item that USDA subsequently 

designates for preferred procurement, 

the applicable minimum biobased 

content shall become, as of the effective 

date of the final designation rule, the 

minimum biobased content specified for 

the item as found in subpart B of 7 CFR 

part 2902. 

(4) [reserved] 

§ 2904.5 Initial approval process. 

(a) Application. Manufacturers and 

vendors seeking USDA certification to 

use the label for an eligible biobased 

product must submit a USDA-approved 

application for certification for each 

biobased product. A standardized 

application form and instructions are 

available on the USDA BioPreferred 

Web site (http://www.biopreferred.gov). 

The contents of an acceptable 

application are as specified in 

paragraphs (a)(1) through (3) of this 

section. 

(1) General content. The applicant 

must provide contact information and 

product information including all brand 

names or other identifying information, 

biobased content and testing 

information, product category, intended 

uses, and, if applicable, the 

corresponding designated item type. 

The applicant must attach to the 

application documentation 

demonstrating that the reported 

biobased content was tested by a thirdparty testing entity that is ISO 9001 

conformant. 

(2) Certifications. The applicant must 

certify in the application that the 

product for which use of the label is 

sought is a biobased product as defined 

in § 2904.2 of this part. 

(3) Commitments. The applicant must 

sign a statement in the application that 

commits the applicant to submitting to 

USDA the information specified in 

paragraph (c)(1) through (4) of this 

section, which USDA will post to the 

USDA BioPreferred Web site, and to 

providing USDA with up-to-date 

information for posting on this Web site. 

(b) Evaluation of applications. 

(1) USDA will evaluate each 

application to determine if it contains 

the information specified in paragraph 

(a) of this section. If USDA determines 

that the application is not complete, 

USDA will return the application to the 

applicant with an explanation of its 

deficiencies. Once the deficiencies have 

been addressed, the applicant may 

resubmit the application, along with a 

cover letter explaining the changes 

made, for re-evaluation by USDA. USDA 

will evaluate resubmitted applications 

separately from first-time applications, 

and those with the earliest original 

application submittal date will be given 

first priority. 

(2)(i) USDA will evaluate each 

complete application to determine 

compliance with the criteria specified in 

§ 2904.4. USDA will provide a written 

response to each applicant within 60 

days after the receipt of a complete 

application, informing the applicant of 

whether the application has been 

conditionally approved or has been 

disapproved. 

(ii) For those applications that are 

conditionally approved, a notice of 

certification, as specified in paragraph 

(c) of this section, must be issued before 

the use of the label can begin. 

(iii) For those applications that are 

disapproved, USDA will issue a notice 

of denial of certification and will inform 

the applicant in writing of each criterion 

not met. Applicants who receive a 

notice of denial of certification may 

appeal using the procedures specified in 

§ 2904.6. 

(c) Notice of certification. After 

notification that its application has been 

conditionally approved, the applicant 

must provide to USDA (for posting by 

USDA on the USDA BioPreferred Web 

site) the information specified in 

paragraphs (c)(1) through (4) of this 

section. Once USDA confirms that the 

information is received and complete, 

USDA will issue a notice of certification 

to the applicant. Upon receipt of a 

notice of certification, the applicant may 

begin using the label on the certified 

biobased product. 

(1) The product’s brand name(s), or 

other identifying information. 

(2) Contact information, including the 

name, mailing address, e-mail address, 

and telephone number of the applicant. 

(3) The biobased content of the 

product. 

(4) A hot link directly to the 

applicant’s Web site (if available). 

(d) Term of certification. 

(1) The effective date of certification 

is the date that the applicant receives a 

notice of certification from USDA. 

Except as specified in paragraphs (2)(i) 

through (2)(iv) of this section, 

certifications will remain in effect as 

long as the product is manufactured and 

marketed in accordance with the 

approved application and the 

requirements of this subpart. 

(2)(i) If the product formulation of a 

certified product is changed such that 

the biobased content of the product is 

reduced to a level below that reported 

in the approved application, the existing 

certification will not be valid for the 

product under the revised conditions 

and the manufacturer or vendor, as 

applicable, and its designated 

representatives must discontinue 

affixing the label to the product and 

must not initiate any further advertising 

of the product using the label. USDA 

will consider a product under such 

revised conditions to be a reformulated 

product, and the manufacturer or 

vendor, as applicable, must submit a 

new application for certification using 

the procedures specified in paragraph 

(a) of this section. 

