Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15021 

Programs commences on October 1 of 

each calendar year. The rate for 

laboratory services is $60.00 per hour in 

fiscal year 2007, $63.00 per hour in 

fiscal year 2008, and $67.00 per hour in 

fiscal year 2009. 

(b) Printed updated schedules of the 

laboratory testing fees for processed 

fruits and vegetables (7 CFR part 93), 

poultry and egg products (7 CFR part 

94), and meat and meat products (7 CFR 

part 98) will be available for distribution 

to Science and Technology’s 

constituents and stakeholders by the 

individual Laboratory Managers of 

Science and Technology laboratories 

listed in § 91.5. These single test 

laboratory fee schedules are based upon 

the applicable hourly fee rate stated in 

§ 91.37(a). 

(c) Except as otherwise provided in 

this section, charges will be made at the 

applicable hourly rate stated in 

§ 91.37(a) for the time required to 

perform the service. A charge will be 

made for service pursuant to each 

request or certificate issued. 

(d) When a laboratory test service is 

provided for AMS by a commercial or 

State government laboratory, the 

applicant will be assessed a fee which 

covers the costs to the Science and 

Technology program for the service 

provided. 

(e) When Science and Technology 

staff provides applied and 

developmental research and training 

activities for microbiological, physical, 

chemical, and biomolecular analyses on 

agricultural commodities the applicant 

will be charged a fee on a reimbursable 

cost to AMS basis. 

■ 4. Section 91.38 is revised to read as 

follows: 

§ 91.38 Additional fees for appeal of 

analysis. 

(a) The applicant for appeal sample 

testing will be charged a fee at the 

hourly rate for laboratory service that 

appears in this paragraph. The new 

fiscal year for Science and Technology 

Programs commences on October 1 of 

each calendar year. The appeal rate for 

laboratory service is $71.00 per hour in 

fiscal year 2007, $74.00 per hour in 

fiscal year 2008, and $78.00 per hour in 

fiscal year 2009. 

(b) The appeal fee will not be waived 

for any reason if analytical testing was 

completed in addition to the original 

analysis. 

■ 5. Section 91.39 is revised to read as 

follows: 

§ 91.39 Premium hourly fee rates for 

overtime and legal holiday service. 

(a) When analytical testing in a 

Science and Technology facility 

requires the services of laboratory 

personnel beyond their regularly 

assigned tour of duty on any day or on 

a day outside the established schedule, 

such services are considered as overtime 

work. When analytical testing in a 

Science and Technology facility 

requires the services of laboratory 

personnel on a Federal holiday or a day 

designated in lieu of such a holiday, 

such services are considered holiday 

work. Laboratory analyses initiated at 

the request of the applicant to be 

rendered on Federal holidays, and on an 

overtime basis will be charged fees at 

hourly rates for laboratory service that 

appear in this paragraph. The new fiscal 

year for Science and Technology 

Programs commences on October 1 of 

each calendar year. The laboratory 

analysis rate for overtime service is 

$71.00 per hour in fiscal year 2007, 

$74.00 per hour in fiscal year 2008, and 

$78.00 per hour in fiscal year 2009. The 

laboratory analysis rate for Federal 

holiday or designed holiday service is 

$82.00 per hour in fiscal year 2007, 

$85.00 per hour in fiscal year 2008, and 

$89.00 per hour in fiscal year 2009. 

(b) Information on legal holidays or 

what constitutes overtime service at a 

particular Science and Technology 

laboratory is available from the 

Laboratory Manager or facility 

supervisor. 

■ 6. Section 91.42 is revised to read as 

follows: 

§ 91.42 Billing. 

(a) Each billing cycle will end on the 

25th of the month. The applicant will be 

billed by the National Finance Center 

(NFC) using the Foundation Financial 

Information System (FFIS) on the 1st 

day, following the end of the billing 

cycle in which voluntary laboratory 

services and other services were 

rendered at a particular Science and 

Technology laboratory or office. 

(b) The total charge or fee shall 

normally be stated directly on the 

analysis report or on a standardized 

official certificate form for the 

laboratory analysis of a specific 

agricultural commodity and related 

commodity products. 

(c) The actual bill for collection will 

be issued by the USDA, National 

Finance Center Billings and Collection 

Branch, (Mail: P.O. Box 60075), 13800 

Old Gentilly Road, New Orleans, 

Louisiana 70160–0001. 

PART 92—[REMOVED AND 

RESERVED] 

■ 7. Part 92 is removed and reserved. 

Dated: March 23, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E7–5787 Filed 3–29–07; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 981 

[Docket No. FV06–981–1 FR] 

Almonds Grown in California; 

Outgoing Quality Control 

Requirements 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This rule adds outgoing 

quality control requirements under the 

administrative rules and regulations of 

the California almond marketing order 

(order). The order regulates the handling 

of almonds grown in California and is 

administered locally by the Almond 

Board of California (Board). This rule 

provides for a mandatory program under 

the order to reduce the potential for 

Salmonella bacteria in almonds. This 

action will help ensure that quality 

almonds are available for human 

consumption. 

DATES: This rule is effective on March 

31, 2007. Handler treatment plans for 

the 2007–08 crop year must be 

submitted by May 31, 2007. Mandatory 

compliance with this rule begins 

September 1, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Maureen T. Pello, Assistant Regional 

Manager, or Kurt J. Kimmel, Regional 

Manager, California Marketing Field 

Office, Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, Telephone: (559) 487–

5901, Fax: (559) 487–5906, or E-mail: 

Maureen.Pello@usda.gov, or 

Kurt.Kimmel@usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Jay Guerber, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; Telephone: (202) 720–

2491, Fax: (202) 720–8938, or E-mail: 

Jay.Guerber@usda.gov. 

SUPPLEMENTARY INFORMATION: This final 

rule is issued under Marketing Order 

No. 981, as amended (7 CFR part 981), 

regulating the handling of almonds 

grown in California, hereinafter referred 


cprice-sewell on PROD1PC66 with RULES
15022 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

to as the ‘‘order.’’ The order is effective 

under the Agricultural Marketing 

Agreement Act of 1937, as amended (7 

U.S.C. 601–674), hereinafter referred to 

as the ‘‘Act.’’

The Department of Agriculture 

(USDA) is issuing this rule in 

conformance with Executive Order 

12866. 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule is not intended to 

have retroactive effect. This rule will 

not preempt any State or local laws, 

regulations, or policies, unless they 

present an irreconcilable conflict with 

this rule. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 

with USDA a petition stating that the 

order, any provision of the order, or any 

obligation imposed in connection with 

the order is not in accordance with law 

and request a modification of the order 

or to be exempted therefrom. Such 

handler is afforded the opportunity for 

a hearing on the petition. After the 

hearing USDA would rule on the 

petition. The Act provides that the 

district court of the United States in any 

district in which the handler is an 

inhabitant, or has his or her principal 

place of business, has jurisdiction to 

review USDA’s ruling on the petition, 

provided an action is filed not later than 

20 days after the date of the entry of the 

ruling. 

This final rule adds outgoing quality 

control requirements under the 

administrative rules and regulations of 

the order. This rule provides for a 

mandatory program to reduce the 

potential for Salmonella bacteria in 

almonds. This action will help ensure 

that quality almonds are available for 

human consumption. This action was 

unanimously recommended by the 

Board at a meeting on August 22, 2006. 

Section 981.42(b) of the order 

provides authority for the Board to 

establish, with approval of the 

Secretary, such minimum quality and 

inspection requirements applicable to 

almonds to be handled or to be 

processed into manufactured products, 

as will contribute to orderly marketing 

or be in the public interest. In such crop 

year, no handler shall handle or process 

almonds into manufactured items or 

products unless they meet the 

applicable requirements as evidenced 

by certification acceptable to the Board. 

The Board, with approval of the 

Secretary, may establish rules and 

regulations necessary and incidental to 

the administration of this provision. 

Salmonella Outbreaks Linked to 

Almonds 

In 2001, a Salmonella outbreak was 

identified in Canada, which was linked 

to a specific retailer, traced back to raw 

almonds sold in bulk bins, and 

ultimately traced back to the handler 

and the grower. The Salmonella strain 

was extremely unusual and had not 

previously been associated with 

contamination in a non-animal product. 

Three orchards where the almonds were 

produced were identified, and samples 

gathered from the orchards contained 

Salmonella. With oversight by the 

California Department of Health 

Services (CDHS), procedures were 

implemented by the grower, huller/ 

sheller, and handler to specify how the 

almonds from those orchards were to be 

processed using a treatment to reduce 

the potential for Salmonella before the 

almonds were moved into commercial 

channels. The Board initiated an 

extensive research program to help 

understand the occurrence of 

Salmonella in almond orchards. 

The Board also initiated an education 

program for the industry regarding Good 

Agricultural Practices (GAPs), Good 

Manufacturing Practices (GMPs), and 

Sanitation Standard Operating 

Procedures (SSOPs). GAPs provide 

guidelines to growers on how to 

minimize potential biological hazards 

during the production and harvesting of 

almonds. GMPs define procedures to be 

used by handlers to allow almonds to be 

processed, packed, and sold under 

sanitary conditions. SSOPs help to 

ensure a clean and sanitary environment 

in the packing facility. Together, these 

practices and procedures provide a 

framework for a Hazard Analysis 

Critical Control Point (HACCP) program 

for the industry to proactively eliminate 

or minimize potential sources of 

Salmonella contamination. 

In the spring of 2004, a second 

Salmonella outbreak occurred in Oregon 

that was linked to raw almonds 

purchased at a particular retailer. The 

Salmonella strain was very similar to 

that identified in 2001. One handler had 

been the supplier to the retailer, and the 

handler initiated a voluntary recall of 5 

million pounds of almonds sold in the 

U.S. The Food and Drug Administration 

(FDA) subsequently announced that the 

almonds had been exported to eight 

countries. The handler then initiated a 

full recall of the suspect almonds 

produced, packed, and shipped, 

increasing the recall to approximately 

15 million pounds. 

In the summer of 2004, the Board 

unanimously approved a voluntary 

action plan that called for treating all 

almonds to reduce the potential for 

Salmonella. Handlers were encouraged 

to treat the almonds prior to shipment, 

or ship the almonds to a manufacturer 

who agreed to treat the almonds. The 

Board continued to fund research on 

various technologies that could be used 

to help reduce the potential for 

Salmonella in almonds. 

Board Recommendation for a 

Mandatory Treatment Program 

To further its efforts in providing a 

high quality product to consumers, in 

August 2006, the Board recommended 

that a mandatory treatment program be 

implemented under the order, pursuant 

to authority provided in § 981.42(b). 

Specifically, handlers must subject their 

almonds to a process that achieves a 

minimum 4-log reduction in Salmonella 

bacteria prior to shipment. The program 

provides for an exemption for handlers 

who ship untreated almonds under a 

direct verifiable (DV) program to 

manufacturers within the U.S., Canada, 

or Mexico who agree to treat the 

almonds accordingly. The program also 

provides for an exemption for handlers 

who ship untreated almonds to 

locations outside of the U.S., Canada, or 

Mexico. All containers of untreated 

almonds shipped under the two 

exemptions must be prominently 

identified with the term 

‘‘unpasteurized.’’

Specific Parameters of Mandatory 

Program 

Under the program, handlers must 

subject their almonds to a treatment 

process or processes that achieve in 

total a minimum 4-log reduction of 

Salmonella bacteria, or ship their 

almonds under one of the two 

exemptions cited above. The rule only 

affects those who meet the definition of 

‘‘handler’’ in § 981.13 of the order (thus 

exempting growers selling through 

roadside stands). Log reduction 

describes how much bacterial 

contamination is reduced by a treatment 

process. A 4-log reduction decreases 

bacteria by a factor of 10,000 (4 zeros). 

One treatment process that 

independently achieves a minimum 4- 

log reduction may be used, or a 

combination of different treatments may 

be used that collectively achieve a 

minimum 4-log reduction (‘‘hurdle’’

technologies). 

The Board initially supported a 5-log 

reduction, which is FDA’s performance 

standard. However, the Board 

subsequently funded research with the 

University of California, Davis, in 

conjunction with Rutgers University, 

whereby a risk assessment model was 

developed using data from the two 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15023 

1 Journal of Food Protection, Vol. 69, No. 7, 2006, 

Pages 1594–1599. 

