Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12159

§ 58.2532 Test methods.

All required tests shall be performed

in accordance with DA Instruction No.

918–RL, ‘‘Instruction for Resident

Grading Quality Control Service

Programs and Laboratory Analysis,’’

Dairy Grading Branch, Dairy Division,

Agricultural Marketing Service, U.S.

Department of Agriculture, Washington,

DC 20090–6456; the latest revision of

‘‘Official Methods of Analysis of the

Association of Official Analytical

Chemists’’; or the latest edition of

‘‘Standard Methods for the Examination

of Dairy Products’’, available from the

American Public Health Association,

1015 Fifteenth Street NW., Washington,

DC 20005.

Explanation of Terms

§ 58.2537 Explanation of terms.

(a) With respect to flavor:

(1) Slight. Detected only upon critical

examination.

(2) Definite. Not intense but

detectable.

(3) Bitter. Distasteful, similar to the

taste of quinine.

(4) Chalky. A tactual type of flavor

lacking in characteristic milk flavor.

(5) Cooked. Similar to a custard flavor

and imparts a smooth aftertaste.

(6) Feed. Feed flavors (such as alfalfa,

sweetclover, silage, or similar feed) in

milk carried through into the nonfat dry

milk.

(7) Flat. Insipid, practically devoid of

any characteristic reconstituted nonfat

dry milk flavor.

(8) Oxidized. A flavor resembling

cardboard and sometimes referred to as

‘‘cappy’’ or ‘‘tallowy’’.

(9) Scorched. A more intensified

flavor than ‘‘cooked’’ and imparts a

burnt aftertaste.

(10) Storage. Lacking in freshness and

imparting a ‘‘stale’’ aftertaste.

(11) Utensil. A flavor that is

suggestive of improper or inadequate

washing and sanitation of milking

machines, utensils, or manufacturing

equipment.

(b) With respect to physical

appearance:

(1) Practically free. Present only upon

very critical examination.

(2) Reasonably free. Present only

upon critical examination.

(3) Slight pressure. Only sufficient

pressure to disintegrate the lumps

readily.

(4) Moderate pressure. Only sufficient

pressure to disintegrate the lumps

easily.

(5) Grainy. Minute particles of

undissolved powder appearing in a thin

film on the surface of a glass or tumbler.

(6) Lumpy. Loss of powdery

consistency but not caked into hard

chunks.

(7) Natural color. A color that is white

to light cream.

(8) Unnatural color. A color that is

more intense than light cream and is

brownish, dull, or grey-like.

(9) Visible dark particles. The

presence of scorched or discolored

specks.

Supplement to U.S. Standards for

Grades of Nonfat Dry Milk (Spray

Process): U.S. Heat Treatment

Classification

§ 58.2538 Basis for obtaining heat

treatment classification.

Heat treatment classification is not a

U.S. grade requirement except in cases

when the higher solubility index

specified for U.S. High-heat product is

permitted. In all other instances,

product submitted for USDA grading

may be analyzed for heat treatment

classification upon request and the

results shown on the grading certificate.

Heat treatment classification will be

made available only upon a product

graded by USDA.

§ 58.2339 Nomenclature of U.S. Heat

Treatment Classification.

The nomenclature of U.S. Heat

Treatment Classification is as follows:

(a) U.S. High-heat.

(b) U.S. Medium-heat.

(c) U.S. Low-heat.

§ 58.2540 Basis for determination of U.S.

Heat Treatment Classification.

The whey protein nitrogen test shall

be used in determining the heat

treatment classification as follows:

(a) U.S. High-heat. The finished

product shall not exceed 1.50 mg.

undenatured whey protein nitrogen per

gram of nonfat dry milk.

(b) U.S. Medium-heat. The finished

product shall exceed 1.50 mg.

undenatured whey protein nitrogen per

gram of nonfat dry milk and shall be

less than 6.00 mg. undenatured whey

protein nitrogen per gram of nonfat dry

milk.

(c) U.S. Low-heat. The finished

product shall be not less than 6.00 mg.

undenatured whey protein nitrogen per

gram of nonfat dry milk.

§ 58.2541 Test method; whey protein

nitrogen.