(ii) If the product formulation of a 

certified product is changed such that 

the biobased content of the product is 

increased from the level reported in the 

approved application, and the 

manufacturer wishes to report the 

higher value on the label, a new 

application must be submitted using the 

procedures specified in paragraph (a) of 

this section. 

(iii) If the product formulation of a 

certified product is changed such that 

the biobased content of the product is 

increased, but the label is not revised, 

the existing certification will continue 

to be valid for the product. 

(iv) If the applicable required 

minimum biobased content for a 

product to be eligible to display the 

label is revised by USDA, manufacturers 

and vendors may continue to label their 

previously certified product only if it 

meets the new minimum biobased 

content level. In those cases where the 

biobased content of a certified product 

fails to meet the new minimum 

biobased content level, USDA will 

notify the manufacturer or vendor that 

their certification is no longer valid. 

Such manufacturers and vendors must 

increase the biobased content of their 

product to a level at or above the new 

minimum biobased content level and 

must re-apply for certification within 60 

days if they wish to continue to use the 

label. Manufacturers and vendors who 

have re-applied for certification may 

continue using the existing label until 

they receive notification from USDA on 

the results of their re-application for 

certification. 


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§ 2904.6 Appeal processes. 

An applicant for certification may 

appeal a notice of denial of certification 

to the Program Manager. Entities that 

have received a notice of violation, and 

manufacturers and vendors of certified 

biobased products who have received a 

notice of suspension or revocation, may 

appeal to the Program Manager. 

Manufacturers and vendors of mature 

market products may appeal the 

exclusion of their products from the 

voluntary labeling program to the 

Program Manager. 

(a)(1) Appeals to the Program Manager 

must be filed within 30 days of receipt 

by the appellant of a notice of denial of 

certification, a notice of violation, a 

notice of suspension, or a notice of 

revocation. Appeals must be filed in 

writing and addressed to: Program 

Manager, USDA Voluntary Labeling 

Program for Biobased Products, Room 

300, Reporters Building, 300 Seventh 

Street SW., Washington, DC 20024. 

(2) All appeals must include a copy of 

the adverse decision and a statement of 

the appellant’s reasons for believing that 

the decision was not made in 

accordance with applicable program 

regulations, policies, or procedures, or 

otherwise was not proper. 

(b)(1) If the Program Manager sustains 

an applicant’s appeal of a notice of 

denial of certification, USDA will issue 

a notice of certification to the applicant 

for its biobased product. 

(2) If the Program Manager sustains a 

manufacturer’s or vendor’s appeal of a 

notice of violation, USDA will rescind 

the notice and no further action will be 

taken by USDA. 

(3) If the Program Manager sustains a 

manufacturer’s or vendor’s appeal of a 

notice of suspension, the manufacturer, 

vendors, and their designated 

representative(s) may immediately 

resume affixing the label to the certified 

biobased product and USDA will 

reinstate the product’s information to 

the USDA BioPreferred Web site. 

(4) If the Program Manager sustains a 

manufacturer’s or vendor’s appeal of a 

notice of revocation, the manufacturer 

or vendor, and its designated 

representatives may immediately 

resume affixing the label to the certified 

biobased product and sell and distribute 

the certified biobased product with the 

label. In addition, USDA will reinstate 

the product’s information to the USDA 

BioPreferred Web site. 

(c)(1) Manufacturers or vendors of 

mature market products may appeal the 

exclusion of their products from the 

voluntary labeling program if they 

believe that special conditions or 

circumstances warrant the inclusion of 

their products in the program. Appeals 

to the Program Manager from 

manufacturers or vendors of mature 

market products must be filed in writing 

and addressed to: Program Manager, 

USDA Voluntary Labeling Program for 

Biobased Products, Room 300, Reporters 

Building, 300 Seventh Street, SW., 

Washington, DC 20024. 

(2) Appeals for the inclusion of 

mature market products must include 

detailed justification showing why the 

product should be allowed to use the 

label. 

