This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

5327 

Vol. 72, No. 24 

Tuesday, February 6, 2007 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 966 

[Docket No. AMS–FV–06–0208; FV07–966– 

1 IFR] 

Tomatoes Grown in Florida; Change in 

Handling Requirements 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: This rule changes the 

handling requirements currently 

prescribed under the Florida Tomato 

marketing order (order). The order 

regulates the handling of tomatoes 

grown in Florida, and is administered 

locally by the Florida Tomato 

Committee (Committee). This rule limits 

the use of inverted lids on tomato 

containers to the handler whose 

information initially appeared on the 

lid. This rule helps ensure that lids do 

not contain the information for more 

than one active handler and aids in 

maintaining the positive identification 

and traceability of Florida tomatoes. 

DATES: Effective February 7, 2007; 

comments received by April 9, 2007 

will be considered prior to issuance of 

a final rule. 

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; E-mail 

moab.docketclerk@usda.gov; or Internet: 

http://www.regulations.gov. All 

comments should reference the docket 

number and the date and page number 

of this issue of the Federal Register and 

will be made available for public 

inspection in the Office of the Docket 

Clerk during regular business hours, or 

can be viewed at: http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

William Pimental, Marketing Specialist; 

or Christian Nissen, Regional Manager, 

Southeast Marketing Field Office, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA; telephone: (863) 324– 

3375, Fax: (863) 325–8793, or E-mail: 

William.Pimental@usda.gov or 

Christian.Nissen@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 rule 

is issued under Marketing Agreement 

No. 125 and Order No. 966, both as 

amended (7 CFR part 966), regulating 

the handling of tomatoes grown in 

Florida, 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 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. A 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 petition, 

provided an action is filed not later than 

20 days after the date of the entry of the 

ruling. 

This rule changes the handling 

requirements currently prescribed under 

the order. This rule limits the use of 

inverted lids on tomato containers to the 

handler whose information initially 

appeared on the lid. This rule helps 

ensure that lids do not contain the 

information for more than one active 

handler and aids in maintaining the 

positive identification and traceability 

of Florida tomatoes. This action was 

unanimously recommended by the 

Committee at a meeting on October 4, 

2006. 

Section 966.52 of the order provides 

the authority to establish pack and 

container requirements for tomatoes 

grown under the order. This includes 

fixing the size, weight, capacity, 

dimensions, markings, or pack of the 

container or containers which may be 

used in the handling of tomatoes. 

Section 966.323 of the order’s 

administrative rules prescribes the 

handling regulations for Florida 

tomatoes. Section 966.323(a)(3) 

delineates the requisite container 

requirements for weight, markings, and 

appearance. The section specifies, in 

part, that each container or lid must 

show the name and address of the 

registered handler. 

The majority of Florida tomatoes are 

packed in containers that have a 

separate lid. Most lids are preprinted 

with the handler’s name and address. In 

addition, most lids can be inverted by 

reversing the lid so the blank side is on 

the outside, and the preprinted 

information is flipped to the underside 

of the lid. This is done so new 

information can be printed on the lid. 

This rule amends § 966.323(a)(3) by 

limiting the use of inverted lids on 

tomato containers to the handler whose 

information first appeared on the lid. 

Inverted lids have been used in 

minimal quantities in past seasons, 

usually when a tomato packing 

operation was purchased by another 

entity. Any containers included in the 

purchase could be used by the 

purchasing handler by inverting the lids 

so the purchaser’s information could be 

affixed on the clean side. Usually there 

were not many containers remaining, so 


rmajette on PROD1PC67 with RULES
5328 Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Rules and Regulations 

the containers requiring inverted lids 

were fairly limited in quantity. 

Recently, container sales companies 

have started offering their container 

overruns at discounted prices to tomato 

handlers. These containers usually have 

preprinted handler and product 

information on the lids. The Committee 

is concerned this could significantly 

increase the number of inverted lids 

being used by the industry and could 

pose problems with the positive 

identification and traceability of 

tomatoes. 

In their discussion of this issue, the 

committee agreed the ability to 

positively identify product is a necessity 

in today’s marketplace. The Committee 

expressed concern that the practice of 

inverting lids could result in 

misidentification and confusion in cases 

where tomatoes need to be traced back 

to their origin. The Committee 

recognized that in the past, most of the 

containers being used with an inverted 

lid were associated with a handler 

purchasing another operation. 