Salmonella outbreaks, as well as data 

from an industry pathogen survey.1 The 

risk assessment model demonstrated 

that a minimum 4-log reduction 

provides an appropriate level of 

consumer protection. Thus, the Board 

concluded that a 4-log reduction was an 

appropriate standard for almonds. 

Treatment Processes 

Treatment processes for handlers 

must utilize technologies that have been 

determined to achieve a minimum 4-log 

reduction of Salmonella bacteria in 

almonds, pursuant to a letter of 

determination issued by the FDA, or 

acceptance by a scientific review panel 

as identified by the Board (known as the 

Technical Expert Review Panel, or 

TERP). 

The FDA reviews studies utilizing 

specific protocols and treatment 

parameters, and issues a letter of 

determination when it determines that a 

process has sufficiently demonstrated 

its effectiveness to achieve a 5-log 

reduction of Salmonella in almonds. Todate, FDA has issued letters of 

determination for propylene oxide 

(PPO), oil roasting, blanching, and for a 

moist heat process. 

The TERP will evaluate various 

treatment technologies against specific 

criteria, based on recommendations 

provided by the National Advisory 

Committee on Microbiological Criteria 

in Food (NACMCF). The NACMCF was 

formed in 1988 under Departmental 

Regulation 1043–28, and provides 

impartial, scientific advice to Federal 

food safety agencies for use in the 

development of an integrated national 

food safety systems approach from farm 

to final consumption to assure the safety 

of domestic, imported, and exported 

foods. It is co-sponsored by USDA’s 

Food Safety and Inspection Service, the 

FDA, the Center for Disease Control and 

Prevention, the National Marine 

Fisheries Service, and the Department of 

Defense Veterinary Service Activity. 

While the TERP will not 

‘‘recommend’’ or ‘‘approve’’

technologies, its review will ensure that 

technologies utilized by the industry 

have been evaluated against specific 

science-based criteria demonstrating the 

technology’s ability to deliver a lethal 

treatment for Salmonella in almonds. 

Documentation and data must be 

provided to the TERP (by a company 

pursuing TERP acceptance for its 

technology) for review to ensure that the 

technologies are consistently achieving 

the minimum 4-log reduction. 

The TERP, initially formed by the 

Board in the fall of 2004 to review 

treatment technologies, consists of four 

scientists, with a representative from the 

FDA serving as an ex-officio member. 

The TERP has been evaluating various 

technologies and treatments for the 

almond industry, and to-date, the TERP 

has accepted steam and moist heat 

treatments as acceptable for achieving 

the Board’s Salmonella reduction goals. 

Membership on the TERP must be 

approved annually by the Board prior to 

the beginning of each crop year, or more 

frequently if needed during the crop 

year, for example, to fill a vacancy on 

the panel. 

On-Site Versus Off-Site Treatment 

Under the program, unless handlers 

ship their almonds to a Board-approved 

DV user (described later in this 

document), or ship their almonds to 

locations outside of the U.S., Canada, or 

Mexico, handlers must subject their 

almonds to a treatment process or 

processes prior to shipment either at 

their handling facility (on-site), or at an 

off-site treatment facility located within 

the production area (California). An offsite facility may or may not be affiliated 

with another handler. Transportation of 

almonds by a handler to an off-site 

treatment facility will not be considered 

a shipment. 

Process Authorities 

Handlers may only use, or transport 

their almonds to off-site treatment 

facilities that use treatment processes 

that have been ‘‘validated’’ by a Boardapproved process authority. Validation 

means that the treatment technology 

and equipment utilized have been 

demonstrated to achieve the minimum 

4-log reduction. The use of process 

authorities is modeled after process 

authorities as cited in the ‘‘Guide to 

Inspections of Low Acid Canned Food 

Manufacturers’’ (Guide) (http:// 

www.fda.gov). Treatment technology 

and equipment that have been modified 

to the point where operating parameters 

such as time, temperature, or volume, 

change must be revalidated. 

For purposes of this document, a 

process authority is a person that has 

expert knowledge of appropriate 

processes for the treatment of almonds 

as described above, and meets other 

criteria as specified by the Board. Such 

criteria include the following: (1) 

Knowledge about the equipment used 

for the treatment process; (2) experience 

in conducting appropriate studies to 

determine the ability of the equipment 

to deliver the appropriate treatment 

(such as heat penetration or heat 

distribution studies); and (3) the ability 

to determine that sufficient data has 

been gathered to identify the critical 

factors needed to ensure the quality of 

the final product. Process authorities 

must submit an application to the Board 

on ABC Form No. 51, ‘‘Application for 

Process Authority for Almonds,’’ and be 

approved by the TERP. Should the 

applicant disagree with the TERP’s 

decision concerning approval, it may 

appeal the decision in writing to the 

Board, and ultimately to USDA. 

Additionally, the TERP may revoke any 

approval for cause. The TERP must 

notify the process authority in writing of 

the reasons for revoking the approval. If 

the process authority disagrees with the 

TERP’s decision, he/she may appeal the 

decision in writing to the Board, and 

ultimately to USDA. A process authority 

whose approval has been revoked must 

submit a new application to the TERP 

and await approval. 

As explained later in this document, 

process authorities may also ‘‘establish’’

treatment processes for manufacturers 

under the DV program. The procedures 

and criteria for process authorities who 

establish treatment processes are 

identical to those for process authorities 

who validate such processes. 

‘‘Establish’’ means that the treatment 

processes and protocols have been 

evaluated to ensure the technology’s 

ability to deliver a lethal treatment for 

Salmonella in almonds to achieve a 

minimum 4-log reduction. 

Compliance and Verification Program 

Treatment Plans 

To ensure compliance with the 

mandatory program, handlers will be 

subject to verification by the Federal or 

Federal-State Inspection Service 

(inspection agency) and review by 

Board staff. Handlers may use either an 

on-site (traditional) or an audit-based 

verification program. Each handler must 

decide which verification program will 

be the most cost-effective for his or her 

operation. All handlers must submit a 

treatment plan to the Board for the 

upcoming crop year by May 31. The 

crop year runs from August 1 through 

July 31 of the subsequent year. The plan 

will be reviewed by the Board in 

conjunction with the inspection agency 

to ensure such plans are complete and 

auditable. The plan will be approved by 

the Board and must address specific 

parameters for the handler to ship 

almonds. Such parameters include, but 

are not limited to, the following: (1) The 

location of treatment plant; (2) the name 

and address of off-site treatment facility 

(custom processor), if appropriate; (3) a 

statement regarding whether treatment 

processes have been accepted by the 


cprice-sewell on PROD1PC66 with RULES
15024 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

TERP and/or ‘‘determined’’ by the FDA; 

(4) a statement regarding validation of 

treatment technology and equipment by 

a Board-approved process authority; (5) 

a statement whether untreated almonds 

will be exported; (6) a statement 

whether the handler will use the DV 

program; (7) a description or flow chart 

explaining how raw, untreated almonds 

enter and flow through the handler 

facility, and how the product would 

flow through the treatment process, 

including post treatment, packing, and/ 

or storage; (8) a list of all treatments that 

will be used on the almonds (including, 

for example, number of blanching lines, 

etc.); (9) a description of how treated 

product will be differentiated and 

segregated from untreated product to 

ensure maintenance of treated product 

integrity; (10) a list of procedures 

regarding how interhandler transfers 

will be tracked; and (11) an explanation 

by handlers using a combination of 

processes to achieve a minimum 4-log 

reduction, that the processes occur in an 

appropriate sequence in sufficiently 

close proximity to ensure that the 

integrity of the treated product is 

maintained between processes. 

Almonds sent by a handler for 

treatment to an off-site facility affiliated 

with another handler will be subject to 

the approved treatment plan utilized at 

that off-site facility. Handlers must 

follow their own approved treatment 

plans for almonds sent to an off-site 

facility that is not affiliated with another 

handler. 

Additionally, an off-site treatment 

facility that does not handle almonds, 

pursuant to § 981.16, must provide 

access to the inspection agency and 

Board staff for verification of treatment 

and review of treatment records. A 

treatment process at an off-site facility 

that has been validated by a Boardapproved process authority is deemed to 

be approved by the Board for handler 

use. The Board may revoke any such 

approval for cause. The Board must 

notify the off-site treatment facility of 

the reasons for revoking the approval. 

Should the off-site facility disagree with 

the Board’s decision, it may appeal the 

decision in writing to USDA. Handlers 

may treat their almonds only at off-site 

treatment facilities that have been 

deemed to be approved by the Board. 

On-Site Verification Program 

Under an on-site verification program, 

handlers must cause the inspection 

agency to verify that their almonds were 

subjected to a treatment process that 

was validated by a Board-approved 

process authority. Such handlers must 

submit, or cause to be submitted, a 

verification report to the Board. The 

inspection agency must physically 

observe the treatment process to issue 

such a report. It is the handler’s 

responsibility to arrange for inspection 

agency verification. An on-site program 

is comparable to a traditional in-line or 

lot inspection program. 

Audit-Based Verification Program 

Under an audit-based verification 

program, handlers will be subject to 

periodic audits conducted by the 

inspection agency. The inspection 

agency will verify that handlers were 

following the treatment parameters and 

protocols specified in their approved 

treatment plans. Audit frequency will be 

tied to handler performance. Handlers 

will be provided with written audit 

reports specifying deficiencies. 

Handlers who do not comply with an 

audit-based verification program will be 

required to revert to an on-site 

verification program. Audit reports will 

be provided to the Board to facilitate 

program compliance. 

Interhandler Transfers 

Interhandler transfers of almonds may 

or may not be treated prior to transfer. 

Handlers receiving untreated almonds 

from another handler will be 

responsible for treating the product. 

Handlers receiving treated almonds 

from another handler must have 

procedures outlined in their treatment 

plan addressing how the integrity of the 

treated almonds will be maintained. In 

all instances involving interhandler 

transfers, it will be the responsibility of 

the receiving handler to ensure that the 

almonds are treated prior to shipment 

and to maintain documentation to that 

effect. As provided in § 981.455, 

handlers must submit an ABC Form No. 

7, ‘‘Interhandler Transfer of Almonds,’’

to the Board when they are involved in 

interhandler transfers. 

Records 

Handlers will be required to maintain 

records and documentation that will be 

subject to audit by the inspection 

agency and the Board for the purpose of 

verifying compliance with the 

regulation. Consistent with § 981.70 of 

the order regarding handler records and 

verification, records must be maintained 

for 2 full years following the end of a 

crop year. Such records must identify 

lots from the point of treatment forward 

to the point of shipment by the handler. 

Lot identification must also provide the 

ability to differentiate treated from 

untreated product. Additionally, off-site 

treatment facilities located within the 

production area that provide the service 

of treating almonds for handlers, but are 

not handlers themselves, must maintain 

treatment records for 2 full years 

following the end of a crop year and 

make such records available to the 

Board. 

Exemptions 

Direct Verifiable Program 

Handlers may ship untreated almonds 

directly to Board-approved 

manufacturers (DV users) within the 

U.S., Canada, or Mexico for further 

processing under the Direct Verifiable or 

DV program. The Board will issue a DV 

user code to an approved manufacturer. 

Handlers must reference this code on all 

documentation accompanying the lot. 

This will help the Board track DV 

shipments and facilitate compliance 

with the program. Handlers must also 

identify each container of such almonds 

with the term ‘‘unpasteurized.’’

Container means a box, bin, bag, carton, 

or any other type of receptacle used in 

the packaging or handling of bulk 

almonds. The lettering must be on one 

outside principal display panel, at least 

1⁄2 inch in height, clear and legible. If a 

third party is involved in the 

transaction, the handler must provide 

sufficient documentation to the Board to 

track the shipment from the handler’s 

facility directly to the approved DV 

user. While a third party may be 

involved in such transactions, 

shipments to a third party and then to 

a manufacturing location are not 

permitted under the DV program. 

Almonds under the DV program must be 

shipped directly from handlers to 

approved manufacturing locations. 

Manufacturers wanting to participate 

in the DV program must submit an 

application to the Board on ABC Form 

No. 52, ‘‘Application for Direct 

Verifiable (DV) Program for Further 

Processing of Untreated Almonds,’’ and 

be approved by the TERP. Should the 

applicant disagree with the TERP’s 

decision concerning approval, it may 

appeal the decision in writing to the 

Board, and ultimately to USDA. 