(3) If the Program Manager sustains a 

manufacturer’s or vendor’s appeal of its 

product’s exclusion from the program, 

the manufacturers or vendors may then 

apply for certification to use the label on 

that product, as specified in § 2904.5(a) 

of this part. 

(4) Mature market products that are 

certified by USDA to use the label will 

be considered to be ‘‘finished biobased 

products that are not within designated 

items’’ and subject to all provisions of 

this part that are applicable to that 

category of certified biobased products. 

(d) Appeals of any of the Program 

Manager’s decisions may be made to the 

USDA Assistant Secretary for 

Administration. Appeals must be made, 

in writing, within 30 days of receipt of 

the Program Manager’s decision and 

addressed to: Assistant Secretary for 

Administration, Room 209A, Whitten 

Building, 1400 Independence Avenue, 

SW., Washington, DC 20250–0103. If the 

Assistant Secretary for Administration 

sustains an appeal, the provisions of 

paragraph (b) of this section will apply. 

§ 2904.7 Requirements associated with the 

label. 

(a) Who may use the label? 

(1) Manufacturers and vendors. Only 

manufacturers and vendors who have 

received a notice of certification, or 

designated representatives of the 

manufacturer or vendor, may affix the 

label to the product or its packaging. A 

manufacturer or vendor who has 

received a notice of certification for a 

product under this part: 

(i) May use the label on the product, 

its packaging, and other related 

materials including, but not limited to, 

advertisements, catalogs, procurement 

databases, promotional material, Web 

sites, or user manuals for that product, 

according to the requirements set forth 

in this section; and 

(ii) is responsible for the manner in 

which the label is used by its 

companies, as well as its designated 

representatives, including advertising 

agencies and subcontractors. 

(2) Other entities. 

(i) Other entities may use the label to 

advertise or promote certified biobased 

products in materials including, but not 

limited to, advertisements, catalogs, 

procurement databases, Web sites, and 

promotional and educational materials, 

as long as the manufacturer or vendor of 

the product, or one of their designated 

representatives, has affixed the label to 

the product or its packaging. 

(ii) Other entities may use the label 

and the BioPreferred Program name in 

general statements as described in 

paragraph (b) of this section, as long as 

the statements do not imply that a noncertified biobased product is certified. 

(b) Correct usage of the label. 

(1) The label can be affixed only to 

certified biobased products and their 

associated packaging. 

(2) The label may be used in material 

including, but not limited to, 

advertisements, catalogs, procurement 

databases, Web sites, and promotional 

and educational materials to distinguish 

products that are certified for use of the 

label from those that are not certified. 

The label may be used in 

advertisements for both certified 

biobased products and non-certified 

products if the advertisement clearly 

indicates which products are certified. 

Care must be taken to avoid implying 

that any non-certified products are 

certified. 

(3) The label may be used without 

reference to a specific certified biobased 

product only when informing the public 

about the purpose of the label. For 

example, the following or similar claim 

is acceptable: ‘‘Look for the ‘USDA 

Certified Biobased Product’ label. It 

means that the product meets USDA 

standards for the amount of biobased 

content and the manufacturer or vendor 

has provided relevant information on 

the product for the USDA BioPreferred 

Web site.’’ This exception allows 

manufacturers, vendors, and other 

entities to use the label in documents 

such as corporate reports, but only in an 

informative manner, not as a statement 

of product certification. 

(4) The label may appear next to a 

picture of the product(s) or text 

describing it. 

(5) The label must stand alone and not 

be incorporated into any other label or 

logo designs. 

(6) The label may be used as a 

watermark provided the use does not 

violate any usage restrictions specified 

in this part. 

(7) The text portion of the label must 

be written in English and may not be 

translated, even when the label is used 

outside of the United States. 

(c) Incorrect usage of the label. 

(1) The label shall not be used on any 

product that has not been certified by 


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USDA as a ‘‘USDA Certified Biobased 

Product.’’ 

(2) The label shall not be used on any 

advertisements or informational 

materials where both certified biobased 

products and non-certified products are 

shown unless it is clear that the label 

applies to only the certified biobased 

product(s). 

(3) The label shall not be used to 

imply endorsement by USDA or the 

BioPreferred Program of any particular 

product, service, or company. 