The whey protein nitrogen test shall

be performed in accordance with DA

Instruction 918–RL, ‘‘Instruction for

Resident Grading Quality Control

Service Programs and Laboratory

Analysis,’’ Dairy Grading Branch, Dairy

Division, Agricultural Marketing

Service, U. S. Department of

Agriculture, Washington, DC 20090–

6456, or the latest edition of ‘‘Standard

Methods for the Examination of Dairy

Products’’, available from the American

Public Health Association, 1015

Fifteenth Street, NW., Washington, DC

20005.

Dated: February 24, 1995.

Kenneth C. Clayton,

Acting Administrator.

[FR Doc. 95–5293 Filed 3–3–95; 8:45 am]

BILLING CODE 3410–02–P

Animal and Plant Health Inspection

Service

9 CFR Parts 102, 104, 105, and 116

[Docket No. 93–072–1]

Viruses, Serums, Toxins, and

Analogous Products; Licenses,

Inspections, Records, and Reports

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations under the Virus-SerumToxin Act to clarify certain provisions

concerning licenses, inspections,

records, and reports. The effect of the

rule is to ensure that licensees are aware

of the fact that licenses are issued on the

condition that the licensee permit

inspection of establishments, products,

and records, and that a licensee must

have at least one product license in

order to maintain a valid establishment

license. Failure to permit inspection

would make the license subject to

suspension or revocation. We are also

proposing amendments concerning the

content of records and reports and their

availability for inspection. The

proposed rule is necessary to clarify and

simplify certain provisions of the

regulations.

DATES: Consideration will be given only

to comments received on or before May

5, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 93–072–1, Animal and Plant

Health Inspection Service, Regulatory

Analysis and Development, Program

and Policy Development, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comments

refer to Docket No. 93–072–1.

Comments received may be inspected at

USDA, room 1141, South Building, 14th

Street and Independence Avenue, SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to
12160 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

inspect comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT:

Dr. Anne Goodman, Chief Staff

Microbiologist, Veterinary Biologics,

BBEP, APHIS, USDA, 4700 River Road

Unit 148, Riverdale, MD 20737–1237.

301–734–8245.

SUPPLEMENTARY INFORMATION: The VirusSerum-Toxin Act of 1913 (21 U.S.C.

151–159), as amended, is intended to

ensure that veterinary biological

products shipped in or from the United

States are not worthless, contaminated,

dangerous, or harmful. To achieve that

purpose, the Act requires that such

products be prepared in compliance

with USDA regulations at an

establishment holding an unsuspended

and unrevoked USDA establishment

license. No such products may be

imported into the United States without

a permit issued by the Administrator.

Provisions regarding veterinary

biological product licenses, license

suspensions, and inspections appear in

the regulations. See for example, 9 CFR

Parts 102, 105, and 116.

The regulations currently provide in

§ 102.4(f) that when a licensee holding

an establishment license no longer

holds an unexpired, unsuspended, or

unrevoked product license authorizing

preparation of a product in the licensed

establishment, the establishment license

shall be submitted to the Administrator

for termination.

Pursuant to § 102.2 of the regulations,

licensees producing biological products

in the United States are required to hold

at least one unexpired, unsuspended,

and unrevoked product license in

addition to an establishment license.

Therefore, and establishment license

without a product license would not be

valid. Section 102.2 would be amended

to make this clear.

Section 102.4 would also be amended

by revising paragraph (f) and by adding

new paragraph (g). Paragraph (f) would

be revised to provide that an

establishment license is not valid unless

the licensee also holds a product

license, or is in the process of obtaining

one. This would include activities such

as requesting or filing a product license

application or being involved in the

development of a product. Paragraph (g)

would provide that licenses for

establishments where biological

products are prepared shall be issued on

condition that the licensee shall permit

the inspection by USDA inspectors of

such establishments and of products

prepared in these establishments.

Failure to permit such inspection could

result in license suspension or

revocation. This proposed change

simply reflects the language in § 157 of

the Virus-Serum-Toxin Act.

In § 104.6(b), editorial changes would

be made to reflect organizational

changes within the Animal and Plant

Health Inspection Service. The words

‘‘Veterinary Services’’ would be

removed and the words ‘‘Animal and

Plant Health Inspection Service’’ would

be added in their place.

Amendments would also be made to

two sections of part 105 of the

regulations which deal with suspension,

revocation, or termination of biological

product licenses or permits. In § 105.1,

current paragraphs (a)(4) and (5) would

be redesignated paragraphs (a)(5) and

(6). New § 105.1(a)(4) would be added to

assure that licensees, permittees, or

foreign manufacturers of products that

are imported under permit, maintain

and make available for inspection all

records relevant to the development and

preparation of a product. Records and

reports would be required to be

complete and accurate.