Additionally, the TERP may revoke any 

approval for cause. The TERP must 

notify the manufacturer in writing of the 

reasons for revoking the approval. If the 

manufacturer disagrees with the TERP’s 

decision, it may appeal the decision in 

writing to the Board, and ultimately to 

USDA. A manufacturer whose approval 

has been revoked must submit a new 

application to the TERP and await 

approval. 

Similar to handlers, manufacturers 

must subject the almonds to a treatment 

process or processes using technologies 

that achieve in total a minimum 4-log 

reduction of Salmonella bacteria as 

determined by the FDA or accepted by 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15025 

the TERP. Additionally, manufacturers 

may use treatment processes that have 

been ‘‘established’’ by a Board-approved 

process authority. As previously stated, 

‘‘established’’ means that the process 

authority has evaluated the treatment 

processes and protocols to ensure the 

technology’s ability to deliver a lethal 

treatment for Salmonella in almonds to 

achieve a minimum 4-log reduction. 

The Board recommended this option to 

address manufacturers’ concern 

regarding the process to seek TERP 

acceptance of their treatments, which 

could involve providing data on their 

proprietary processes to the TERP (i.e., 

specific time and temperature data for 

special equipment). DV users must 

submit with their application to the 

TERP documentation to verify that their 

treatment technology and equipment 

have been validated by a Boardapproved process authority. Such 

documentation may include, but not be 

limited to, a letter from a process 

authority certifying the validation. The 

documentation must be sufficient to 

demonstrate that the treatment 

processes and equipment achieve a 4- 

log reduction in Salmonella bacteria. 

Manufacturers must also do the 

following: (1) Identify the 

manufacturing locations where 

treatment will occur; (2) have their 

treatment technology and equipment 

validated by a Board-approved process 

authority. Treatment technology and 

equipment that have been modified to 

the point where operating parameters 

such as time, temperature, or volume, 

change must be revalidated; (3) 

maintain all records regarding 

validation and verification of treatment 

methods, processing, and product 

traceability for 2 years, and make such 

records available for review by the 

Board; and (4) ship untreated almonds 

(due, for example, to a manufacturer 

overbuying) to a handler, to another 

approved DV user, to locations outside 

the U.S., Canada, or Mexico (containers 

must remain identified with the term 

unpasteurized), or dispose of such 

almonds in non-edible channels. 

Further, DV users will be audited by 

a Board-approved auditor within 1–2 

months after the start of treatments, and 

at least once every 12 months thereafter. 

The cost of the DV audit shall be borne 

by the manufacturer. Such audits will 

determine if: (1) The DV user utilized 

appropriate treatment processes; (2) the 

DV user has a letter issued by a Boardapproved process authority that 

validated that the treatment achieves a 

4-log reduction of Salmonella; (3) 

personnel and procedures used at the 

facility ensure that treatment parameters 

were followed; and (4) records are 

retained for two years that document the 

treatment of almonds, or that any 

untreated almonds were properly 

disposed of as outlined above. A 

summary audit report of the DV user 

will be sent to the Board within 10 days 

of the audit. DV user auditors must 

submit an application to the Board on 

ABC Form No. 53, ‘‘Application for 

Direct Verifiable (DV) Program 

Auditors,’’ and be approved by the 

TERP. Should the applicant disagree 

with the TERP’s decision concerning 

approval, it may appeal the decision in 

writing to the Board, and ultimately to 

USDA. Additionally, the TERP may 

revoke any approval for cause. The 

TERP must notify the DV auditor in 

writing of the reasons for revoking the 

approval. If the DV auditor disagrees 

with the TERP’s decision, it may appeal 

the decision in writing to the Board, and 

ultimately to USDA. A DV auditor 

whose approval has been revoked must 

submit a new application to the TERP 

and await approval. 

The Board recommended including 

Mexico and Canada as part of the DV 

program for compliance purposes. The 

Board was concerned that handlers 

could circumvent the regulation by 

shipping untreated almonds to Mexico 

or Canada, then, bring them back into 

the U.S. and sell them in normal market 

channels. 

Shipments Outside of the U.S., Canada, 

or Mexico 

Handlers may also ship untreated 

almonds directly to locations outside 

the U.S., Canada, or Mexico, provided 

that each container of such almonds is 

prominently identified with the term 

unpasteurized. The lettering must be on 

one outside principal display panel, at 

least 1⁄2 inch in height, clear and legible. 

Again, if a third party is involved in the 

transaction, the handler must provide 

sufficient documentation to the Board to 

track the shipment from the handler’s 

facility directly to the importer in the 

foreign country. 

Accordingly, a new paragraph (b) 

regarding outgoing quality control and a 

mandatory program to reduce the 

potential for Salmonella bacteria 

contamination in almonds is added to 

§ 981.442 of the order’s administrative 

rules and regulations. 

Final Regulatory Flexibility Analysis 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA), the 

Agricultural Marketing Service (AMS) 

has considered the economic impact of 

this rule on small entities. Accordingly, 

AMS has prepared this final regulatory 

flexibility analysis. Comments 

concerning the impact of the rule on 

small entities are discussed in the 

Analysis of Comments section below. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

business subject to such actions in order 

that small businesses will not be unduly 

or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and the rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. Thus, both statutes have small 

entity orientation and compatibility. 

There are approximately 6,000 

producers of almonds in the production 

area and approximately 115 handlers 

subject to regulation under the 

marketing order. Additionally, the 

Board estimates there will be about 25 

process authorities, 53 almond 

manufacturers, 50 DV program auditors, 

and 20 off-site California treatment 

facilities (non-handlers) impacted by 

this rule. Small agricultural producers 

are defined by the Small Business 

Administration (13 CFR 121.201) as 

those having annual receipts of less than 

$750,000, and small agricultural service 

firms are defined as those whose annual 

receipts are less than $6,500,000. 

Data for the most recently completed 

crop year indicate that about 52 percent 

of the handlers shipped under 

$6,500,000 worth of almonds. Dividing 

average almond crop value for 2003–

2005 reported by the National 

Agricultural Statistics Service (NASS) 

($2.043 billion) by the number of 

producers (6,000) yields an average 

annual producer revenue estimate of 

about $340,000. Based on the foregoing, 

about half of the handlers and a majority 

of almond producers may be classified 

as small entities. While data regarding 

the size of process authorities, almond 

manufacturers, DV program auditors, 

and off-site treatment facilities (nonhandlers) is not available, it may be 

assumed that some process authorities, 

almond manufacturers, DV program 

auditors, and off-site California 

treatment facilities (non-handlers) may 

be classified as small entities. 

The almond industry’s 6,000 growers 

produce approximately 1 billion pounds 

annually (kernel weight basis). Industry 

members expect production to increase 

by 50 percent in the next 3–5 years, due 

to a significant amount of newly planted 

acreage that will come into production. 

Although the Board currently projects 

that that there are about 115 handlers, 

handler number estimates can vary over 

time. Recent surveys have yielded 

estimates ranging from 112 (see Table 1) 

to 117 (see Table 2). Handlers ultimately 

market their almonds to customers in 

the U.S. and abroad. As shown in Table 


cprice-sewell on PROD1PC66 with RULES
15026 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

1, the Board estimates that about 27 of 

112 handlers handle more than 10 

million pounds each, and cumulatively 

handle 82 percent of the crop. 

TABLE 1.—NUMBER OF HANDLERS CATEGORIZED BY SIZE

Less than 1 

million lbs. 

Between 1 

and 5 million 

lbs. 

Between 5 

and 10 million 

lbs. 

More than 10 

million lbs. 

No. of handlers ................................................................................................ 41 28 16 27 

Percent of crop handled .................................................................................. 1 6 11 82 

According to data provided by the 

Board, about 30 percent of California 

almonds are sold domestically (about 

300 million pounds). An estimated 20 

percent of the domestic shipments are 

in the form of manufactured product—

blanched, sliced, diced, or otherwise 

further processed using thermal 

treatments. About 70 percent of 

California almond production is 

exported to more than 80 countries 

worldwide. Mexico and Canada account 

for approximately 5 percent of export 

shipments. The quantities shipped by 

companies handling almonds vary 

considerably. However, a limited 

number of handlers are responsible for 

the majority of domestic and export 

shipments as shown in Table 2 below. 

Table 2 shows that 16 handlers are 

responsible for 90 percent of domestic 

shipments. Many of the same handlers 

are among the 38 that are responsible for 

90 percent of exports. About 79 of an 

estimated 117 handlers are responsible 

for the remaining 10 percent of export 

shipments. 

TABLE 2.—HANDLER SHIPMENT SUMMARY

Domestic 

(U.S.) 

300,000,000 

pounds 

Export to 

Canada and 

Mexico 

37,600,000 

pounds 

All export 

(includes Canada and Mexico) 

700,000,000 

pounds 

No. of handlers responsible for 50 percent of shipments ........................................................... 3 4 9 

No. of handlers responsible for 80 percent of shipments ........................................................... 12 16 26 

No. of handlers responsible for 90 percent of shipments ........................................................... 16 26 38 

This rule adds a new paragraph (b) for 

outgoing quality control under § 981.442 

of the order’s administrative rules and 

regulations, whereby a mandatory 

program to reduce the potential for 

Salmonella bacteria in almonds will be 

implemented under the order. 

Specifically, handlers must subject their 

almonds to a treatment process that 

achieves a minimum 4-log reduction in 

Salmonella bacteria prior to shipment. 

The program exempts handlers who 

ship untreated almonds under a direct 

verifiable (DV) program to 

manufacturers within the U.S., Canada, 

or Mexico who agree to treat the 

almonds accordingly. The program also 

exempts handlers who ship untreated 

almonds to locations outside of the U.S., 

Canada, or Mexico. All containers of 

untreated almonds shipped under the 

exemptions must be prominently 

identified with the term 

‘‘unpasteurized.’’ Authority for the 

program is provided in § 981.42(b) of 

the order. 

According to the Board, the costs to 

individual handlers to comply with the 

program will vary considerably 

depending on their markets and 

treatment method(s) chosen. Handlers 

may: (1) Install new equipment in their 

processing lines to treat the almonds 

prior to shipment into commercial 

channels; (2) outsource to another 

handler or an off-site facility within 

California for treatment; (3) transfer 

their untreated product to another 

handler who will treat the almonds 

prior to shipment; (4) ship their 

untreated almonds to Board-approved 

DV users or to locations outside of the 

U.S., Canada, or Mexico; or (5) use a 

combination of these approaches. 

In a handler survey conducted by the 

Board in March 2005 (to which 116 

handlers handling almonds at that time 

responded), 86 handlers (74 percent) 

have their own facilities and/or 

equipment to process almonds; the 

remainder have almonds processed on 

their behalf. Of those handlers with 

their own facilities and/or equipment, 

66 (77 percent of 86) indicated they 

planned to install equipment to treat 

almonds while the remaining 20 

indicated they would outsource to a 

third party, or custom processor. Again, 

the overall economic impact of the 

program will vary based on the 

approach selected. Smaller handlers 

may choose to defer purchasing 

equipment and send their almonds to an 

off-site facility for treatment until more 

cost effective technologies are available. 

Costs will also vary by treatment 

method. Some handlers may choose to 

install PPO chambers at their facilities. 

Handler sources estimate that typical 

installation costs for a PPO chamber 

range from $500,000 to $1,250,000. As 

with other technologies, overall cost 

will depend upon how much 

infrastructure is in place in the 

processing facility as well as the desired 

capacity of the chambers. Actual 

treatment cost for handlers treating their 

own product is approximately $0.03 per 

pound, varying with volume and 

efficiencies. PPO treatment is currently 

available in the industry on a contract 

basis at $0.04–$0.05 per pound 

(including transportation to the facility). 

Regarding steam technologies, 

handler sources estimate the following 

equipment costs for in-line steam 

systems designed to treat almonds at 

varying capacities from 1,000 pounds to 

over 30,000 pounds of almonds per 

hour: 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15027 

TABLE 3.—ESTIMATED EQUIPMENT

COSTS FOR STEAM UNITS FOR DIFFERING LEVELS OF TREATMENT CAPACITY

Capacity 

(pounds per hour) Equipment costs 

1,000 ......................... $100,000–$200,000 

5,000 ......................... 300,000–325,000 

7,500–15,000 ............ 370,000–470,000 

20,000–30,000 .......... 525,000–800,000 

Over 30,000 .............. 600,000–1,000,000 

While treatment equipment costs will 

be the most significant outlay, there will 

also be capital expenditures associated 

with additional conveyance equipment, 

boilers, cooling systems, bins, and 

possible expansion or construction of 

new buildings. Handler sources estimate 

these costs to be an additional 50 

percent of the treatment equipment 

costs cited in Table 3, depending on 

capacity needs, and assuming maximum 

throughput. 