Consequently, the original owner of the 

lid was no longer in business, and the 

container was only printed with the 

information for one active handler. 

This would not be the case with 

handlers using overrun containers. The 

overrun containers being made available 

are containers produced in excess of 

orders, with the majority preprinted 

with handler information. Therefore, 

once inverted, the lids on the overrun 

containers would be printed with the 

information for two active handlers. The 

Committee is concerned that having 

multiple handler information on a 

container, even with the lid inverted, 

could pose problems when trying to 

track tomatoes back to the original 

handler. 

The Committee believes it is of 

critical importance that Florida 

tomatoes can be traced from the farm to 

the end-user. Proper handler 

identification on a container is an 

important part of this traceability. 

Allowing the use of containers with an 

active registered handler’s information 

on the exterior of the lid and another on 

the interior could allow for 

misidentification and confusion in 

product identification. The Committee 

believes by limiting the use of inverted 

lids to the handler whose name 

originally appeared on the lid, positive 

identification and traceability will be 

better maintained. 

In addition, in cases related to 

marketing order compliance, it is also 

important to be able to identify the 

original source of tomatoes. Allowing 

the use of inverted lids could result in 

the intentional misrepresentation of the 

origin of the tomatoes. The box lids 

could be reinverted to display the 

handler information originally printed 

on the box without that handler’s 

knowledge. Limiting the use of inverted 

lids on tomato containers by anyone 

other than the handler whose 

information first appeared on the lid 

will help alleviate any misidentification 

or uncertainty in product identification. 

Section 8e of the Act provides that 

when certain domestically produced 

commodities, including tomatoes, are 

regulated under a Federal marketing 

order, imports of that commodity must 

meet the same or comparable grade, 

size, quality, and maturity requirements. 

As this rule changes the container 

requirements under the domestic 

handling regulations, no corresponding 

change to the import regulations are 

required. 

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 action 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 100 

producers of tomatoes in the production 

area and approximately 70 handlers 

subject to regulation under the 

marketing order. Small agricultural 

producers are defined by the Small 

Business Administration (SBA) as those 

having annual receipts less than 

$750,000, and small agricultural service 

firms are defined as those whose annual 

receipts are less than $6,500,000 (13 

CFR 121.201). 

Based on industry and Committee 

data, the average annual price for fresh 

Florida tomatoes during the 2005–06 

season was approximately $10.27 per 

25-pound container, and fresh 

shipments totaled 47,880,303 25-pound 

cartons of tomatoes. Committee data 

indicates approximately 27 percent of 

the handlers handle 95 percent of the 

total volume shipped outside the 

regulated area. Based on the average 

price, about 75 percent of handlers 

could be considered small businesses 

under SBA’s definition. In addition, 

based on production, grower prices as 

reported by the National Agricultural 

Statistics Service, and the total number 

of Florida tomato growers, the average 

annual grower revenue is below 

$750,000. Thus, the majority of handlers 

and producers of Florida tomatoes may 

be classified as small entities. 

This rule changes the handling 

requirements currently prescribed under 

the order. This rule limits the use of 

inverted lids on tomato containers to the 

handler whose information initially 

appeared on the lid. This rule helps 

ensure that lids do not contain the 

information for more than one active 

handler and aids in maintaining the 

positive identification and traceability 

of Florida tomatoes. This rule revises 

§ 966.323(a)(3), which specifies the 

requisite container requirements. 

Authority for this action is provided in 

§ 966.52 of the order. The Committee 

unanimously recommended this change 

at a meeting held on October 4, 2006. 

At the meeting, the Committee 

discussed the impact of this change on 

handlers in terms of cost. This rule 

could result in a slight increase in cost 

for handlers that were considering 

purchasing the container overruns. 

However, Committee members stated 

that plain containers are readily 

available on the market at reasonable 

prices. Consequently, the difference in 

cost between a discounted overrun 

container and a plain blank container 

should be minimal. 

In addition, last season the industry 

packed more than 47 million cartons of 

tomatoes. The available quantities of 

overrun containers are limited, 

confining the cost benefit to those 

containers available. When compared to 

the total containers needed, the overall 

cost savings associated with using 

overrun cartons would be negligible. 

Also, in previous seasons, overrun 

containers were not available for 

purchase. Therefore, container cost for 

all handlers should be similar to those 

in previous seasons. 