(4) The label shall not be used in any 

form that could be misleading to the 

consumer. 

(5) The label shall not be used by 

manufacturers or vendors of certified 

products in a manner disparaging to 

USDA or any other government body. 

(6) The label shall not be used with 

an altered label or incorporated into 

other label designs. 

(7) The label shall not be used on 

business cards, company letterhead, or 

company stationery. 

(8) The label shall not be used in, or 

as part of, any company name, logo, 

product name, service, or Web site, 

except as may be provided for in this 

part. 

(9) The label shall not be used in a 

manner that violates any of the 

applicable requirements contained in 

this part. 

(d) Imported products. The label can 

be used only with a product that is 

certified by USDA under this part. The 

label cannot be used to imply that a 

product meets or exceeds the 

requirements of biobased programs in 

other countries. Products imported for 

sale in the U.S. must adhere to the same 

guidelines as U.S.-sourced biobased 

products. Any product sold in the U.S. 

as a ‘‘USDA Certified Biobased Product’’ 

must have received certification from 

USDA. 

(e) Contents of the label. The label 

shall consist of the items specified in 

paragraphs (e)(1) through (3) of this 

section, as applicable. 

(1) The label artwork provided by the 

BioPreferred Program. 

(2) The biobased content and 

applicable biobased product 

statement(s), as specified in paragraph 

(f)(2) of this section. 

(3) The USDA BioPreferred Web site 

address must also be included on, or in 

close proximity to, the label. 

(f) Physical aspects of the label. 

(1) Label artwork. The label artwork 

may not be altered, cut, separated into 

components, or distorted in appearance 

or perspective. Labels that are applied to 

biobased products that have been 

designated for preferred procurement 

will include the letters ‘‘FP’’ as part of 

the label artwork. The label must appear 

only in the colors specified in 

paragraphs (f)(1)(i) through (iii) of this 

section, unless approval is given by 

USDA for an exception. 

(i) The three-color version of the label 

is preferred. The colors used must be 

Pantone-White, Pantone 356C, and 

Pantone 362C. 

(ii) A one-color version of the label 

may be substituted for the three-color 

version as long as one of the following 

colors is used: Pantone 356C or Pantone 

362C. 

(iii) A black and white version of the 

label is acceptable. 

(2) Biobased content and applicable 

biobased product statement(s). The 

biobased content and applicable 

biobased product statement(s) must be 

placed directly below the label artwork 

and must be displayed in a manner that 

makes it easily readable. 

(i) One or both of the following two 

statements, as applicable, must be used 

to identify the product to which the 

label applies: 

(A) Product: XX% biobased. 

(B) Packaging: XX% biobased. 

(ii) The biobased content reported in 

the biobased product statement(s) 

specified in paragraphs (f)(2)(i)(A) and 

(B) of this section shall be expressed as 

‘‘XX%,’’ where XX% represents the 

actual biobased content of the product 

or packaging. The biobased content 

displayed at the time the label is affixed 

to the product or its packaging must be 

the same as the biobased content 

specified in the most recent approved 

application for the certified biobased 

product. 

(3) The USDA BioPreferred Web site 

address must be included either on the 

label, below the product statement, if 

space allows or in close proximity to the 

label on the product or packaging. 

(g) Placement of the label. 

(1) The label can appear directly on a 

product, its associated packaging, in 

user manuals, and in other materials 

including, but not limited to, 

advertisements, catalogs, procurement 

databases, and promotional and 

educational materials. 

(2) The label shall not be placed in a 

manner that is ambiguous about which 

product is a certified biobased product 

or that could indicate certification of a 

non-certified product. 

(3) When used to distinguish a 

certified biobased product in material 

including, but not limited to, 

advertisements, catalogs, procurement 

databases, Web sites, and promotional 

and educational materials, the label 

must appear near a picture of the 

product or the text describing it. 

(i) If all products on a page are 

certified biobased products, the label 

may be placed anywhere on the page. 

(ii) If a page contains a mix of 

certified biobased products and noncertified products, the label shall be 

placed in close proximity to the 

certified biobased products. An 

individual label near each certified 

biobased product may be necessary to 

avoid confusion. 

(h) Minimum size and clear space 

recommendations for the label. 