Otherwise a license or permit could

be subject to suspension or revocation

under § 105.1. This proposed

amendment to clarify the regulations is

necessary because of recent incidence of

noncompliance and refusal by licensees

or permittees to produce requested

records and reports. Since

recordkeeping is already required under

current § 116.8, no new paperwork

burden would be imposed.

The second amendment which would

be made in Part 105 is to § 105.4

concerning termination of licenses for

inactivity. Proposed § 105.4(a) would

specify that a product license or a

permit would be terminated for

inactivity unless intent to resume

activity is demonstrated. Proposed

§ 105.4(b) would also specify that

certain records be completed and

retained in accordance with provisions

in § 116.8. The proposed amendment

would help to make the section clearer

and easier to administer.

The proposed rule would also amend

several sections of Part 116 which deal

with records and reports. First § 116.1

would be amended to provide that

detailed records and reports concerning

biological products must be maintained

at the establishment in which the

products are produced, unless otherwise

authorized (See proposed § 116.1(c)).

This proposed change is necessary

because of problems which have arisen

during inspections involving records

which were not available at the

producing establishment. Since such

records and reports are already required

under current §§ 116.5 and 116.8, no

new reporting or recordkeeping burden

would be imposed.

Proposed § 116.1(b) would also be

added to provide for appropriate records

at the permittee’s place of business.

Proposed § 116.1(c) would be added to

provide for maintenance of records at an

alternate location. Such an alternate

location would have to be confirmed by

filing an addendum to the plot plan

legend. The proposed amendment

would provide for archiving of records,

maintenance of distribution records,

and compilation of consumer reports in

off-premise facilities and other

locations. Such archiving of records and

reports should not result in paperwork

burden that is greater than that already

required under current §§ 116.5 and

116.8.

Section 116.5 would be amended to

clarify that producers and importers of

biological products may be required to

submit reports containing information

related to production activities or the

purity, safety, potency, and efficacy of a

product. The proposed amendment

would clarify that APHIS be notified

when a consumer report raises a

question regarding purity, safety,

potency, and efficacy of a product or a

product is found to be unsatisfactory, or

prepared, tested, or distributed in

violation of the act or regulations.

Again, the amendment is necessary to

clarify for licensees, permittees, and

foreign manufacturers the type of

information that must be provided to

APHIS. Since product purity, safety,

potency, and efficacy remain the

responsibility of licensees and

permittees, no new paperwork burden

would be imposed by these

amendments over what is required in

current part 116.

Section 116.7 would be amended to

state that test summaries prepared from

reports must be submitted to APHIS on

Form 2008 or its equivalent prior to

serial or subserial release.

Finally § 116.8, which deals with

records and their retention, would be

amended by including permittees in the

requirement that records concerning

biological products (other than

disposition records) be completed prior

to product marketing or export. In

addition, permittees would be required

to retain all records at a designated

establishment or place of business for a

specified period of time after the

expiration date of the product. Since the

permittee is normally a licensee or a

representative of a foreign manufacturer,

who already has recordkeeping

requirements under current § 116.8, no

new recordkeeping requirements would

be imposed by this amendment.
Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12161

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be not

significant for purposes of Executive

order 12866, and therefore, has not been

reviewed by the Office of Management

and Budget.

The proposed rule would amend the

regulations in 9 CFR parts 102, 104, 105,

and 116 to clarify existing provisions

concerning licenses, inspections,

records, and reports. Licenses are issued

on condition that the licensee permit

inspection of establishments, products,

and records. The proposed rule would

provide that the failure to permit such

inspection would make the license

subject to suspension or revocation. In

order to hold a valid establishment

license, licenses are required to have at

least one unexpired, unsuspended, and

unrevoked product license. Otherwise,

the establishment license would be

invalid. We are also proposing

amendments concerning the content of

records and reports and the availability

of their inspection.

The proposed rule would make clear

and unambiguous certain regulatory

provisions. No new requirements are

added in the proposed rule. Therefore,

no adverse economic impact would

result from the rule.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are in conflict with this

rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.), the information collection or

recordkeeping requirements included in

this proposed rule have been approved

by the Office of Management and

Budget (OMB), and there are no new

requirements. The assigned OMB

control number is 0579–0013.