A typical system of 10 million pound 

annual capacity will be equivalent to 

22,000 pounds per hour, which falls in 

the 20,000 to 30,000 pound per hour 

range in Table 3. The treatment 

equipment costs for that capacity range 

from $525,000 to $800,000. With an 

additional 50 percent for cost of other 

related equipment and facility 

expansion, the costs range from 

$787,500 to $1,200,000. Handler sources 

suggest that a figure near the upper end 

of that range, $1,125,000, is a good point 

estimate of the cost for a 10,000,000 

pound per year treatment line. 

An important step in assessing the 

financial impact of the mandatory 

treatment program on handlers is to 

estimate the annualized equipment cost 

and operating cost of treating the 

almonds to prevent Salmonella 

contamination. This can be illustrated 

by additional computations, with 

10,000,000 pounds per year serving as a 

representative level of treatment 

capacity, as shown in Table 4, third line 

of column A. Table 4 also shows a range 

of costs across different levels of 

handler treatment capacity. 

TABLE 4.—ESTIMATE OF AVERAGE ANNUAL EQUIPMENT AND OPERATING COSTS AT VARYING LEVELS OF HANDLER

TREATMENT CAPACITY

A 

Handler annual capacity 

(Pounds) 

B 

Total equipment cost* 

C 

Annual use 

cost of equipment, 5 year 

life** 

D E 

Unit Cost of Equipment at: 

F 

Average operating cost 

G H 

Equipment plus operating 

cost at: 

50% of 

capacity 

(C/50% of A) 

Full capacity 

(C/A) 

50% of 

capacity 

(D + F) 

Full capacity 

(E + F) 

Cents per pound 

2,000,000 ..................... $300,000 $69,292 $0.069 $0.035 $0.0035 $0.0725 $0.0385 

5,000,000 ..................... 487,500 112,600 0.045 0.023 0.0035 0.0485 0.0265 

10,000,000 ................... 1,125,000 259,845 0.052 0.026 0.0035 0.0555 0.0295 

15,000,000 ................... 1,500,000 346,460 0.046 0.023 0.0035 0.0495 0.0265 

20,000,000 ................... 1,650,000 381,106 0.038 0.019 0.0035 0.0415 0.0225 

* Equipment cost estimates at varying capacity levels, including treatment chambers, plus an additional 50 percent for conveyors, other equipment and extension of facilities. 

** Annualized equipment cost is computed by dividing the equipment purchase cost by 4.3295, which is the Present Value of a $1 annuity for 

5 Years (estimated life of the equipment) at a 5 percent interest rate (estimated cost of capital). 

Source for equipment and operating costs: Almond handlers. 

To obtain the annual unit cost for 

installing a 10 million pound capacity 

treatment line (an expenditure of 

$1,125,000 in column B), the first step 

is to obtain the annualized equipment 

cost. The parameters recommended by 

the handlers were a 5 year equipment 

life and a 5 percent cost of capital. The 

annual equipment use factor (4.3295) is 

the present value of a $1 annuity for 5 

years at 5 percent. Dividing the total 

equipment expenditure of $1,125,000 by 

4.3295 yields an annualized equipment 

cost estimate of $259,845 (column C). 

Dividing this figure by the annual 

10,000,000 pound capacity yields a cost 

per pound estimate of 2.6 cents (column 

E). If the treatment line ran at half 

capacity, the equipment costs per pound 

would double to 5.2 cents (column D). 

This method of computing annualized 

equipment cost does not account for the 

tax implications of annual equipment 

depreciation or for the salvage value at 

the end of the equipment’s useful life. 

In addition, the useful life of many 

pieces of equipment may well be over 

5 years. 

Ongoing operational costs (electricity, 

etc.) are estimated by handlers to range 

from $0.0027 to $0.0043 per pound, 

depending on the system. The midpoint 

of this range ($0.0035) appears in 

column F. 

The key results from Table 4 are the 

cost estimates per pound of almonds 

treated, including both annualized 

equipment costs and operating costs. 

The highest cost is 7.25 cents per pound 

for the smallest handler (2 million 

pounds treated annually) operating at 50 

percent capacity (column G). The lowest 

cost estimate is 2.25 cents per pound for 

a handler treating 20 million pounds per 

year operating at full capacity (column 

H). These costs can be put in context by 

comparing them to almond grower 

prices as reported each year by the 

NASS. For 2003 to 2005, grower prices 

averaged $2.07 per pound, computed by 

dividing the value of production for 

those three years by the three-year 

quantity of production. The treatment 

cost estimates per pound in Table 4 

range from 3 percent to 1 percent of the 

2003–2005 average grower price, and 

represent an even smaller proportion of 

the prices paid to handlers when selling 

to almond users further down the 

marketing chain. 

A key aspect of handler costs is the 

proportion of total capacity at which a 

new production line will operate. 

Operating at higher capacity spreads the 

equipment cost across a wider base. For 

a small handler, investing in equipment 

with this level of capacity may only be 

viable economically if the costs are 

spread over their entire production run, 

rather than only applying costs to a 

small portion of their production run. If 

they do not intend to run their entire 

production through the treatment 

process, it may be more viable to 

outsource the treatment. Costs of 

contract processing (i.e., batch 

operations for steam processes or PPO 

treatment) are estimated to range from 

$0.04 to $0.05 per pound. This estimate 

includes additional costs associated 


cprice-sewell on PROD1PC66 with RULES
15028 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

with transporting almonds to a custom 

facility ($0.01 to $0.015 per pound). For 

medium-sized and larger handlers, it 

may be more cost effective to construct 

a treatment processing line, particularly 

if they intend to immediately put a 

significant portion of their production 

through the process. 

Handler sources estimate that the cost 

of setting up a new oil roast line is 

$300,000 to $600,000, with operating 

costs of $0.06 to $0.10 per pound. A 

blanching line may cost upward of 

$1,500,000 to $2,500,000 with an 

operating cost of approximately $0.12 to 

$0.22 per pound. It is unlikely that 

handlers will select these technologies 

unless they are already providing 

custom processed, value-added 

products to their customers. 

Regarding compliance and oversight 

costs, it is anticipated that handlers who 

do not currently have thorough 

recordkeeping procedures in place will 

likely have to invest approximately 40–

80 person-hours to develop their 

treatment plan. However, once this 

document has been created, it will be 

updated on an annual basis, which will 

likely involve less time. Validation of 

treatment systems is estimated to cost 

from $1,000 to $3,000 per line, 

depending upon the complexity of the 

equipment utilized. Treatment 

technology and equipment that have 

been modified to the point where 

operating parameters such as time, 

temperature, or volume, change must be 

revalidated. Validation costs are 

expected to be borne by handlers, as 

well as DV users and off-site treatment 

facilities (non-handler). DV audit costs 

will be borne by DV users. 

Handler verification costs may vary, 

depending on whether the handler is 

under an on-site program or an auditbased program. The fee for an on-site 

program will be a minimum charge of 

$44.00 per hour (with 1 hour required 

to treat 44,000 pounds), or $0.204 per 

hundredweight, whichever is greater. 

The former is equivalent to $1.00 per 

thousand pounds treated. For an auditbased program, the fee will be a 

minimum $78.00 per hour. Travel time 

for both programs will be charged at 

$44.00 per hour and $0.34 per mile. 

Verification costs may also be charged 

to off-site treatment facilities (nonhandler); however, such costs may be 

passed on to the respective handlers 

using the facility. 

Examples of estimated handler 

verification costs are provided in Tables 

5 and 6 below: 

TABLE 5.—ANNUAL HANDLER VERIFICATION COSTS: ON-SITE PROGRAM

Audit cost by type 

Volume of almonds treated per year 

100,000 lbs. 2 mill. lbs. 40 mill. lbs. 100 mill. lbs. 250 mill. lbs. 

Hourly rate* .......................................................................... $100 $2,000 $40,000 $100,000 $250,000 

Per Cwt=$.204 ..................................................................... 204 4,080 81,600 204,000 510,000 

*Hourly rate of $44/hour, with 1 hour required per 44,000 lbs of volume treated (equivalent to $1.00 per thousand pounds treated). 

TABLE 6.—ANNUAL HANDLER VERIFICATION COSTS: AUDIT-BASED PROGRAM

Audit cost by hours required to complete audit* 

1 2 3 4 5 6 7 8 

Audit hourly cost=$78 ...... $78 $156 $234 $312 $390 $468 $546 $624 

Auditor Transportation 

Cost ** ........................... 32 32 32 32 32 32 32 32 

Cost per individual audit .. 110 188 266 344 422 500 578 656 

*Estimated hours per audit varies by volume treated annually: (up to 2 million pounds: 1–3 hours); (more than 2 but less than 40 million 

pounds: 2–5 hours); (40 million pounds or more: 3–8 hours). 

**Estimated auditor transportation cost to each facility is approximately $32: $22 for travel time (1/2 hour @ $44/hour) plus mileage reimbursement of $10 (30 miles @ $0.34 per mile). 

The benefits associated with the 

mandatory program are the avoided 

costs of a Salmonella outbreak. These 

costs may vary depending on several 

factors, including the quantity of 

product recalled, impact on consumer 

sales, lost customer confidence, 

insurance costs, and possible litigation. 

Using 2003–2005 average almond crop 

value as the basis, a loss of 5 percent 

would be equal to approximately $102 

million. 

The Board considered various 

alternatives and options to a mandatory 

treatment program. One option was to 

take no action. However, the Board 

concluded that this was not in the best 

interest of the industry nor consumers. 

The Board believes that the industry 

should provide consumers with a 

quality product. Taking no action when 

there are viable alternatives could be 

significant in terms of the financial well 

being of the industry should another 

outbreak occur that was linked to 

almonds. 

The Board also considered continuing 

its voluntary action plan alone, without 

proposing a mandatory program. 

However, surveys conducted by the 

Board indicate that not all handlers are 

implementing the action plan. Thus, the 

Board concluded that a mandatory 

program is in the best interest of the 

industry and consumers. 

The Board also considered the 

effectiveness of testing for Salmonella 

prior to shipment. During the 2001 and 

2004 outbreaks, significant amounts of 

testing occurred at the orchard level, in 

hulling and shelling facilities, and at 

retail. However, it was determined by 

the CDHS, University of California, 

Davis, and other pathogen experts that 

testing cannot be relied upon as the only 

measure to ensure that almonds are 

Salmonella free. Thus, the Board 

concluded that testing alone was not a 

viable alternative. 

The Board also explored the merits of 

requiring alternative log reductions. As 

previously mentioned, the Board 

initially supported a 5-log reduction, 

which was FDA’s performance standard. 

However, a risk assessment model 

demonstrated that a minimum 4-log 

reduction could provide an appropriate 

level of consumer protection compared 

to a 5-log reduction. Thus, the Board 

concluded that a minimum 4-log 

reduction was an appropriate standard 

for almonds. 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15029 

The Board also explored the merits of 

whether the DV program should be 

temporary, whereby all almonds would 

be treated at the handler level prior to 

shipment. The Board submitted an 

initial proposal to USDA in February 

2006 that would have ultimately 

required handlers to treat all almonds 

prior to shipment, with the DV program 

being temporary. However, concerns 

were raised by various parties, 

including manufacturers, handlers, and 

foreign countries, regarding the 

temporary nature of the DV program, 

and the requirement that all exported 

almonds be treated prior to shipment. 

The Board ultimately revised its 

proposal to remove the proviso 

regarding discontinuance of the DV 

program, to allow untreated almonds to 

be shipped to locations outside the U.S., 

Canada, or Mexico, and to require that 

all containers of untreated almonds be 

prominently identified with the term 

‘‘unpasteurized.’’

This action imposes additional 

reporting and recordkeeping burden on 

California almond handlers, process 

authorities, almond manufacturers, DV 

program auditors, and off-site treatment 

facilities. Process authorities, 

manufacturers, and DV auditors must 

submit respective applications to the 

Board. Almond handlers must submit 

treatment plans to the Board. In 

accordance with the Paperwork 

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

Chapter 35), these new forms and a 

sample ‘‘Handler Treatment Plan’’ were 

submitted to the Office of Management 

and Budget (OMB) and have been 

approved under OMB Control No. 0581–

0242, Almonds Grown in California. 