(1) The label may be sized to fit the 

individual application as long as the 

correct proportions are maintained and 

the label remains legible. 

(2) A border of clear space must 

surround the label and must be of 

sufficient width to offset it from 

surrounding images and text and to 

avoid confusion. If the label’s color is 

similar to the background color, an 

outlining color may be used to enhance 

contrast. 

(i) Where to obtain copies of the label 

artwork. The label artwork is available 

at the USDA BioPreferred Web site. 

§ 2904.8 Violations. 

This section identifies the types of 

actions that USDA considers violations 

under this part and the penalties (e.g., 

the suspension or revocation of 

certification) associated with such 

violations. 

(a) General. Violations under this 

section occur on a per product basis and 

the penalties are to be applied on a per 

product basis. Entities cited for a 

violation under this section may appeal 

using the provisions in § 2904.6. If 

certification for a product is revoked, 

the manufacturer or vendor whose 

certification has been revoked may seek 

re-certification for the product using the 

procedures specified under the 

provisions in § 2904.5. 

(b) Types of violations. Actions that 

will be considered violations of this part 

include, but are not limited to, the 

following specific examples: 

(1) Biobased content violations. The 

Program Manager will utilize occasional 

random testing of certified biobased 

products to compare the biobased 

content of the tested product with the 

product’s applicable minimum biobased 

content and the biobased content 

reported by the manufacturer or vendor 

in its approved application. Such testing 

will be conducted using ASTM Method 

D6866. USDA will provide a copy of the 

results of its testing to the applicable 

manufacturer or vendor. 

(i) If USDA testing shows that the 

biobased content of a certified biobased 

product is less than its applicable 


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minimum biobased content, then a 

violation of this part will have occurred. 

(ii) If USDA testing shows that the 

biobased content is less than that 

reported by the manufacturer or vendor 

in its approved application, but is still 

equal to or greater than its applicable 

minimum biobased content(s), USDA 

will provide written notification to the 

manufacturer or vendor. The 

manufacturer or vendor must submit, 

within 30 days from receipt of USDA 

written notification, a new application 

for the lower biobased content. Failure 

to submit a new application within 30 

days will be considered a violation of 

this part. 

(A) The manufacturer or vendor can 

submit in the new application the 

biobased content reported to it by USDA 

in the written notification. 

(B) Alternatively, the manufacturer or 

vendor may elect to retest the product 

in question and submit the results of the 

retest in the new application. If the 

manufacturer or vendor elects to retest 

the product, it must test a sample of the 

current product. 

(2) Label violations. 

(i) Any usage or display of the label 

that does not conform to the 

requirements specified in § 2904.7. 

(ii) Affixing the label to any product 

prior to issuance of a notice of 

certification from USDA. 

(iii) Affixing the label to a certified 

biobased product during periods when 

certification has been suspended or 

revoked. 

(3) Application violations. Knowingly 

providing false or misleading 

information in any application for 

certification of a biobased product 

constitutes a violation of this part. 

(4) USDA BioPreferred Web site 

violations. Failure to provide to USDA 

updated information when the 

information for a certified biobased 

product becomes outdated or when new 

information for a certified biobased 

product becomes available constitutes a 

violation of this part. 

(c) Notice of violations and associated 

actions. USDA will provide the 

applicable manufacturer or vendor or 

their designated representatives and any 

involved other entity known to USDA 

written notification of any violations 

identified by USDA. Entities who 

receive a notice of violation for a 

biobased content violation must correct 

the violation(s) within 30 days from 

receipt of the notice of violation. 

Entities who receive a notice of 

violation for other types of violations 

must correct the violation(s) within 60 

days from receipt of the notice of 

violation. If the entity receiving a notice 

of violation is a manufacturer, a vendor, 

or a designated representative of a 

manufacturer or vendor, USDA will 

pursue notices of suspensions and 

revocation, as discussed in paragraphs 

(c)(1) and (c)(2) of this section. USDA 

reserves the right to further pursue 

action against these entities as provided 

for in paragraph (c)(3) of this section. If 

the entity receiving a notice of violation 

is an ‘‘other entity’’ (i.e., not a 

manufacturer, vendor, or designated 

representative), then USDA will pursue 

action according to paragraph (c)(3) of 

this section. Entities that receive notices 

of suspension or revocation may appeal 

such notices using the procedures 

specified in § 2904.6. 

