28872 Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 

encouraged to participate in the 

Committees’ deliberations on all issues. 

Like all Committee meetings, the 

February 19, 2009, meetings were public 

meetings and entities of all sizes were 

able to express views on this issue. 

Finally, interested persons are invited to 

submit information on the regulatory 

and informational impacts of this action 

on small businesses. 

This action imposes no additional 

reporting or recordkeeping requirements 

on either small or large handlers. 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. 

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. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this rule. 

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 

material presented, including the 

information and recommendation 

submitted by the Committee 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. 

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

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect, and that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) The 2009–10 fiscal period 

began March 1, 2009, and the marketing 

orders require that the rates of 

assessment for each fiscal period apply 

to all assessable nectarines and peaches 

handled during such fiscal period; (2) 

the Committees need to have sufficient 

funds to pay its expenses which are 

incurred on a continuous basis; (3) 

handlers are aware of this action which 

was recommended by the Committees at 

public meetings and is similar to other 

assessment rate actions issued in past 

years; and (4) this interim final rule 

provides a 60-day comment period, and 

all comments timely received will be 

considered prior to finalization of this 

rule. 

List of Subjects 

7 CFR Part 916 

Marketing agreements, Nectarines, 

Reporting and recordkeeping 

requirements. 

7 CFR Part 917 

Marketing agreements, Peaches, Pears, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, 7 CFR parts 916 and 917 are 

amended as follows: 

■ 1. The authority citation for 7 CFR 

parts 916 and 917 continues to read as 

follows: 

Authority: 7 U.S.C. 601–674. 

PART 916—NECTARINES GROWN IN 

CALIFORNIA 

■ 2. Section 916.234 is revised to read 

as follows: 

§ 916.234 Assessment rate. 

On and after March 1, 2009, an 

assessment rate of $0.0175 per 25-pound 

container or container equivalent of 

nectarines is established for California 

nectarines. 

PART 917—PEACHES GROWN IN 

CALIFORNIA 

■ 3. Section 917.258 is revised to read 

as follows: 

§ 917.258 Assessment rate. 

On and after March 1, 2009 an 

assessment rate of $0.0025 per 25-pound 

container or container equivalent of 

peaches is established for California 

peaches. 

Dated: June 12, 2009. 

Craig Morris, 

Acting Associate Administrator. 

[FR Doc. E9–14280 Filed 6–17–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 981 

[Doc. No. AMS–FV–08–0045; FV08–981–2 

IFR] 

Almonds Grown in California; Revision 

of Outgoing Quality Control 

Requirements 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: This rule revises the outgoing 

quality control regulations issued under 

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 

revises the term ‘‘validation’’ under the 

Salmonella bacteria (Salmonella) 

treatment program by specifying that 

validation data must be both submitted 

to and accepted by the Board’s 

Technical Expert Review Panel (TERP) 

for all treatment equipment prior to its 

use under this program. This will help 

ensure that all treatment equipment 

meets a 4-log reduction of Salmonella in 

almonds. 

DATES: Effective June 19, 2009; 

comments must be received by August 

17, 2009. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this rule. Comments must be 

sent to the Docket Clerk, Marketing 

Order Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA, 1400 

Independence Avenue, SW., STOP 

0237, Washington, DC 20250–0237; Fax: 

(202) 720–8938, or Internet: http:// 

www.regulations.gov. Comments should 

reference the document number and the 

date and page number of this issue of 

the Federal Register and will be 

available for public inspection in the 

Office of the Docket Clerk during regular 

business hours, or can be viewed at: 

http://www.regulations.gov. All 

comments submitted in response to this 

rule will be included in the record and 

will be made available to the public. 

Please be advised that the identity of the 

individuals or entities submitting the 

comments will be made public on the 

Internet at the address provided above. 

FOR FURTHER INFORMATION CONTACT: 

Terry Vawter, Senior Marketing 

Specialist, 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: 

Terry.Vawter@ams.usda.gov, or 

Kurt.Kimmel@ams.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@ams.usda.gov. 

Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 28873 

SUPPLEMENTARY INFORMATION: This 

interim 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 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 interim final rule revises the 

outgoing quality control requirements 

under the Salmonella treatment 

program. This rule revises the term 

‘‘validation’’ by specifying that 

validation data must be both submitted 

to and accepted by the Board’s TERP for 

all treatment equipment prior to its use 

under the program. The TERP consists 

of four scientists, with a representative 

from the Food and Drug Administration 

serving as an ex-officio member. This 

will help ensure that all treatment 

equipment meets a 4-log reduction of 

Salmonella in almonds. This action was 

unanimously recommended by the 

Board at a meeting on May 20, 2008. 

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 product, 

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. 

Section § 981.442(b) of the order’s 

administrative rules and regulations 

provides authority for a mandatory 

treatment program to reduce the 

potential for Salmonella in almonds. A 

mandatory program went into effect in 

September 2007. Specifically, handlers 

must subject their almonds to a 

treatment process that achieves a 

minimum 4-log reduction in Salmonella 

prior to shipment. ‘‘Log reduction’’ 

describes how much bacteria is reduced 

by a treatment process. A 4-log 

reduction decreases bacteria by a factor 

of 10,000 (4 zeros). Handlers may treat 

almonds themselves or transport the 

almonds to off-site facilities for 

treatment. Also, handlers may ship 

untreated almonds to Board-approved 

manufacturers within the U.S., Canada, 

and Mexico who agree to treat the 

almonds appropriately. Handlers may 

also ship untreated almonds to locations 

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

Containers of untreated almonds must 

be labeled ‘‘unpasteurized.’’ 

Paragraph 3 of § 981.442(b) of the 

regulations specifies that treatment 

processes must be validated by a Boardapproved process authority. Paragraph 

(i) of that section defines the term 

‘‘validation’’ to mean that the treatment 

technology and equipment have been 

demonstrated to achieve a 4-log 

reduction. Process authorities run tests 

to ensure this parameter is met. A 

process authority is a person who has 

expert knowledge of appropriate 

processes for the treatment of almonds 

and meets criteria specified in 

paragraph (ii) of that section. 

Currently, the regulation does not 

specify that process authorities submit 

validation data to the Board’s TERP in 

order to ensure that the treatment 

equipment meets the program’s 4-log 

requirement. Thus, the Board 

recommended that the regulation be 

revised accordingly. This will help 

ensure that all treatment equipment 

meets the program’s 4-log requirement. 

Paragraph (3)(i) of § 981.442(b) of the 

regulations issued under the order is 

revised accordingly. 

Initial 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 initial regulatory 

flexibility analysis. 

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 6,200 

producers of almonds in the production 

area and approximately 100 handlers 

subject to regulation under the 

marketing order. Additionally, the 

Board estimates there are about 15 

process authorities and 30 almond 

manufacturers under the Salmonella 

treatment program. 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 $7,000,000. 

Data for the most recently-completed 

crop year indicate that about 50 percent 

of the handlers shipped under 

$7,000,000 worth of almonds. Dividing 

average almond crop value for 2006–07 

reported by the National Agricultural 

Statistics Service of $2.258 billion by 

the number of producers (6,200) yields 

an average annual producer revenue 

estimate of about $364,190. 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 the process 

authorities and almond manufacturers is 

not available, it may be assumed that 

some process authorities and 

manufacturers may be classified as 

small entities. 

This rule revises § 981.442(b)(3)(i) of 

the order’s administrative rules and 

regulations. This rule revises the term 

‘‘validation’’ under the Salmonella 

treatment program to specify that 

validation data must be both submitted 

to and accepted by the TERP for each 

piece of treatment equipment prior to its 

use under the program. This revision 

will help ensure that all treatment 

equipment meets the program’s 4-log 

requirement prior to its use. Authority 

for this action is provided in § 981.42(b) 

of the order. 