Specific burdens for the three new 

applications and handler treatment plan 

are addressed in the section below titled 

Paperwork Reduction Act. ABC Form 

No. 7, ‘‘Interhandler Transfer of 

Almonds,’’ has previously been 

approved by OMB under OMB Control 

No. 0581–0178, ‘‘Vegetable and 

Specialty Crop Marketing Orders. As 

with all Federal marketing order 

programs, reports and forms are 

periodically reviewed to reduce 

information requirements and 

duplication by industry and public 

sector agencies. Finally, USDA has not 

identified any relevant Federal rules 

that duplicate, overlap, or conflict with 

this rule. 

The AMS is committed to complying 

with the E-Government Act, to promote 

the use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

Additionally, the meetings were 

widely publicized throughout the 

California almond industry and all 

interested persons were invited to 

attend the meetings and participate in 

deliberations on all issues. Between the 

summer of 2004 and the Board’s August 

2006, meeting, this issue was addressed 

at an estimated 12 Board meetings, 18 

Food Quality and Safety Committee 

meetings, and well over 20 task force 

meetings. All of these meetings were 

public meetings and all entities, both 

large and small, were able to express 

views on this issue. Additionally, the 

Board issued about 35 updates to 

handlers regarding its voluntary action 

plan and progress towards its 

recommended mandatory program. 

Analysis of Comments 

A proposed rule concerning this 

action was published in the Federal 

Register on December 6, 2006 (71 FR 

70683). Copies of the rule were also 

mailed or sent via facsimile to all 

almond handlers. Finally, the proposal 

was made available through the Internet 

by USDA and the Office of the Federal 

Register. A 45-day comment period 

ending January 22, 2007, was provided 

for interested persons to respond to the 

proposal. Eighteen comments were 

received. Of the 18 comments, 3 

supported the rule with no changes, 7 

supported the rule with modification, 3 

were opposed, and the remaining 5 

comments raised other issues. The 

comments are addressed in the 

following paragraphs. 

Comments in Full Support 

The three comments which supported 

the rule with no changes were 

submitted by a grower cooperative/ 

handler/marketer; a grower/handler; 

and a trade association representing 

almond hullers and shellers. One 

commenter believes the rule is 

necessary to prevent Salmonella from 

reaching the consuming public via 

California almonds. Another of the 

commenters summarized his company’s 

experience in a Salmonella outbreak 

and recall. He contends that, based on 

his company’s experience with 

treatments, there has been no noticeable 

impact on product shelf-life, roasting, or 

flavor to consumers. He added that his 

raw almond business has increased 

since implementing 100 percent 

treatment with no increase in quality 

complaints. The third commenter 

believes that the livelihood of the 

industry is at risk if it does not proceed 

immediately to mitigate the presence of 

Salmonella in its product. All of the 

commenters supported implementation 

of the rule as soon as possible. 

Comments in Support, With 

Modification 

The seven comments which 

supported the rule with modification 

were submitted by the Board; a trade 

association representing food, beverage, 

and consumer product companies; a 

trade association representing 

confectionary manufacturers, suppliers, 

buyers, and brokers; a chocolate and 

confectionary manufacturer; a 

processor/marketer of nut products; a 

handler; and a grower/handler. 

Four of the commenters addressed the 

proposed reporting requirements. Three 

of these comments expressed concern 

with an annual submission of an 

application for DV users. Two suggested 

that, once the DV user has been 

approved by the Board and is on an 

approved list, there is no reason to 

remove the entity except for cause, or at 

the request of the DV user. Another 

suggested that, if a DV user does not 

change its treatment technology, and if 

a problem has not been identified by the 

DV auditor, there is no reason for DV 

users to reapply annually to the Board. 

Two commenters suggested that the 

initial approval for process authorities 

and DV auditors should be sufficient, 

adding that agency approval is not 

required under regulations governing 

production of low-acid canned foods, 

which is the source of the process 

authority concept. 

The Board commented that the DV 

user and auditor applications were 

designed so that once the entity is 

originally approved, it would only have 

to reconfirm participation in subsequent 

years. A new or modified application 

would only be necessary in cases where 

new procedures, equipment, or 

processing locations have been 

introduced. 

Based on the comments received, 

USDA has determined that 

modifications to the proposed rule 

regarding reporting requirements are 

warranted. Process authorities, DV 

users, and DV auditors must submit an 

initial application to the Board. For 

subsequent crop years, such approved 

entities with changes in the information 

contained in their initial application 

must submit a new, revised application 

to the Board for review and approval 

prior to the start of the crop year. 

Approved applicants with no changes to 

their initial application must send the 

Board a letter, signed and dated, 

indicating that there are no changes to 

the application the Board has on file. In 

the new § 981.442(b)(3) regarding the 

application for process authorities, 

§ 981.442(b)(6)(i) regarding the 

application for DV users, and 


cprice-sewell on PROD1PC66 with RULES
15030 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

§ 981.442(b)(6)(i)(D) regarding the 

application for DV auditors are revised 

accordingly. The revised reporting 

burdens are addressed in the section 

below titled Paperwork Reduction Act. 

Three of the comments raised various 

issues regarding process authorities. 

One issue concerned the release of 

proprietary information regarding 

manufacturers’ processes. Two 

commenters suggested adding language 

to the regulatory text that clarifies, as 

the preamble does, the role of process 

authorities in establishing technologies 

for manufacturers, in particular, the 

protection this option provides 

regarding proprietary data under the DV 

program. The commenters want to 

ensure that disclosure of data on 

manufacturers’ proprietary processes is 

not required for determination of 

acceptance by the TERP of 

manufacturers’ treatment processes. The 

Board commented that process 

authorities for DV users must provide 

reports to the Board that contain 

sufficient content to describe the 

verification methodologies that were 

used to establish that the treatment 

processes and technologies achieve a 

minimum 4-log reduction in Salmonella 

bacteria. The Board contends that the 

TERP would not require information 

regarding manufacturers’ proprietary 

manufacturing processes. 

As previously stated, manufacturers’

use of treatment processes established 

by process authorities was included in 

the regulation to address concerns 

regarding the release of data on 

manufacturers’ proprietary processes to 

the TERP. Modification of the regulatory 

text to address this is not warranted. 

However, USDA concurs that the Board 

needs documentation to ensure that 

processes established by process 

authorities achieve a 4-log reduction in 

Salmonella bacteria. Accordingly, 

§ 981.442(b)(6)(i)(C) is revised to specify 

that DV users must provide 

documentation with their DV 

application to the TERP to verify that 

their treatment technology and 

equipment have been validated by a 

Board-approved process authority. Such 

documentation may include, but not be 

limited to, a letter from such process 

authority certifying the validation. 

Finally, such documentation must be 

sufficient to demonstrate that the 

treatment processes and equipment 

achieve a 4-log reduction in Salmonella 

bacteria. The revised reporting burden 

regarding DV users is addressed in the 

section below titled Paperwork 

Reduction Act. 

Two commenters requested that the 

rule be clarified to specify that process 

authorities may be employees of a 

manufacturer, which is similar to 

process authorities for low-acid canned 

foods. USDA concurs, but notes that it 

is essential to ensure that process 

authorities act in a neutral, unbiased 

manner for both manufacturers and 

handlers. Accordingly, paragraph (b)(3) 

in § 981.442 has been modified to 

specify that process authorities may be 

employees of the entity for which they 

are conducting validation. 

The rule has also been clarified to 

specify that DV auditors may not be 

employees of manufacturers they are 

auditing. It is important that a third 

party perform the audit to ensure the 

integrity of the DV program. 

Accordingly, paragraph (b)(6)(i)(D) in 

§ 981.442 has been modified to specify 

that DV auditors may not be employees 

of the entity for which they are 

conducting an audit. 

Two commenters also suggested 

adding language to the regulatory text 

that clarifies, as the preamble does, the 

criteria that process authorities must 

meet in order to be approved by the 

TERP. This criteria includes the 

following: (1) Knowledge about the 

equipment used for the treatment 

process; (2) experience in conducting 

appropriate studies to determine the 

ability of the equipment to deliver the 

appropriate treatment (such as heat 

penetration or heat distribution); and (3) 

able to determine that sufficient data 

has been gathered to identify the critical 

factors needed to ensure the quality of 

the final product. Accordingly, 

paragraph (3) in the new § 981.442(b) 

has been modified accordingly. 

The Board commented that the rule be 

clarified to specify that persons, not an 

organization, must submit applications 

for approval as process authorities. It is 

the Board’s intent that persons, not 

organizations, be approved process 

authorities. The Board wants to ensure 

that persons conducting validation are 

qualified to do so. USDA concurs with 

the comment. Paragraph (3) in the new 

§ 981.442(b) has been modified 

accordingly. 

The Board also commented that the 

rule be clarified to specify that, under 

the DV program, almonds must be 

shipped by handlers directly to 

approved manufacturer locations where 

such almonds will be treated. The Board 

contends that, without direct shipment, 

it would be impossible to ensure that 

almonds were being shipped to a facility 

where treatment would occur. Indirect 

shipments to third parties could lose 

identity and be difficult to track. USDA 

concurs with the comment. While a 

third party may be involved in the 

transaction, shipments to a third party 

and then to a manufacturing location are 

not permitted under the DV program. 

Paragraph (b)(6)(i) of § 981.442 has been 

modified accordingly. 

Related to the issue of direct DV 

shipments, one commenter stated that 

two small roasters indicated to him they 

would like to see the rule revised to 

allow use of a custom vendor under the 

DV program. USDA assumes this means 

that the almonds would be shipped 

outside the production area to a nonmanufacturing entity or third party for 

treatment. Based on the reasons stated 

in the preceding paragraph regarding 

the need to track shipments to approved 

manufacturer locations, the comment is 

denied. 

Two commenters provided 

recommendations regarding the 

frequency of USDA audits for handlers 

under the audit-based verification 

program. In its comment, the Board 

agreed that audit frequency be tied to 

handler performance, and suggested 

that, during the first year, audits be 

conducted during month 1, 3, 6, and 12. 

If all procedures are in place and 

documentation is accurate, in the 

second year, audits should only be 

conducted once every 6 months. 

Another commenter suggested that two 

audits be conducted for the first year, 

but less frequently in subsequent years 

when the program is ongoing unless 

equipment changes are made to the 

technology used by the handler; the 

commenter suggested audits every 24 

months in subsequent years. 

USDA has taken these suggestions 

under consideration in development of 

its handler audit plan. However, 

handler audit frequency is not a part of 

the regulatory text of this rule. 

Accordingly, no changes have been 

made to the proposed rule based on 

these comments. 

One commenter requested that the 

Board (TERP) provide process 

authorities critical ranges, or minimum 

standards, for variables and conditions 

that are critical to PPO and other 

treatment processes. USDA understands 

that it is the Board’s intent to make this 

information available to process 

authorities and other interested parties 

(i.e., equipment manufacturers, 

handlers, or scientists). Paragraph (b)(3) 

of § 981.442 is modified accordingly. 

Related to validation, one commenter 

stated that, to-date, there is no surrogate 

organism for validating dry roasting 

processes. This is correct. USDA 

understands that the Board continues to 

fund research for non-pathogenic 

surrogates that could be used for 

validating both moist and dry heat 

treatment processes. Until these are 

available, validation for moist and dry 

heat processes must be done with 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15031 

Salmonella bacteria. Validation with 

live Salmonella is not necessary for 

PPO, blanching, or oil roasting because 

the Board has developed specific 

protocols and parameters for these 

processes. 

Two commenters suggested that the 

rule be modified to specify time frames 

for the approval of process authorities; 

one suggested a 45-day time frame for 

approval, and one suggested a 30-day 

time frame for approval, and 2 weeks for 

appeals. One of the commenters also 

suggested time frames for approval of 

applications for DV users and DV 

auditors—30 day time frame for 

approval, and 2 weeks for appeals. 

Timely review of these applications is 

important. USDA will work with the 

Board to ensure quick review and 

response. However, it is not necessary to 

specify time frames within the 

regulation. Thus, these comments are 

denied. 

One commenter suggested that DV 

users be audited no more than once 

every 2 years. Although not specified in 

the regulatory language, the preamble 

indicates that DV users will be audited 

within 1–2 months after the start of 

treatments, and at least once every 12 

months thereafter. An annual audit of 

DV users is appropriate to maintain the 

integrity of the mandatory program. 