List of Subjects

9 CFR Part 102

Animal biologics, Reporting and

recordkeeping requirements.

9 CFR Part 104

Animal biologics, Imports, Reporting

and recordkeeping requirements,

Transportation.

9 CFR Part 105

Animal biologics.

9 CFR Part 116

Animal biologics, Reporting and

recordkeeping requirements.

Accordingly, 9 CFR parts 102, 104,

105, and 116 would be revised as

follows:

PART 102—LICENSES FOR

BIOLOGICAL PRODUCTS

1. The authority citation for part 102

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

2. In § 102.2, the introductory

paragraph would be designated as

paragraph (a) and a new paragraph (b)

would be added to read as follows:

§ 102.2 Licenses required.

* * * * *

(b) An applicant who applies for an

establishment license must also apply

for at least one product license. An

establishment license will not be issued

without a license authorizing the

production of a biological product in the

establishment.

3. In § 102.4, paragraph (f) would be

revised, paragraphs (g) and (h) would be

redesignated as paragraphs (h) and (i),

respectively, and new paragraph (g)

would be added to read as follows:

§ 102.4 U.S. Veterinary Biologics

Establishment License.

* * * * *

(f) When a licensee no longer holds at

least one unexpired, unsuspended, or

unrevoked product license authorizing

the preparation of a biological product,

or is in the process of obtaining a

product license, the establishment

license shall no longer be valid and

shall be returned to the Administrator.

In the case where an establishment

license expires or is suspended or

revoked, any product license

authorizing preparation of a product at

such establishment shall be invalid

indefinitely or for as long as the

suspension is in effect.

(g) Any license issued under this Part

to establishments in which biological

products are prepared shall be issued on

condition that the licensee permit the

inspection of such establishments,

products, product preparation, and all

relevant records as provided in Part 115.

Failure to permit inspection may result

in the license being suspended or

revoked.

* * * * *

PART 104—PERMITS FOR

BIOLOGICAL PRODUCTS

4. The authority citation for part 104

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

§ 104.6 [Amended]

5. In § 104.6, paragraph (b), the words

‘‘Veterinary Services’’ would be

removed and the words ‘‘Animal and

Plant Health Inspection Service’’ would

be added in their place.

6. In 9 CFR part 105, the heading for

the part would be revised to read as

follows:

PART 105—SUSPENSION,

REVOCATION, OR TERMINATION OF

BIOLOGICAL LICENSES OR PERMITS

7. The authority citation for part 105

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

8. In § 105.1, paragraphs (a)(4) and

(a)(5) would be redesignated paragraphs

(a)(5) and (a)(6), new paragraph (a)(4)

would be added, and redesignated

paragraph (a)(5) would be revised to

read as follows:

§ 105.1 Suspension or revocation.

* * * * *

(a) * * *

(4) The licensee, permittee, or the

foreign manufacturer has failed to

maintain and make available for

inspection records in connection with

the development and preparation of

product, has failed to provide complete

and accurate information when

requested, or has failed to provide

complete and accurate information in

the Outline of Production or in reports

and records;

(5) The licensee or permittee has

violated or failed to comply with any

provision of the Virus-Serum-Toxin Act

or the regulations in this subchapter;

* * * * *

9. Section 105.4 would be revised to

read as follows:
12162 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

§ 105.4 Termination of licenses and

permits for inactivity.

(a) If a biological product has not been

prepared by a licensee, or imported by

a permittee for a period of five years or

more, the Administrator may require the

licensee to show intent to resume

production, or the permittee to show

intent to resume importation, within six

months of notification. If the licensee

does not resume preparation, or the

permittee does not resume importation,

within six months of notification, or

within a mutually agreeable period, the

product license, or permit, may be

terminated by the Administrator.

(b) When a license or permit is

terminated, the licensee or permittee

shall continue to be subject to

applicable records provisions of § 116.8.

10. In 9 CFR part 116, the heading for

the part would be revised to read as

follows:

PART 116—RECORDS AND REPORTS

11. The authority citation for part 116

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

12. In § 116.1, paragraphs (a), (b) and

(c) would be redesignated as paragraphs

(a)(1), (a)(2), and (a)(3), respectively;

redesignated paragraph (a)(1) would be

revised; the introductory paragraph

would be designated as paragraph (a)

and would be revised; and new

paragraphs (b) and (c) would be added

to read as follows:

§ 116.1 Applicability and general

considerations.