(1) Suspension. 

(i) If a violation is applicable to a 

manufacturer, vendor, or designated 

representative and the applicable entity 

fails to make the required corrections 

within 30 days (for biobased content 

violations) or 60 days (for other types of 

violations) of receipt of a notice of 

violation, USDA will notify the 

manufacturer or vendor, as appropriate, 

of the continuing violation, and the 

USDA certification for that product will 

be suspended. As of the date that the 

manufacturer or vendor receives a 

notice of suspension, the manufacturer 

or vendor and their designated 

representatives must not affix the label 

to any of that product, or associated 

packaging, not already labeled and must 

not distribute any additional products 

bearing the label. USDA will issue a 

press release informing the public of the 

suspension and will also remove the 

product information from the USDA 

BioPreferred Web site. 

(ii) If, within 30 days from receipt of 

the notice of suspension, the 

manufacturer or vendor whose USDA 

product certification has been 

suspended makes the required 

corrections and notifies USDA that the 

corrections have been made, the 

manufacturer or vendor and their 

designated representatives may, upon 

receipt of USDA approval of the 

corrections, resume use of the label. 

USDA will also restore the product 

information to the USDA BioPreferred 

Web site. 

(2) Revocation. 

(i) If a manufacturer or vendor whose 

USDA product certification has been 

suspended fails to make the required 

corrections and notify USDA of the 

corrections within 30 days of the date of 

the suspension, USDA will notify the 

manufacturer or vendor that the 

certification for that product is revoked. 

(ii) As of the date that the 

manufacturer or vendor receives the 

notice revoking USDA certification, the 

manufacturer or vendor and their 

designated representatives must not 

affix the label to any of that product not 

already labeled. In addition, the 

manufacturer or vendor and their 

designated representatives are 

prohibited from further sales of product 

to which the label is affixed. 

(iii) If a manufacturer or vendor 

whose product certification has been 

revoked wishes to use the label, the 

manufacturer or vendor must follow the 

procedures required for original 

certification. 

(3) Other remedies. In addition to the 

suspension or revocation of the 

certification to use the label, depending 

on the nature of the violation, USDA 

may pursue suspension or debarment of 

the entities involved in accordance with 

part 3017 of this title. USDA further 

reserves the right to pursue any other 

remedies available by law, including 

any civil or criminal remedies, against 

any entity that violates the provisions of 

this part. 

§ 2904.9 Recordkeeping requirements. 

(a) Records. Manufacturers and 

vendors shall maintain records 

documenting compliance with this part 

for each product that has received 

certification to use the label, as 

specified in paragraphs (a)(1) through 

(3) of this section. 

(1) The results of all tests, and any 

associated calculations, performed to 

determine the biobased content of the 

product. 

(2) The date the applicant receives 

certification from USDA, the dates of 

changes in formulation of certified 

biobased products, and the dates when 

the biobased content of certified 

biobased products was tested. 

(3) Documentation of analyses 

performed by manufacturers to support 

claims of environmental or human 

health benefits, life cycle cost, 

sustainability benefits, and product 

performance made by the manufacturer. 

(b) Record retention. For each 

certified biobased product, records kept 

under paragraph (a) of this section must 

be maintained for at least three years 

beyond the end of the label certification 

period (i.e., three years beyond the 

period of time when manufacturers and 

vendors cease using the label). Records 

may be kept in either electronic format 

or hard copy format. All records kept in 

electronic format must be readily 

accessible during a USDA audit. 

§ 2904.10 Oversight and monitoring. 

(a) General. USDA will conduct 

oversight and monitoring of 

manufacturers, vendors, designated 

representatives, and other entities 

involved with the voluntary labeling 


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Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Proposed Rules 38317 

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 § 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 § 2904.9 for 

inspection and copying during normal 

Federal business hours. 

Dated: July 17, 2009. 

Pearlie S. Reed, 

Assistant Secretary for Administration, U.S. 

Department of Agriculture. 

[FR Doc. E9–17610 Filed 7–30–09; 8:45 am] 

BILLING CODE 3410–93–P 


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