7678 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

27 Id.

28 Id. at 27465.

to prohibit unauthorized access to the

records and to provide for a record of

the identity of the persons who access

such records and of any modifications

made.27 In addition, assurance must be

provided that a computer-generated

record will be made readily available in

machine-readable media or hard copy to

the Commission or DOJ upon request.

Moreover, records stored on ‘‘machine

readable media must use a format and

coding structure’’ specified in such a

request by the Commission or DOJ.28

The Commission recognizes that the

development of electronic order-routing

systems continues to be in flux. The

Commission intends to continue to

monitor that process with a view toward

providing further guidance by advisory

or rule in the future. Among other

things, the Commission will evaluate

the manner in which electronic orderrouting systems may interface with

other audit trail recordkeeping practices

in place at an exchange.

IV. Conclusion

To the extent that a customer order is

prepared and transmitted to and

reported from an exchange trading pit

by an electronic order-routing system, or

a customer order is prepared by an

electronic off-floor order management

system, and the standards set forth

below are satisfied, then the ‘‘written’’

record requirements of Commission

Regulation 1.35(a–1)(1), (a–1)(2)(i), (a–

1)(4), and/or (d) will be deemed

satisfied by the electronic record

generated by the system. Specifically,

such electronic records must:

(1) Include the customer order

information required under Commission

Regulation 1.35.(a–1)(1), (2)(i), (a–1)(4)

and/or 1.35(d);

(2) Include any modification,

including any change and/or

cancellation, that is made to an order

and indicate the time the modification

is recorded in the system;

(3) Record all Commission-required

and other order-related times, including

order entry and exit times, and the time

of any modification made to a customer

order, including any change and/or

cancellation, to the highest level of

precision achievable by the operating

system, but at least to the second. The

times captured must not use a clock that

can be modified by the person entering

the order;

(4) Be kept in hard copy and/or

allowable hard copy substitution media,

as provided under Commission

Regulation 1.31. The stored records

shall be open to inspection by the

Commission or DOJ as required under

Commission Regulation 1.31 and be

made readily available to the

Commission or DOJ in machinereadable media or hard copy upon

request. Records stored on machinereadable media must use a format and

coding structure specified in the

Commission request. To the extent that

records temporarily are stored in

erasable form, appropriate security

measures must be implemented by the

system operator to prohibit any

unauthorized access to the records and

to maintain an accurate record of when

and by whom records are accessed or

modified.

Issued in Washington, DC on February 12,

1997.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 97–4004 Filed 2–19–97; 8:45 am]

BILLING CODE 6351–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 96F–0184]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption; Sulphopropyl Cellulose

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

a change in the level of reactants for

sulphopropyl cellulose ion-exchange

resin for the recovery and purification of

proteins for food use. This action is in

response to a petition filed by Life

Technologies, Inc.

DATES: Effective February 19, 1997;

written objections and requests for a

hearing by March 21, 1997.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Andrew D. Laumbach, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3071.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 3, 1996 (61 FR 34852), FDA

announced that a food additive petition

(FAP 6A4500) had been filed by Life

Technologies, Inc., 8400 Helgerman Ct.,

Gaithersburg MD 20874. The petition

proposed to amend the food additive

regulations in § 173.25 (21 CFR 173.25)

to provide for a change in the level of

the reactants for sulphopropyl cellulose

ion-exchange resin for the recovery and

purification of proteins for food use.

The amendment proposed that the

amount of epichlorohydrin plus

propylene oxide employed does not

exceed 250 percent by weight of the

starting quantity of cellulose. The

current regulation provides that the

amount of epichlorohydrin plus

propylene oxide employed does not

exceed 61 percent by weight of the

starting quantity of cellulose.

In the Federal Register of April 22,

1991 (56 FR 16266), FDA published a

final rule that amended the regulation

under § 173.25 to provide for the use of

the ion-exchange resin and the starting

materials used to manufacture the

additive. The amendment to the

regulation was based upon the

information provided in FAP 6A3905.