Thus, the comment is denied. 

Three commenters expressed concern 

with the impact of treatments on the 

quality, shelf-life, and/or sensory 

characteristics of almonds. One 

contends that the Board’s quality 

research is still ongoing. Another 

contends that treated and untreated 

almonds should be comparable in terms 

of taste, nutritional composition, 

product performance, color, appearance, 

and shelf-life; the commenter requested 

that the Board or TERP require 

extensive product testing of any 

potential new technology to assure the 

consuming public that such almonds are 

materially unchanged in regard to their 

eating quality. 

In early 2006, the Board allocated $1 

million towards a project to ensure that 

appropriate treatment resulted in no 

significant degradation of the almonds. 

The Board formed a team comprised of 

manufacturers, handlers, technical 

experts, and Board staff to develop the 

parameters of the research project and 

evaluate the results. Control almonds 

were compared with almonds that were 

subjected to PPO and two different 

moist heat treatments. Control and 

treated almonds were also roasted. The 

Board indicated it its comments that the 

team met in January 2007 and reviewed 

the following findings. There were no 

indications to-date of significant 

degradation or product deterioration 

when comparing treated samples with 

control samples. Data presented by a 

confectionary manufacturer regarding a 

pilot trial with treated, consumer ready 

product indicated that the product 

chemistry does not present any 

evidence of degradation in raw or 

roasted almonds. Also, as mentioned 

earlier, one commenter who was 

involved in a recall contends that, based 

on his company’s experience with 

treatments, there has been no noticeable 

impact on product shelf-life, roasting, or 

flavor to consumers. No changes have 

been made to the proposed rule based 

on these comments. 

One commenter expressed concern 

with the treatment cost estimates in the 

proposed rule. Costs for steam and PPO 

treatments were estimated between 

$0.02—$0.07 per pound. The 

commenter represents confectionary 

companies and contends that costs to its 

members would be slightly higher, 

depending on broker fees and the 

volume of almonds purchased. The 

commenter estimates that there could be 

an additional cost of $0.05 to $0.10 per 

pound for treated almonds purchased by 

small and medium confectionary 

companies that purchase lesser volumes 

of almonds through brokers. 

While costs to these buyers could be 

slightly higher if they purchased treated 

almonds, the benefits of this rulemaking 

action outweigh the costs. Additionally, 

confectionary companies will still be 

able to purchase untreated almonds. No 

changes have been made to the 

proposed rule based on this comment. 

Several of the comments addressed 

PPO. One commenter contends that PPO 

is not permitted to-date in Canada, the 

European Union (EU), or Mexico. While 

it is true that PPO is not permitted in 

the EU and Canada, it is permitted in 

Mexico. Regarding shipments to the EU, 

under the mandatory program, handlers 

may ship almonds untreated to the EU, 

provided such almonds are labeled 

‘‘unpasteurized.’’ Almonds shipped to 

Canada can be treated with one of the 

other available technologies, or can be 

shipped untreated to DV users in that 

country. No changes have been made to 

the proposed rule based on these 

comments. 

One of the commenters stated that 

they support pasteurization, but believe 

it should not be at the handler level, and 

questioned the authority to impose such 

a requirement through this rulemaking. 

The commenter contends that the safety 

of almond-containing products can be 

assured by treating almonds after they 

leave control of the handler, and that 

later treatment furthers food safety 

objectives by affording less opportunity 

for re-contamination of almonds. The 

commenter argues that only treated 

almonds should be sold to those who 

plan to sell them to consumers as raw 

or natural almonds. 

USDA is implementing this 

rulemaking action under the quality 

control authority contained in the 

almond marketing order. Under the Act, 

the authorizing statute for all marketing 

orders, regulations may only be 

implemented at the handler level. Thus, 

no changes have been made to the 

proposed rule based on this comment. 

One of the commenters indicated his 

support for 100 percent pasteurization 

for all almonds. He stated that, given the 

food safety risks, available control 

technologies and protocols, he strongly 

encourages USDA to make almond 

pasteurization mandatory for all 

almonds. 

As stated earlier in this rule, the 

Board’s initial proposal to USDA in 

February 2006 would have ultimately 

required handlers to treat all almonds 

prior to shipment. However, concerns 

were raised by various parties, 

including manufacturers, handlers, and 

foreign countries, regarding the 

temporary nature of the DV program, 

and the requirement that all exported 

almonds be treated prior to shipment. 

The Board ultimately revised its 

proposal to remove the proviso 

regarding discontinuance of the DV 

program, to allow untreated almonds to 

be shipped to locations outside the U.S., 

Canada, or Mexico, and to require that 

all containers of untreated almonds be 

prominently identified with the term 

‘‘unpasteurized.’’

Although this rule does not mandate 

treatment for all California almonds, it 

will help to ensure consumers receive a 

good quality product, while at the same 

time addressing global customer needs. 

No changes will be made to the rule 

based on this comment. 

One commenter asked for USDA’s 

assistance in getting PPO approved for 

use in all export markets. The 

commenter also asked USDA to pursue 

avenues to provide $3–$5 million to the 

almond industry over the next 5 years 

for research to continue development of 

additional food safety issues, including 

aflatoxin and pasteurization. These 

requests are outside the scope of this 

rulemaking action. Thus, no changes 

have been made to the proposed rule 

based on this comment. 

Comments Opposed or Raising Other 

Issues 

The three comments opposed to the 

rule were submitted by small handlers 

and one was submitted by an 

agricultural consultant. All of the 


cprice-sewell on PROD1PC66 with RULES
15032 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

commenters contend that the rule will 

put small handlers out of business. One 

small handler said that 40 percent of his 

shipments are brown skin, and 60 

percent are manufacturered. Almost all 

of his sales are domestic, with some 

product shipped to Canada and Mexico. 

Two commenters said that their 

businesses were geared toward 

providing product to buyers and 

consumers quickly. Both of these 

commenters contend that the 

technologies are too expensive for small 

handlers. Both also expressed concern 

with the cost of contracting out for 

treatment. One stated that having 

product treated ahead of time is 

problematic because one may not know 

the container-size that buyers want prior 

to treatment. Concern was also 

expressed with the quality of treated 

almonds, stating that there are only two 

methods of treatment to-date—PPO and 

steam (moist heat). One commenter also 

contends that consumers should have a 

choice to buy raw or processed 

almonds, and that labeling almonds as 

non-pasteurized would be acceptable to 

many. 

USDA has evaluated the impact of 

this rulemaking action on small 

handlers. There is an added expense for 

handlers who ship primarily domestic 

to entities that are not DV users. Their 

almonds must be treated prior to 

shipment. Such handlers must evaluate 

their own business situation to 

determine the merits of investing in 

treatment equipment or contracting out 

for treatment. As previously stated, PPO 

treatment is currently available on a 

contract basis at $0.04–$0.05 per pound 

(including transportation to the facility). 

Also, the Board continues to fund 

research projects to develop additional 

treatment methods. USDA understands 

the challenges facing small handlers; 

however, USDA is also concerned about 

the impact of another Salmonella 

outbreak linked to almonds on the 

industry as a whole. USDA supports the 

Board’s proposal for a mandatory 

treatment program for almonds. 

The concern raised regarding the 

impact of treatments on the quality of 

almonds was addressed earlier in this 

document. Preliminary results of a 

comprehensive study conducted by the 

Board in conjunction with 

manufacturers and handlers, has shown 

no significant degradation in the quality 

or shelf-life of almonds. Again, no 

changes have been made to the 

proposed rule based on concerns 

regarding quality. 

In response to the comment that 

consumers should have a choice to buy 

raw or processed almonds, and the 

suggestion that almonds be labeled as 

non-pasteurized, USDA assumes that 

the commenter means labeling at the 

consumer level. The Act provides 

authority for requirements under a 

marketing order at the handler level, not 

the consumer level. Thus, no changes 

have been made to the proposed rule 

based on this comment. 

Two comments were submitted by a 

small handler and a collective group of 

three handlers/growers requesting 

delayed implementation of the rule. The 

proposed rule stated that the mandatory 

program would take effect on August 1, 

2007, the start of the 2007–08 crop year, 

with handlers submitting their 

treatment plans for 2007–08 by May 1, 

2007. The three growers/handlers raised 

concerns about available treatment 

capacity, and contend that it is 

logistically impossible to implement the 

program by August 1, 2007. They 

expressed concern with potentially only 

a 3-month lag between publication of 

the final rule and implementation of the 

program. The small handler requested 

delayed implementation until issues for 

small handlers are addressed 

guaranteeing that they will not be forced 

out of business. 

Regarding capacity, the commenters 

contend that more technologies are 

needed and believe that, once the rule 

becomes mandatory, more companies 

will likely submit protocols to TERP for 

review acceptance. The commenters 

summarized their understanding of 

available technologies, and contend that 

the mandatory program would restrict 

commerce due to insufficient capacity. 

The comment contends the following. 

There are three moist heat processes 

accepted by the TERP. The latest 

process (A) recently received 

‘‘approval’’ for one chamber, and is 

operating at one facility in central 

California. Another process (B) has been 

TERP-accepted with no systems built, 

and the third (C) has three systems in 

place primarily for private use, and 

limited capacity for outside custom 

volume. Regarding PPO, the 

commenters contend there are limited 

facilities in California. The largest 

facility available is in Nevada, outside 

the production area of California. They 

contend that, due to capacity 

constraints, only a fraction of the 

needed PPO space is available. The 

comment also raises concerns regarding 

fees and availability for custom 

treatment, particularly if the time frame 

between publication of the final rule 

and implementation of the program is 

only 3 months. If a handler were going 

to build his/her own facility, the 

comment estimates that construction 

and validation could take more than 1 

year. 

In response to concerns regarding 

technology and available capacity, the 

comment is correct in that there are 

three moist heat processes accepted todate by the TERP. However, as shown 

below in Table 7, moist heat capacity is 

estimated at a minimum 652 million 

pounds. The comment is correct that 

one chamber for Process A in central 

California has been validated and is in 

operation (100 million pound capacity). 

However, that machine has two other 

chambers to be validated. Once 

validation is completed, an additional 

200 million pounds of capacity will be 

available. Regarding process B, the 

comment is incorrect that a machine has 

not yet been built. In fact, a machine has 

been built and is being installed (88 

million pound capacity). For process C, 

one machine is operational, and in-plant 

validation is starting on two additional 

machines (another 176 million pounds 

in capacity). 

TABLE 7.—MOIST HEAT CAPACITY

Moist 

heat 

process 

Status Capacity 

(pounds) 

A ............ —3 chambers for 

one machine in 

one plant, 1 

chamber validated and operational.

1 100 

—Other 2 chambers to be validated.

1 200 

B ............ —1 machine being 

installed (validated in industrial warehouse).

1 88 

C ............ —1 machine validated and operational.

1 88 

—2 machines in 

process of inplant validation.

1 176 

Total capacity 652 million. 

1 In millions. 

Regarding PPO, the comment is 

correct in that handlers must treat their 

almonds within the production area of 

California. However, the comment is 

incorrect that PPO capacity in California 

is limited. Board data indicates 

available PPO capacity within California 

of at least 250 million pounds. Thus, 

total capacity from moist heat and PPO 

is estimated at over 800 million pounds. 

Additional machines and equipment are 

likely to be built in the future. Raw 

domestic almond shipments (240 

million pounds) and shipments to 

Canada and Mexico (36.7 million 

pounds) total about 276 million pounds. 

Thus, there will be more than sufficient 

capacity to treat all of this production. 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15033 

No changes have been made to the 

proposed rule due to concerns regarding 

capacity. 

In response to the suggestion that 

implementation of the program be 

delayed, USDA believes this has merit. 

USDA concurs that sufficient time is 

needed between publication of the final 

rule and implementation of the 

mandatory program. Once the final rule 

is published, the Board must circulate 

applications to prospective process 

authorities, DV users, and DV auditors. 

Time is needed for application 

submission, review, and approval. 

Treatment technology and equipment 

must be validated by Board-approved 

process authorities. Handlers must 

develop and submit treatment plans to 

USDA and the Board for review and 

approval. Small handlers without 

treatment equipment must arrange for 

outsourcing treatment and may have to 

make adjustments in their business 

practices. For example, they may have 

to treat their almonds ahead of time, 

work with their customers to assess 

their needs regarding container size, etc. 

earlier than in the past, or perhaps try 

to develop new customers that could 

qualify as DV users. 