(a) Each licensee, permittee, and

foreign manufacturer of biological

products imported into the United

States shall maintain, at the licensed or

foreign establishment in which the

products are prepared, detailed records

of information necessary to give a

complete accounting of all the activities

within such establishment. Such

records shall include, but shall not be

limited to, the items enumerated in this

part.

(1) Records shall be made

concurrently with the performance of

successive steps in the development and

preparation of biological products,

including new products under

development. Such records shall

include the date and where critical, the

time that each essential step was taken,

the identity and quantity of ingredients

added or removed at each step, and any

gain or loss of product from the

beginning to the end of product

preparation.

* * * * *

(b) In the case of imported products,

each permittee shall maintain at the

permittee’s place of business detailed

and accurate records that are relevant to

each imported product and that include,

but are not limited to, importation

documents, sampling records, tests

summaries, shipping records, and

inventory and disposition records as

required in § 116.2.

(c) When authorized by the

Administrator, the licensee, permittee,

or foreign manufacturer may maintain

and retain records required under part

116 at an alternative location. Such

authorization shall be confirmed by the

filing of an addendum to the plot plan

legend. The addendum shall list the

location of the records and the

condition of their storage and shall

permit the inspection of the records by

APHIS inspectors, or foreign inspectors

acting on behalf of APHIS.

(Approved by the Office of Management and

Budget under control number 0579–0013)

§§ 116.2, 116.3, 116.4, and 116.6

[Amended]

13. At the end of §§ 116.2, 116.3,

116.4, and 116.6, the reference to OMB

control number ‘‘0579–0059’’ would be

removed and the number ‘‘0579–0013’’

would be added in its place.

14. Section 116.5 would be revised to

read as follows:

§ 116.5 Reports.

(a) When required by the

Administrator, reports containing

accurate and complete information

concerning biological products,

including but not limited to, product

development and preparation, consumer

reports, and market suspensions and

recalls, shall be prepared and submitted

to the Animal and Plant Health

Inspection Service by the licensee,

permittee, or foreign manufacturer

whose products are being imported or

offered for importation. Unless

otherwise authorized by the

Administrator, records necessary to

make such reports shall be maintained

in each establishment.

(b) If, at any time, consumer reports

concerning the use of products raise

questions regarding purity, safety,

potency, or efficacy of the products; or

a biological product appears to be

unsatisfactory or is found to have been

prepared, tested, or distributed in

violation of the Virus-Serum-Toxin Act

or the regulations; the licensee,

permittee, or foreign manufacturer shall

immediately report the circumstances

and the action taken, if any, to the

Animal and Plant Health Inspection

Service.

(Approved by the Office of Management and

Budget under control number 0579–0013)

15. In § 116.7, the second sentence

would be revised to read as follows:

§ 116.7 Test records.

* * * Summaries of such tests shall

be prepared from such records and

submitted to the Animal and Plant

Health Inspection Service using APHIS

Form 2008 or an acceptable equivalent

form prior to release of the serial or

subserial. * * *

* * * * *

16. Section 116.8 would be revised to

read as follows:

§ 116.8 Completion and retention of

records.

All records (other than disposition

records) required by this part shall be

completed by the licensee, permittee, or

foreign manufacturer before any portion

of a serial of any product may be

marketed in the United States or

exported. All records shall be retained

at the licensed or foreign establishment

or permittee’s place of business for a

period of two years after the expiration

date of a product, or for such longer

period as may be required by the

Administrator.

(Approved by the Office of Management and

Budget under control number 0579–0013)

Done in Washington, DC, this 28th day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5406 Filed 3–3–95; 8:45 am]

BILLING CODE 3410–34–M

9 CFR Parts 102 and 114

[Docket No. 93–136–1]

Viruses, Serums, Toxins, and

Analogous Products; State-Federal

Licensure of Veterinary Biologics

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations concerning State-Federal

licensing of veterinary biological

products. The effect of the amendment

would be that a Federally licensed

establishment would not be allowed to

produce the same veterinary biological

product under both a State and Federal

product license. Autogenous biologics

would not be subject to the same

requirement, in that a Federally licensed

establishment could hold both State and

Federal product licenses for autogenous

biologics, but must choose to produce

each specific serial of such biologic