In the final rule of April 22, 1991, the

agency stated that while the ionexchange resin has not been shown to

cause cancer, it may contain small

amounts of the starting materials

epichlorohydrin (ECH) and propylene

oxide (PO) as byproducts of its

production. Because the chemicals ECH

and PO have been shown to cause

cancer in test animals, the agency

conducted a quantitative risk

assessment procedure to calculate the

risk from the use of ECH and PO. Based

on the results of the risk assessment, the

agency concluded in the final rule of

April 22, 1991, that there was a

reasonable certainty of no harm from

exposure to ECH and PO that might

result from the proposed use of the

additive.

Recently, the agency was advised that

the levels of the starting materials for

the resin, ECH and PO, that are listed

under § 173.25(a)(20) need to be

amended. The petitioner discovered that

the information in FAP 6A3905 that was

used to calculate the levels of ECH and

PO in the listings for the regulation

contained errors that led to an

underestimation of the actual levels of

ECH and PO used in the production of

the resin. A new petition (FAP 6A4500)

was submitted to correct the regulation

by listing the actual ratios of the starting

materials ECH and PO that are currently

being used in the manufacture of the

ion-exchange resin.

The agency has reviewed the

information in both petitions 6A3905

and 6A4500, and it has determined that
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7679

the levels of ECH and PO set out in

current § 173.25(a)(20) are in error

because those levels do not reflect the

levels presently used by industry to

manufacture the resin. The information

in the present petition establishes that

the manufacturing process and the resin

composition do not differ from the

process and resin composition

evaluated in the original petition.

Because the composition of the resin is

unchanged, the exposure to the residues

of ECH and PO remains unchanged.

Therefore, the agency concludes that the

agency’s safety evaluation conducted for

the original petition (FAP 6A3905)

supports the safety of the amendment to

§ 173.25 proposed by FAP 6A4500.

Accordingly, the agency concludes that

a recalculation of a risk assessment

performed for the original petition (FAP

6A3905) is not necessary to support this

action.

Thus, FDA has evaluated the data in

the petition and other relevant material.

Based on this information, the agency

concludes that: (1) The proposed use of

the additive is safe; (2) the additive will

achieve its intended technical effect;

and that therefore, (3) the regulations in

§ 173.25 should be amended as set forth

below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has determined under 21

CFR 25.24(a)(9) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Any person who will be adversely

affected by this regulation may at any

time on or before March 21, 1997, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 173

Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 173 is

amended as follows:

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: Secs. 201, 402, 409 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348).

2. Section 173.25 is amended by

revising paragraph (a)(20) to read as

follows:

§ 173.25 Ion-exchange resins.

* * * * *

(a) * * *

(20) Regenerated cellulose, crosslinked and alkylated with

epichlorohydrin and propylene oxide,

then sulfonated whereby the amount of

epichlorohydrin plus propylene oxide

employed does not exceed 250 percent

by weight of the starting quantity of

cellulose.

* * * * *

Dated: February 11, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4082 Filed 2–19–97; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300453; FRL–5588–1]

RIN 2070–AB78

Zinc Phosphide; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

phosphine resulting from the use of the

rodenticide zinc phosphide in or on the

raw agricultural commodities timothy

(seed, forage, hay), alfalfa (forage, hay),

and clover (forage, hay) in connection

with EPA’s granting of an emergency

exemption to the state of Washington

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of zinc phosphide

on timothy or timothy-alfalfa, clover

stands. This regulation establishes

maximum permissible levels for

residues of phosphine in these foods

pursuant to section 408(l)(6) of the

Federal Food, Drug and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerances

will expire on April 15, 1998.

DATES: This regulation is effective

February 20, 1997. The entries in the

table expire on April 15, 1998.

Objections and requests for hearings

must be received by EPA on or before

April 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300453],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Room M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300453], must also be submitted to:

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person, bring a copy of objections and

hearing requests to: Crystal Mall #2,

Room 1132, 1921 Jefferson Davis

Highway, Arlington, VA.