USDA has determined that about a 5- 

month lag time between publication of 

the final rule and implementation of the 

program is appropriate. USDA assessed 

the merits of waiting another complete 

crop year for implementation, August 

2008, and believes that such a delay 

would not be warranted. USDA 

considered a September 1, 2007, date for 

implementation. New crop shipments 

begin September 1, so this date would 

ensure that 2007–08 crop almonds are 

covered under the program. 

Accordingly, in the new § 981.442(b), 

the introductory text in paragraph (b) is 

modified to specify a September 1, 

2007, implementation date, and 

paragraph (b)(4)(i) is modified to specify 

that, for the 2007–08 crop year, handler 

treatment plans must be submitted by 

May 31, 2007, rather than May 1, 2007. 

Another commenter contends that the 

DV program is the only viable and 

rational option to adopt and maintain, 

and supports the labeling of untreated 

product shipped to approved DV users 

within the U.S., Canada, and Mexico, 

and outside these areas, provided 

product is labeled. The commenter does 

not support 100 percent treatment for all 

almonds when only 5 percent of 

almonds are consumed raw. In 

response, the rule provides for a DV 

program, labeling of untreated product, 

and does not require all almonds to be 

treated prior to shipment. 

Another commenter suggested that 

the word ‘‘pasteurized’’ or 

‘‘unpasteurized’’ on containers be both 

in English and in the language used by 

the receiving country. The Board 

addressed this concern in its comment. 

The Board contends that translating the 

word ‘‘unpasteurized’’ on containers is 

not feasible because it is not always 

clear what the final destination will be. 

The Board suggests that all markings on 

containers be in English for ease of 

translation if so required by the country 

into which the goods will enter. USDA 

concurs with the Board. Regarding the 

word ‘‘pasteurized,’’ the regulation does 

not require treated containers of 

almonds to be labeled. No changes have 

been made to the proposed rule based 

on this comment. 

Another commenter contends that the 

industry’s concern regarding California 

almonds being shipped back into the 

U.S. from Canada and Mexico is 

unfounded. He contends that freight 

costs and difficulties with getting the 

goods through customs would prohibit 

transshipments. The Board discussed 

this issue in depth prior to making its 

recommendation to treat Canada and 

Mexico similar to the U.S. under the 

mandatory program. The Board 

concluded that transshipments could be 

a problem. USDA concurs with the 

Board. The comment is denied. 

Paperwork Reduction Act 

The proposed rule published on 

December 6, 2006, provided for a 60-day 

comment period on the reporting 

requirements contained in the rule. That 

period ended on February 5, 2007. Four 

comments were received that concern 

reporting requirements and are 

addressed in the Analysis of Comments 

section above. Based on these 

comments, the reporting burdens were 

revised for the applications for process 

authorities, DV users, and DV program 

auditors. These entities must submit an 

initial application to the Board. For 

subsequent years, rather than submitting 

new applications, approved applicants 

with no changes to their initial 

applications must send the Board a 

letter, signed and dated, indicating there 

are no changes to the application the 

Board has on file. Additionally, DV 

users must submit with their 

application documentation to verify that 

their treatment technology and 

equipment were validated by a Boardapproved process authority, and to 

demonstrate appropriate treatment 

processes. The revised reporting 

burdens are as follows. 

Regarding ABC Form No. 51, 

‘‘Application for Process Authority for 

Almonds,’’ it is estimated that it will 

take a process authority about 2 hours 

per response (same as proposal) for the 

first year of regulation, but only .25 

hours per response each year thereafter 

(a reduction of 1.75 hours), and that 25 

process authorities will respond. Thus, 

the total annual reporting burden for the 

form is estimated at 50 hours (same as 

proposal) for the first year of regulation, 

and 6.25 hours for each year thereafter 

(a reduction of 43.75 hours). 

Regarding ABC Form No. 52, 

‘‘Application for Direct Verifiable (DV) 

Program for Further Processing of 

Untreated Almonds,’’ it is estimated it 

will take a manufacturer about 1.5 hours 

per response (.5 hours more than 

initially proposed) for the first year of 

regulation. The additional .5 hours 

addresses the time for DV users to 

include documentation with their 

application to verify that their treatment 

technology and equipment were 

validated by a Board-approved process 

authority. It is estimated that it will take 

a manufacturer only .25 hours per 

response each year thereafter, and that 

53 manufacturers will respond each 

year. Thus, the total annual reporting 

burden for the form is estimated at 79.5 

hours (26.5 hours more than initially 

proposed) for the first year of regulation, 

and 13.25 hours for each year thereafter 

(a reduction of 66.25 hours). 

Regarding ABC Form No. 53, 

‘‘Application for Direct Verifiable (DV) 

Program Auditors,’’ it is estimated it 

will take a DV auditor about 1 hour per 

response for the first year of regulation, 

but only .25 hours per response (a 

reduction of .75 hours) each year 

thereafter, and that 50 auditors will 

respond. Thus, the total annual 

reporting burden for the form is 

estimated at 50 hours for the first year 

of regulation, and 12.5 hours for each 

year thereafter (a reduction of 37.5 

hours). 

As previously stated, in accordance 

with the PRA, the information 

collection was submitted to the OMB 

and was approved under OMB Control 

No. 0581–0242, Almonds Grown in 

California. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

fv/moab.html. Any questions about the 

compliance guide should be sent to Jay 

Guerber at the previously mentioned 

address in the FOR FURTHER INFORMATION

CONTACT section. 

After consideration of all relevant 

matters presented, including the 

information and recommendation 

submitted by the Board and other 

available information, it is hereby found 

that this rule, as hereinafter set forth, 

will tend to effectuate the declared 

policy of the Act. 


cprice-sewell on PROD1PC66 with RULES
15034 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

Pursuant to 5 U.S.C. 553, it is also 

found and determined that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because handler treatment plans for the 

2007–08 crop year are due to the Board 

and USDA by May 31, 2007, and 

mandatory compliance with this rule 

begins September 1, 2007. Handlers are 

aware of this action which was 

unanimously recommended at a public 

meeting. Additionally, a 45-day 

comment period was provided for in the 

proposed rule, and all comments 

received were addressed herein. 

List of Subjects in 7 CFR Part 981 

Almonds, Marketing agreements, 

Nuts, Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, 7 CFR part 981 is amended as 

follows: 

PART 981—ALMONDS GROWN IN 

CALIFORNIA 

■ 1. The authority citation for 7 CFR 

part 981 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. Section 981.442 is amended by 

redesignating the undesignated text 

following paragraph (a)(7)(iv) as 

paragraph (a)(7)(v) and by adding 

paragraph (b) to read as follows: 

§ 981.442 Quality control. 

* * * * * 

(b) Outgoing. Pursuant to § 981.42(b), 

beginning September 1, 2007, and 

except as provided in § 981.13 and in 

paragraph (b)(6) of this section, handlers 

shall subject their almonds to a 

treatment process or processes prior to 

shipment to reduce potential 

Salmonella bacteria contamination in 

accordance with the provisions of this 

section. 

(1) Treatment process. Treatment 

processes shall utilize technologies that 

have been determined to achieve in total 

a minimum 4-log reduction of 

Salmonella bacteria in almonds, 

pursuant to a letter of determination 

issued by the Food and Drug 

Administration (FDA), or acceptance by 

a scientific review panel as identified by 

the Board (Technical Expert Review 

Panel or ‘‘TERP’’). Such panel shall be 

approved at least annually by the Board 

prior to the beginning of each crop year, 

or as needed during the crop year. 

(2) On-site versus off-site treatment. 

Handlers shall subject almonds to a 

treatment process or processes prior to 

shipment either at their handling 

facility (on-site), or at an off-site 

treatment facility located within the 

production area. Transportation of 

almonds by a handler to an off-site 

treatment facility shall not be deemed a 

shipment. 

(3) Validation by process authorities. 

Handlers shall only use, or transport 

their almonds to off-site treatment 

facilities that use treatment processes 

that have been validated by a Boardapproved process authority. Treatment 

technology and equipment that have 

been modified to a point where 

operating parameters such as time, 

temperature, or volume change, shall be 

revalidated. 

(i) Validation means that the 

treatment technology and equipment 

have been demonstrated to achieve in 

total a minimum 4-log reduction of 

Salmonella bacteria in almonds. 

(ii) A process authority is a person 

that has expert knowledge of 

appropriate processes for the treatment 

of almonds as defined in paragraph 

(b)(1) of this section, and meets the 

following criteria: 

(A) Knowledge about the equipment 

used for the treatment process; 

(B) Experience in conducting 

appropriate studies to determine the 

ability of the equipment to deliver the 

appropriate treatment (such as heat 

penetration or heat distribution); and 

(C) Able to determine that sufficient 

data has been gathered to identify the 

critical factors needed to ensure the 

quality of the final product. 

(iii) Process authorities may be 

employees of the entity for which they 

are conducting validation. The Board 

shall provide process authorities 

specific protocols and parameters for 

treatment processes that are FDA 

determined or TERP accepted. 

(iv) Process authorities must submit 

an initial application to the Board on 

ABC Form No. 51, ‘‘Application for 

Process Authority for Almonds,’’ and be 

approved by the TERP. Should the 

applicant disagree with the TERP’s 

decision concerning approval, the 

applicant may appeal the decision in 

writing to the Board, and ultimately to 

USDA. For subsequent crop years, 

approved applicants with no changes to 

their initial application must send the 

Board a letter, signed and dated, 

indicating that there are no changes to 

the application the Board has on file. 

(v) The TERP may revoke any 

approval for cause. The TERP shall 

notify the process authority in writing of 

the reasons for revoking the approval. 

Should the process authority disagree 

with the TERP’s decision, he/she may 

appeal the decision in writing to the 

Board, and ultimately to USDA. A 

process authority whose approval has 

been revoked must submit a new 

application to the TERP and await 

approval. 

(4) Compliance and verification. In 

accordance with the requirements of 

this paragraph, handlers shall utilize 

either an on-site verification program 

(traditional), or an audit-based 

verification program to ensure that their 

almonds have been subjected to a 

treatment process to reduce Salmonella 

bacteria prior to shipment. Each handler 

may decide which verification program 

would be the most cost-effective for his 

or her operation. 

(i) By May 31, each handler shall 

submit to the Board a Treatment Plan 

for the upcoming crop year. A 

Treatment Plan shall describe how a 

handler plans to treat his or her 

almonds, and must address specific 

parameters as outlined by the Board for 

the handler to ship almonds. Such plan 

shall be reviewed by the Board, in 

conjunction with the inspection agency, 

to ensure it is complete and can be 

verified, and be approved by the Board. 

Almonds sent by a handler for treatment 

to an off-site facility affiliated with 

another handler shall be subject to the 

approved Treatment Plan utilized at that 

facility. Handlers shall follow their own 

approved Treatment Plans for almonds 

sent to an off-site facility that is not 

affiliated with another handler. 

(ii) Handlers utilizing an on-site 

verification program shall cause the 

inspection agency to verify that their 

Treatment Plans have been followed, 

and that their almonds have been 

subjected to a treatment process that has 

been validated by a Board-approved 

process authority. Such handlers shall 

submit, or cause to be submitted, a 

verification report to the Board. The 

inspection agency must physically 

observe the treatment process to issue 

such report. 

(iii) Handlers utilizing an audit-based 

verification program shall be subject to 

periodic audits conducted by the 

inspection agency. The inspection 

agency shall provide copies of the audit 

report to the Board. Handlers who do 

not comply with an audit-based 

verification program shall be required to 

revert to an on-site verification program. 

(iv) Interhandler transfers of almonds 

may or may not be treated prior to 

transfer. Handlers receiving untreated 

almonds from another handler shall be 

responsible for treating the product. 

Handlers receiving treated almonds 

from another handler must have 

procedures outlined in their Treatment 

Plan addressing how the integrity of the 

treated almonds will be maintained. In 

all instances involving interhandler 

transfers, the receiving handler shall be 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15035 

responsible for ensuring that the 

almonds are treated prior to shipment 

and maintaining documentation to that 

effect. 

(v) An off-site treatment facility that 

does not handle almonds, pursuant to 

§ 981.16, shall provide access to the 

inspection agency and Board staff for 

verification of treatment and review of 

treatment records. A treatment process 

at an off-site treatment facility that has 

been validated by a Board approved 

process authority is deemed to be 

approved by the Board for handler use. 

The Board may revoke any such 

approval for cause. The Board shall 

notify the off-site treatment facility of 

the reasons for revoking the approval. 

Should the off-site facility disagree with 

the Board’s decision, it may appeal the 

decision in writing to USDA. Handlers 

may treat their almonds only at off-site 

treatment facilities that have been 

deemed to be approved by the Board. 

(5) Records. Handlers shall maintain 

records and documentation that will be 

subject to audit by the Board for the 

purpose of verifying compliance with 

this section. Records must be 

maintained for two full years following 

the end of the crop year, and must 

identify lots from the point of treatment 

forward to the point of shipment by the 

handler. Lot identification shall also 

provide the ability to differentiate 

treated from untreated product. Off-site 

treatment facilities that do not handle 

almonds pursuant to § 981.16, shall 

maintain treatment records for 2 full 

years following the end of a crop year 

and make such records available to the 

Board. 

(6) Exemptions. Handlers may ship 

untreated almonds under the following 

conditions. For purposes of this section, 

container means a box, bin, bag, carton, 

or any other type of receptacle used in 

the packaging of bulk almonds. 

(i) Handlers may ship untreated 

almonds for further processing directly 

to manufacturers located within the 

U.S., Canada or Mexico. This program 

shall be termed the Direct Verifiable 

(DV) program. Handlers may only ship 

untreated almonds to manufacturers 

who have submitted ABC Form No. 52, 

‘‘Application for Direct Verifiable (DV) 

Program for Further Processing of 

Untreated Almonds,’’ and have been 

approved by the TERP. Such almonds 

must be shipped directly to approved 

manufacturing locations, as specified on 

Form No. 52. Such manufacturers DV 

users must submit an initial Form No. 

52 to the Board and be approved by the 

TERP. Should the applicant disagree 

with the TERP’s decision concerning 

approval, it may appeal the decision in 

writing to the Board, and ultimately to 

USDA. For subsequent crop years, 

approved applicants with no changes to 

their initial application must send the 

Board a letter, signed and dated, 

indicating that there are no changes to 

the application the Board has on file. 

The TERP may revoke any approval for 

cause. The TERP shall notify the 

manufacturer in writing of the reasons 

for revoking the approval. Should the 

manufacturer disagree with the TERP’s 

decision, it may appeal the decision in 

writing to the Board, and ultimately to 

USDA. A manufacturer whose approval 

has been revoked must submit a new 

application to the TERP and await 

approval. The Board shall issue a DV 

User code to an approved manufacturer. 

Handlers must reference such code in 

all documentation accompanying the lot 

and identify each container of such 

almonds with the term ‘‘unpasteurized.’’

Such lettering shall be on one outside 

principal display panel, at least 1⁄2 inch 

in height, clear and legible. If a third 

party is involved in the transaction, the 

handler must provide sufficient 

documentation to the Board to track the 

shipment from the handler’s facility to 

the approved DV user. While a third 

party may be involved in such 

transactions, shipments to a third party 

and then to a manufacturing location are 

not permitted under the DV program. 

Approved DV Users shall: 

(A) Subject such almonds to a 

treatment process or processes using 

technologies that achieve in total a 

minimum 4-log reduction of Salmonella 

bacteria as determined by the FDA, 

accepted by the TERP, or established by 

a process authority approved in 

accordance with and subject to the 

provisions and procedures of paragraph 

(b)(6) of this section. Establish means 

that the treatment process and protocol 

have been evaluated to ensure the 

technology’s ability to deliver a lethal 

treatment for Salmonella bacteria in 

almonds to achieve a minimum 4-log 

reduction; 

(B) Identify the manufacturing 

locations where treatment will occur; 

(C) Have their treatment technology 

and equipment validated by a Boardapproved process authority, and provide 

documentation with their DV 

application to verify that their treatment 

technology and equipment have been 

validated by a Board-approved process 

authority. Such documentation may 

include, but not be limited to, a letter 

from such process authority certifying 

the validation. Such documentation 

shall be sufficient to demonstrate that 

the treatment processes and equipment 

achieve a 4-log reduction in Salmonella 

bacteria. Treatment technology and 

equipment that have been modified to a 

point where operating parameters such 

as time, temperature, or volume change, 

shall be revalidated; 

(D) Have their technology and 

procedures verified by a Boardapproved DV auditor to ensure they are 

being applied appropriately. A DV 

auditor may not be an employee of the 

manufacturer that he/she is auditing. 

DV auditors must submit a report to the 

Board after conducting each audit. DV 

auditors must submit an initial 

application to the Board on ABC Form 

No. 53, ‘‘Application for Direct 

Verifiable (DV) Program Auditors,’’ and 

be approved by the TERP. Should the 

applicant disagree with the TERP’s 

decision concerning approval, it may 

appeal the decision in writing to the 

Board, and ultimately to USDA. For 

subsequent crop years, approved DV 

auditors with no changes to their initial 

application must send the Board a letter, 

signed and dated, indicating that there 

are no changes to the application the 

Board has on file. The TERP may revoke 

any approval for cause. The TERP shall 

notify the DV auditor in writing of the 

reasons for revoking the approval. 

Should the DV auditor disagree with the 

TERP’s decision, it may appeal the 

decision in writing to the Board, and 

ultimately to USDA. A DV auditor 

whose approval has been revoked must 

submit a new application to the TERP 

and await approval; 

(E) Maintain all records regarding 

validation and verification of treatment 

methods, processing, and product 

traceability. Such records shall be 

retained for two years and shall be made 

available for review by the Board; and, 

(F) Ship any almonds which will not 

be treated to a handler, to another 

approved DV user, to locations outside 

the U.S., Canada, and Mexico 

(containers must remain identified with 

the term ‘‘unpasteurized’’), as specified 

in § 981.442(b)(6)(i), or dispose of such 

almonds in non-edible channels. 

(ii) Handlers may ship untreated 

almonds directly or through a third 

party to locations outside the U.S., 

Canada, and Mexico, provided that each 

container of such almonds is identified 

with the term ‘‘unpasteurized.’’ Such 

lettering shall be on one outside 

principal display panel, at least 1⁄2 inch 

in height, clear and legible. If a third 

party is involved in the transaction, the 

handler must provide sufficient 

documentation to the Board to track the 

shipment from the handler’s facility to 

the importer in the foreign country. 

(7) Other restrictions. The provisions 

of this section do not supersede any 

restrictions or prohibitions regarding 

almonds grown in California under the 

Federal Food, Drug and Cosmetic Act, 


cprice-sewell on PROD1PC66 with RULES
15036 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

or any other applicable laws or 

regulations or the need to comply with 

applicable food and sanitary regulations 

of city, county, State or Federal 

agencies. 

Dated: March 26, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 07–1557 Filed 3–27–07; 10:50 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 23 

[Docket No. CE255; Special Conditions No. 

23–195A–SC] 

Special Conditions: Aviation 

Technology Group (ATG), Inc., Javelin 

Model 100 Series Airplane; Flight 

Performance, Flight Characteristics, 

and Operating Limitations 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Amended final special 

conditions. 

SUMMARY: These amended special 

conditions are issued for the Aviation 

Technology Group (ATG), Inc., Javelin 

Model 100 Series airplane. This is an 

amendment to special condition 23–

195–SC, which was published on 

February 1, 2007 (72 FR 4618), for 

certain novel or unusual design features 

associated with engine location, certain 

performance, flight characteristics and 

operating limitations. The original final 

special conditions were more generic 

and contained requirement language 

that was not necessary for jet airplanes. 

This amendment also corrects several 

references to part 23 sections to be 

consistent with these special conditions. 

This airplane will have a novel or 

unusual design feature(s) associated 

with engine location, certain 

performance, flight characteristics and 

operating limitations necessary for this 

type of airplane. The applicable 

airworthiness regulations do not contain 

adequate or appropriate safety standards 

for this design feature. These special 

conditions contain the additional safety 

standards that the Administrator 

considers necessary to establish a level 

of safety equivalent to airworthiness 

standards applicable to these airplanes. 

DATES: The effective date of these 

special conditions is March 23, 2007. 

FOR FURTHER INFORMATION CONTACT: J. 

Lowell Foster, Federal Aviation 

Administration, Aircraft Certification 

Service, Small Airplane Directorate, 

ACE–111, 901 Locust, Room 301, 

Kansas City, Missouri, 816–329–4125, 

fax 816–329–4090. 

SUPPLEMENTARY INFORMATION: The final 

special conditions with a request for 

comments were published on February 

1, 2007 (72 FR 4618). No comments 

were received. These amended final 

special conditions remove requirement 

language that is not necessary for jet 

airplanes. 

Background 

On February 15, 2005, Aviation 

Technology Group (ATG); 8001 South 

InterPort Boulevard, Suite 310; 

Englewood, Colorado 80112–5951, 

applied for a type certificate for their 

new Model 100 Javelin airplane in 

accordance with the airworthiness 

standards in 14 CFR, part 23. The 

Javelin is a two-place, twin engine, 

turbofan-powered light jet airplane with 

a planned maximum operating altitude 

of 45,000 feet. Part 23 regulations in 

effect on the date of ATG’s application 

do not contain adequate or appropriate 

safety standards for a small, high 

performance jet airplane such as the 

Javelin. In accordance with Small 

Airplane Directorate policy, the safety 

standards for flight performance, flight 

characteristics and operational 

limitations that the Federal Aviation 

Administration (FAA) finds necessary to 

establish an acceptable level of safety 

for this type of airplane are presented in 

this special condition. 

Final special conditions with request 

for comments were issued on January 

24, 2007, and were published on 

February 1, 2007. The comment period 

closed March 5, 2007, and no comments 

were received. However, the original 

issue contained requirement language 

that is not necessary for jet airplanes, 

and this amendment removes that 

language. 

Type Certification Basis 

Under the provisions of 14 CFR, part 

21, § 21.17, ATG must show that the 

Model 100 meets the applicable 

provisions of part 23, as amended by 

Amendment 23–1 through 23–55 

thereto. If the Administrator finds that 

the applicable airworthiness regulations 

(i.e., 14 CFR, part 23) do not contain 

adequate or appropriate safety standards 

for the ATG Model 100 series because 

of a novel or unusual design feature, 

special conditions are prescribed under 

the provisions of § 21.16. 

Special conditions, as appropriate, as 

defined in § 11.19, are issued in 

accordance with § 11.38, and become 

part of the type certification basis in 

accordance with § 21.17(a)(2). 

Special conditions are initially 

applicable to the model for which they 

are issued. Should the type certificate 

for that model be amended later to 

include any other model that 

incorporates the same novel or unusual 

design feature, the special conditions 

would also apply to the other model 

under the provisions of § 21.101(a)(1). 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Model 100 must comply 

with the part 23 fuel vent and exhaust 

emission requirements of 14 CFR, part 

34 and the part 23 noise certification 

requirements of 14 CFR, part 36; and the 

FAA must issue a finding of regulatory 

adequacy pursuant to § 611 of Public 

Law 92–574, the ‘‘Noise Control Act of 

1972.’’

Novel or Unusual Design Features 

ATG intends to certificate the Javelin 

in both utility and acrobatic categories. 

The ATG Javelin Model 100 will 

incorporate the following novel or 

unusual design features: 

• Two-place, tandem configuration. 

• Maximum takeoff weight of 

approximately 6,900 pounds. 

• Design cruise speed of 500 knots 

calibrated airspeed. 

• Two Williams FJ33–4A–18M 

turbofan engines with dual channel 

FADEC controls. 

• Major airframe components 

constructed of carbon fiber composite 

materials. 

• Hydraulically boosted flight control 

system with floor-mounted control 

sticks. 

• Integrated avionics including 

Avidyne displays, autopilot, and flight 

management system. 

Novel features on the ATG Model 100 

include rear mounted turbine engines 

embedded in the fuselage, boosted 

controls, and high-speed, high-altitude 

acrobatic capability. 

Applicability 

As discussed above, these special 

conditions are applicable to the ATG 

Model 100 series. Should ATG apply at 

a later date for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well 

under the provisions of § 21.101(a)(1). 

Conclusion 

This action affects only certain novel 

or unusual design features on ATG 

Model 100 series airplanes. It is not a 

rule of general applicability and affects 

only the applicant who applied to the 

FAA for approval of these features on 

the airplane. 


cprice-sewell on PROD1PC66 with RULES