Further, this rule provides the benefit 

of helping to maintain the traceability 

and proper identification of Florida 

tomatoes, which outweighs the minor 

cost savings associated with using 

overrun containers. The costs and 

benefits of this rule are not expected to 

be disproportionately different for small 

or large entities. 

One alternative to this action was to 

allow the use of inverted lids. However, 

Committee members agreed that having 

the information for more than one active 

handler appear on a carton was 

confusing and could make traceability 

and proper identification difficult. 

Therefore, this alternative was rejected. 


rmajette on PROD1PC67 with RULES
Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Rules and Regulations 5329 

This action will not impose any 

additional reporting or recordkeeping 

requirements on either small or large 

tomato 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. 

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. 

In addition, USDA has not identified 

any relevant Federal rules that 

duplicate, overlap or conflict with this 

rule. 

Further, the Committee’s meeting was 

widely publicized throughout the 

Florida tomato industry and all 

interested persons were invited to 

attend the meeting and participate in 

Committee deliberations. Like all 

Committee meetings, the October 4, 

2006, meeting was a public meeting 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/ 

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. 

This rule invites comments on a 

change to the container requirements 

currently prescribed under the Florida 

tomato marketing order. Any comments 

received will be considered prior to 

finalization of this rule. 

After consideration of all relevant 

material presented, including the 

Committee’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) The 2006–07 season has 

begun, and handlers are currently 

packing tomatoes; (2) the Committee 

unanimously recommended this change 

at a public meeting and interested 

parties had an opportunity to provide 

input; (3) handlers are aware of this 

change; and (4) 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 966 

Marketing agreements, Reporting and 

recordkeeping requirements, Tomatoes. 

■ For the reasons set forth in the 

preamble, 7 CFR part 966 is amended as 

follows: 

PART 966—TOMATOES GROWN IN 

FLORIDA 

■ 1. The authority citation for 7 CFR 

part 966 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. Section 966.323 paragraph (a)(3)(ii) 

is revised to read as follows: 

§ 966.323 Handling regulation. 

* * * * * 

(a) * * * 

(3) * * * 

(ii) Each container or lid shall be 

marked to indicate the designated net 

weight and must show the name and 

address of the registered handler (as 

defined in 966.7) in letters at least onefourth (1⁄4) inch high, and such 

containers must be packed at the 

registered handler’s facilities. The use of 

inverted, previously printed container 

lids is limited to the registered handler 

identified by the labels or marks that 

originally appeared on the lid. 

* * * * * 

Dated: February 1, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 07–502 Filed 2–5–07; 8:45 am] 

BILLING CODE 3410–02–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 529 

New Animal Drugs; Hydrogen Peroxide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a new animal drug 

application (NADA) filed by Eka 

Chemicals, Inc. The NADA provides for 

immersion use of hydrogen peroxide 

solution for control of mortality in 

certain freshwater-reared finfish species 

in several life stages due to various 

fungal and bacterial diseases. 

DATES: This rule is effective February 6, 

2007. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. 

SUPPLEMENTARY INFORMATION: Eka 

Chemicals, Inc., 1775 West Oak 

Commons Ct., Marietta, GA 30062– 

2254, filed NADA 141–255 for 35% 

PEROX–AID (hydrogen peroxide) for 

control of mortality in freshwater-reared 

finfish eggs due to saprolegniasis, for 

control of mortality in freshwater-reared 

salmonids due to bacterial gill disease 

associated with Flavobacterium 

branchiophilum, and for control of 

mortality in freshwater-reared coolwater 

finfish and channel catfish due to 

external columnaris disease associated 

with Flavobacterium columnare 

(Flexibacter columnaris). The NADA is 

approved as of January 11, 2007, and the 

regulations are amended in part 529 (21 

CFR part 529) by adding § 529.1150 to 

reflect the approval. The basis of 

approval is discussed in the freedom of 

information summary. 

In addition, Eka Chemicals, Inc., has 

not been previously listed in the animal 

drug regulations as a sponsor of an 

approved application. At this time, 21 

CFR 510.600(c) is being amended to add 

entries for this firm. 

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. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Under section 573(c) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360ccc-2), this approval 

qualifies for 7 years of exclusive 

marketing rights beginning January 11, 

2007, because the new animal drug has 

been declared a designated new animal 

drug by FDA under section 573(a) of the 

act. 

The agency has carefully considered 

the potential environmental effects of 

this action. FDA has concluded that the 

action will not have a significant impact 

on the human environment, and that an 

environmental impact statement is not 


rmajette on PROD1PC67 with RULES