Regarding the overall impact of this 

action on affected entities, it is expected 

to be minimal. Validation data is 

28874 Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 

already submitted to the Board’s TERP 

for review. This action simply specifies 

that such data must be accepted by the 

TERP for all treatment equipment prior 

to its use under the program. 

The Board’s Food Quality and Safety 

Committee (committee) met on April 22, 

2008, to consider this change. The 

committee considered maintaining the 

status quo whereby equipment could be 

used under the program that had 

completed validation testing, but had 

not been accepted by the TERP. The 

committee concluded that acceptance 

by the TERP was important in order to 

help ensure that all treatment 

equipment consistently meets the 4-log 

requirement of the program. The Board 

agreed with the committee and 

ultimately recommended that the term 

‘‘validation’’ be revised accordingly. 

This action does not impose any 

additional reporting and recordkeeping 

requirements on California almonds 

handlers, process authorities, or almond 

manufacturers. 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. 

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. 

In addition, USDA has not identified 

any relevant Federal rules that 

duplicate, overlap, or conflict with this 

rule. 

Further, the committee and Board 

meetings where this issue was discussed 

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. The issue 

was discussed at two committee 

meetings in April 2008 and at two Board 

meetings, one in April and one in May 

2008. All of these meetings were public 

meetings, and all entities, both large and 

small, were able to express views on 

this issue. Finally, interested persons 

are invited to submit information on the 

regulatory and informational impacts of 

this action on small businesses. 

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/ 

AMSv1.0/ams.fetchTemplateData.do?

template=TemplateN&page=Marketing

OrdersSmallBusinessGuide. Any 

questions about the compliance guide 

should be sent to Jay Guerber at the 

previously mentioned address in the 

FOR FURTHER INFORMATION CONTACT

section. 

This rule invites comments on a 

revision to the outgoing quality control 

requirements currently prescribed under 

the almond marketing order. Any 

comments received will be considered 

prior to finalization of this rule. 

After consideration of all relevant 

material presented, including the 

Board’s recommendation, and other 

information, it is found that this interim 

final rule, as hereinafter set forth, will 

tend to effectuate the declared policy of 

the Act. 

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

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect and that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) This rule makes a revision 

to the requirements concerning 

validation contained in the current 

regulations to help ensure that all 

treatment equipment meets a 4-log 

reduction in Salmonella in almonds; (2) 

handlers are aware of this action since 

the Board unanimously recommended 

this revision at a public meeting, and 

interested parties had an opportunity to 

provide input; and (3) this rule provides 

a 60-day comment period and any 

comments received will be considered 

prior to finalization of this rule. 

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. Paragraph (b)(3)(i) in § 981.442 is 

revised to read as follows: 

§ 981.442 Quality control. 

* * * * * 

(b) * * * 

(3) * * * 

(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. 

Validation data prepared by a Boardapproved process authority must be 

submitted to and accepted by the TERP 

for each piece of equipment used to 

treat almonds prior to its use under the 

program. 

* * * * * 

Dated: June 12, 2009. 

Craig Morris, 

Acting Associate Administrator. 

[FR Doc. E9–14281 Filed 6–17–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2009–N–0665] 

Oral Dosage Form New Animal Drugs; 

Toceranib 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of a new animal drug 

application (NADA) filed by Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc. 

The NADA provides for the veterinary 

prescription use of toceranib phosphate 

tablets in dogs for treatment of 

recurrent, cutaneous mast cell tumors. 

DATES: This rule is effective June 18, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc., 

235 East 42d St., New York, NY 10017, 

filed NADA 141–295 that provides for 

veterinary prescription use of 

PALLADIA (toceranib phosphate) 

Tablets in dogs for the treatment of 

Patnaik grade II or III, recurrent, 

cutaneous mast cell tumors with or 

without regional lymph node 

involvement. The NADA is approved as 

of May 22, 2009, and the regulations are 

amended in 21 CFR part 520 to reflect 

the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm.