Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations 2113

upper-bound limits of lifetime risk from

exposure to the impurity, even under

worst-case assumptions, is very low, in

the range of less than 3.2 in 1 trillion to

1.5 in 100 billion.

III. Conclusion

FDA has evaluated data in the

petition and other relevant material and

concludes that the proposed use of the

additive in adhesives is safe. Based on

this information, the agency has also

concluded that the additive will have

the intended technical effect. Therefore,

§ 175.105 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 21 CFR

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.

IV. Environmental Impact

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

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

V. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Memorandum from the Chemistry

Review Branch (HFS–247), Center for Food

Safety and Applied Nutrition (CFSAN), FDA,

to the Indirect Additives Branch (HFS–216),

CFSAN, FDA, concerning FAP 4B4435—Dow

Chemical Co.—exposure to the food additive

and its component, propylene oxide, dated

March 1, 1995.

2. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology,’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger and J. K. Marquis, S. Karger, New

York, NY, pp. 24–33, 1985.

3. Dunkelberg, H., ‘‘Carcinogenicity of

Ethylene Oxide and 1,2-Propylene Oxide

Upon Intragastric Administration to Rats,’’

British Journal of Cancer, 46: 924, 1982.

4. Memorandum, ‘‘Report of the

Quantitative Risk Assessment Committee,’’

CFSAN, FDA, dated April 20, 1995.

VI. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before February 26, 1996, 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 175

Adhesives, Food additives, Food

packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 175 is

amended as follows:

PART 175—INDIRECT FOOD

ADDITIVES: ADHESIVES AND

COMPONENTS OF COATINGS

1. The authority citation for 21 CFR

part 175 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 175.105 is amended in

paragraph (c)(5) in the table by

alphabetically adding a new entry under

the headings ‘‘Substances’’ and

‘‘Limitations’’ to read as follows:

§ 175.105 Adhesives.

* * * * *

(c) * * *

(5) * * *

Substances Limitations

* * * * * * *

Glycerol polyoxypropylene triol, minimum average

molecular weight 250 (CAS Reg. No. 25791–96–2).

For use only in the preparation of polyester and polyurethane resins in adhesives.

* * * * * * *

Dated: January 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–1143 Filed 1–24–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 93F–0243]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

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

the safe use of 4,5,6,7-tetrachloro-2-[2-

(4,5,6,7-tetrachloro-2,3-dihydro-1,3-

dioxo-1H-inden-2-yl)-8-quinolinyl]-1Hisoindole-1,3(2H)-dione (C. I. Pigment

Yellow 138), as a colorant for all foodcontact polymers. This action is in

response to a petition filed by BASF

Corp.
2114 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations

DATES: Effective January 25, 1996;

written objections and requests for a

hearing February 26, 1996.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

August 18, 1993 (58 FR 43898), FDA

announced that a food additive petition

(FAP 3B4383) had been filed by BASF

Corp., 8 Campus Dr., Parsippany, NJ

07054. The petition proposed to amend

the food additive regulations in

§ 178.3297 Colorants for polymers (21

CFR 178.3297) to provide for the safe

use of 4,5,6,7-tetrachloro-2-[2-(4,5,6,7-

tetrachloro-2,3-dihydro-1,3-dioxo-1Hinden-2-yl)-8-quinolinyl]-1H-isoindole1,3(2H)-dione (C.I. Pigment Yellow 138,

CAS Reg. No. 30125–47–4), as a colorant

for all food-contact polymers.

In its evaluation of the safety of this

additive, FDA has reviewed the safety of

the additive itself and the chemical

impurities that may be present in the

additive resulting from its

manufacturing process. Although the

additive itself has not been shown to

cause cancer, minute amounts of

carcinogenic polychlorinated dibenzo-pdioxins (PCDD’s) have been detected as

impurities in tetrachlorophthalic

anhydride, one of the reactants used to

produce the additive (C. I. Pigment

Yellow 138). Residual amounts of

reactants and manufacturing aids, such

as PCDD’s, are commonly found as

contaminants in chemical products,

including food additives.

I. Determination of Safety

Under section 409(c)(3)(A) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 348(c)(3)(A)), the socalled ‘‘general safety clause’’ of the

statute, a food additive cannot be

approved for a particular use unless a

fair evaluation of the data available to

FDA establishes that the additive is safe

for that use. FDA’s food additive

regulations (21 CFR 170.3(i)) define safe

as ‘‘a reasonable certainty in the minds

of competent scientists that the

substance is not harmful under the

intended conditions of use.’’

The food additives anticancer or

Delaney clause (section 409(c)(3)(A) of

the act) further provides that no food

additive shall be deemed safe if it is

found to induce cancer when ingested

by man or animal. Importantly,

however, the Delaney clause applies to

the additive itself and not to impurities

in the additive. That is, where an

additive itself has not been shown to

cause cancer, but contains a

carcinogenic impurity, the additive is

properly evaluated under the general

safety clause using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the proposed use of the

additive, Scott v. FDA, 728 F.2d 322

(6th Cir. 1984).

II. Safety of Petitioned Use of The

Additive

FDA estimates that the petitioned use

of the additive, C. I. Pigment Yellow

138, will result in exposure to the

additive of no greater than 1.8 parts per

billion (ppb), which equates to an

estimated daily intake (EDI) of 5.4

micrograms per person per day (μg/p/d)

(Ref. 1). The agency has also calculated

the EDI of the migrating impurities

associated with the colorant under the

most severe conditions of the colorant’s

intended use (phenol,

tetrachlorophthalic anhydride, 8-

aminoquinaldine, and the

monocondensation product) and the

probable concentrations of these

migrants from the colorant’s use in

contact with food. The agency estimated

the potential daily intakes of the four

impurities to be 13, 10, 5.4, and 10

nanograms/p/d, respectively (Ref. 1).

The additive may also contain small

amounts of carcinogenic impurities

(PCDD’s).

FDA does not ordinarily consider

chronic toxicological testing to be

necessary to determine the safety of an

additive whose use will result in such

low exposure levels (Ref. 2), and the

agency has not required such testing

here. However, the agency has reviewed

the available toxicological data from

acute toxicity studies on the additive.

No adverse effects were reported in

these studies.

FDA has evaluated the safety of this

additive under the general safety clause,

considering all available data and using

risk assessment procedures to estimate

the upper-bound limit of risk presented

by the carcinogenic chemicals (PCDD’s)

that may be present as impurities in the

additive. This risk evaluation of PCDD’s

has two aspects: (1) Assessment of the

worst-case exposure to the impurities

from the proposed use of the additive;

and (2) extrapolation of the risk

observed in the animal bioassays to the

conditions of probable exposure to

humans.

A. PCDD’s

FDA has estimated the worst-case

exposure to PCDD’s from the petitioned

use of the additive as discussed below.

Because little is known about the

toxicity of PCDD’s except 2,3,7,8-

tetrachlorodibenzo-p-dioxin (TCDD), the

agency utilized the toxicity equivalency

factor (TEF) method (Ref. 3) to relate the

toxicity of the PCDD’s in terms of an

equivalent amount of toxicologically

well characterized TCDD, and used the

TEF’s adopted by the North Atlantic

Treaty Organization (Ref. 4) (see 59 FR

17384, April 12, 1994). Summing the

equivalent EDI’s for each PCDD present

as an impurity gives the total exposure

to PCDD’s in terms of a total equivalent

EDI for TCDD of 1.4 x 10-4 picogram

(pg)/p/d (Ref. 1).

Using data from a 2-year chronic

toxicity and carcinogenicity study by

Kociba et al. (Ref. 5) on TCDD fed to

rats, the agency estimated the upperbound level of lifetime human risk from

exposure to TCDD toxic equivalents

resulting from the use of C. I. Pigment

Yellow 138 as a food contact colorant

for polymers. The results of the bioassay

on TCDD showed that the material was

carcinogenic for rats under the

conditions of the study in that the test

material caused significantly increased

incidences of hepatocellular carcinomas

and adenomas as well as squamous cell

carcinomas of the lung, hard palate,

nasal turbinates, and tongue. FDA

further concluded that given the paucity

of TCDD bioassay data, the Kociba et al.

bioassay provided the appropriate basis

on which to calculate an estimate of the

upper-bound level of lifetime

carcinogenesis risk from exposure to

TCDD toxic equivalents stemming from

the use of the subject additive (C. I.

Pigment Yellow 138) as a colorant in

food-contact polymers.

The agency used a linear-at-low-dose

extrapolation method from the doses

used in the Kociba et al. bioassay and

the tumor incidence data based upon

the original classification of tumors

found in that study to estimate the

upper-bound risk presented by the very

low levels of TCDD toxic equivalents

encountered under actual conditions of

the use of the additive as colorant in

polymers. This procedure is not likely

to underestimate the actual risk from

very low doses and may in fact

exaggerate it because the extrapolation

models used are designed to estimate

the maximum risk consistent with the

data. In so doing, FDA estimated a

carcinogenic unit risk of 16 × 10-6 for an

intake of 1 pg/kilogram (kg) body

weight/d of TCDD toxic equivalents

(Ref. 6).
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations 2115

As noted, the carcinogenic unit risk

assessed above by FDA was based on

the original tumor incidence data from

the Kociba bioassay (Ref. 5). Following

FDA’s risk assessment discussed above,

however, a group of pathologists, the

Pathology Working Group (PWG),

reanalyzed the slides of the liver tumors

observed in the Kociba bioassay using

the National Toxicology Program’s 1986

classification system for liver tumors

(Ref. 7). FDA has reviewed the results of

this reanalysis and agrees with the

classification of the tumors made by

PWG. Using the results of this revised

reading of the Kociba study slides, FDA

estimates a carcinogenic unit risk of 9 ×

10-6 for an intake of 1 pg TCDD

equivalents/kg body weight/d (Ref. 8).

Using this carcinogenic unit risk and an

upper-bound total exposure to PCDD’s

present in the additive in terms of a

total equivalent EDI for TCDD of 1.4 ×

10-4 pg/p/d, FDA estimates that the

upper-bound limit of risk of cancer

would be 2.1 × 10-11 from the proposed

use of the subject additive (Ref. 9).

Because of the numerous conservative

assumptions used in calculating the

exposure estimate, the actual lifetime

averaged individual exposure to PCDD’s

is expected to be substantially less than

the worst-case exposure, and therefore,

the calculated upper-bound limit of risk

would be less. Thus, the agency

concludes that there is a reasonable

certainty that no harm from exposure to

PCDD’s would result from the proposed

use of the additive.

B. Need for Specifications

The agency has also considered

whether specifications are necessary to

control the amount of PCDD’s as

impurities in the additive. The agency

finds that specifications are not

necessary for the following reasons: (1)

Because low levels of PCDD’s may be

expected to remain as impurities

following production of the additive,

the agency would not expect these

impurities to become components of

food at other than extremely small

levels; and (2) the upper-bound limits of

lifetime risk from exposure to these

impurities, even under worst-case

assumptions, are very low, less than 2.1

in 100 billion for PCDD’s.

III. Conclusion

FDA has evaluated data in the

petition and other relevant material and

concludes that the proposed use of the

additive as a colorant in food-contact

polymers is safe. Based on this

information, the agency has also

concluded that the additive will have

the intended technical effect. Therefore,

§ 178.3297 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 21 CFR

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.

IV. Environmental Impact

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

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

V. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Memoranda from the Chemistry Review

Branch (HFS–247) to the Indirect Additives

Branch (HFS–216) concerning FAP 3B4383—

BASF Corp.—exposure to the food additive

and its component (polychlorinated dibenzop-dioxins, PCDD’s) dated January 21, 1994,

April 19, 1994, and March 10, 1995.

2. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology,’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger and J. K. Marquis, S. Karger, New

York, pp. 24–33, 1985.

3. EPA 560/5–90–014, Background

Document to the Integrated Risk Assessment

for Dioxins and Furans from Chlorine

Bleaching in Pulp and Papermills, pp. 3–13,

July, 1990.

4. Pilot Study on International Information

Exchange on Dioxins and Related

Compounds, Report No. 178, December,

1988.

5. Kociba, R. J. et al., ‘‘Results of a Two

Year Chronic Toxicity and Oncogenicity

Study of 2,3,7,8-Tetrachlorodibenzo-p-dioxin

in Rats,’’ Toxicology and Applied

Pharmacology, 46:279–303, 1978.

6. Report of the Quantitative Risk

Assessment Committee, ‘‘Carcinogenic Risk

Assessment for Dioxins and Furans in Foods

Contacting Bleached Paper Products,’’ April

20, 1990.

7. ‘‘2,3,7,8-Tetrachlorodibenzo-p-dioxin in

Sprague-Dawley Rats,’’ Pathco, Inc., March

13, 1990.

8. Report of the Quantitative Risk

Assessment Committee of the Center for Food

Safety and Applied Nutrition, FDA, ‘‘UpperBound Lifetime Carcinogenic Risk From

Exposure to Dioxin Congeners From Foods

Contacting Paper Products With Dioxin

Levels Not Exceeding 2 ppt,’’ January 27,

1993.

9. Memorandum, Report of the

Quantitative Risk Assessment Committee of

the Center for Food Safety and Applied

Nutrition, FDA, ‘‘Estimation of upper-bound

lifetime risk from polychlorinated dibenzo-pdioxins in C. I. Pigment Yellow 138,’’ May

24, 1994.

VI. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before February 26, 1996, 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 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:
2116 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.3297 is amended in

paragraph (e) in the table by

alphabetically adding a new entry under

the headings ‘‘Substances’’ and

‘‘Limitations’’ to read as follows:

§ 178.3297 Colorants for polymers.

* * * * *

(e) * * *

Substances Limitations

* * * * * * *

4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-

dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolinyl]-1Hisoindole-1,3(2H)-dione (C. I. Pigment Yellow 138,

CAS Reg. No.30125–47–4).

For use only at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use C through H, as described in

Table 2 of § 176.170(c) of this chapter; provided further that the finished articles shall

not be filled at temperatures exceeding 158 °F (70 °C).

* * * * * * *

Dated: January 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–1144 Filed 1–24–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

28 CFR Part 49

[AG Order No. 2005–96]

RIN 1105–AA37

Use and Examination of Materials

Submitted Pursuant to the Antitrust

Civil Process Act

AGENCY: Department of Justice.

ACTION: Final rule.

SUMMARY: This rule finalizes changes

made by an interim rule published on

August 25, 1995 at 60 FR 44276 to a

Department of Justice regulation

concerning the use and examination of

materials submitted pursuant to the

Antitrust Civil Process Act (‘‘ACPA’’ or

‘‘Act’’). The interim rule added

references to ‘‘answers to

interrogatories’’ and ‘‘transcripts of oral

testimony’’ as types of material subject

to the provisions of the ACPA and also

added references to ‘‘agents’’ of the

Department of Justice having the

authority to use and copy such

materials. These changes were necessary

to conform the language of the

regulation to the current provisions of

the Act. The interim rule also made

minor changes to the spelling and

capitalization of certain words used in

the regulation for purposes of

conformity with the Act and internal

consistency.

DATES: This Final Rule is effective

January 25, 1996.

FOR FURTHER INFORMATION CONTACT:

Howard Blumenthal, Assistant Chief,

Legal Policy Section, Antitrust Division,

Room 3121, Main Justice Building, 10th

& Pennsylvania Avenue NW.,

Washington, DC 20530; telephone (202)

514–2513.

SUPPLEMENTARY INFORMATION: Congress

enacted the ACPA, Pub. L. No. 87–664

(codified at 15 U.S.C. 1311–14, as

amended), in 1962 to provide the

Antitrust Division (‘‘Division’’) of the

Department of Justice with the authority

to issue civil investigative demands

(‘‘CIDs’’), a type of pre-complaint

compulsory process. CIDs enable the

Division to gather information

concerning possible civil violations of

the antitrust laws before filing lawsuits,

which often permits the Department of

Justice to determine that no antitrust

violation has occurred without resort to

litigation. Thus, the use of CIDs will

frequently save the Department of

Justice, the parties being investigated,

and the federal court system time and

money through the avoidance of

unnecessary litigation or the

streamlining of any litigation that does

result from an investigation.

The CID authority provided to the

Division in 1962 was relatively narrow.

The only type of information that the

Division could acquire by CID was

documentary material. Without the

consent of the person who produced

such material, access to CID information

in the possession of the Division was

generally limited to officers, members,

or employees of the Department of

Justice.

The Division’s CID authority was

expanded by the Hart-Scott-Rodino

Antitrust Improvements Act of 1976

(‘‘HSR Act’’), Pub. L. No. 94–435. In

addition to producing documentary

material, CID recipients could now be

required to answer in writing written

interrogatories and to give oral

testimony. In the Antitrust Procedural

Improvements Act of 1980 (‘‘APIA’’),

Pub. L. No. 96–349, Congress clarified

that CID information in the possession

of the Division could be disclosed to

and used by agents of the Department of

Justice (for example, expert witnesses or

independent contractors) as well as by

officers and employees.

The ACPA requires the Attorney

General to promulgate regulations

setting forth the manner in which CID

materials in the possession of the

Division will be made available for

official use by the Department of Justice,

and to prescribe the terms and

conditions under which such materials

may be examined by the persons who

produced them to the Division. The

Attorney General promulgated 28 CFR

part 49 in 1963 to comply with this

requirement. However, this regulation

was not amended to reflect the changes

to the Act made by the HSR Act in 1976

or the APIA in 1980. The purpose of this

order is to make final an interim rule

published on August 25, 1995 at 60 FR

44276, which amended the pre-existing

regulation to conform with the current

provisions of the ACPA.

The rule now being finalized differs

from the pre-existing regulation in two

main respects. First, references in the

pre-existing regulation to the use and

examination of documentary material in

the possession of the Division were

expanded, where and as appropriate, to

also refer to answers to interrogatories

and transcripts of oral testimony to take

into account the additional types of

information that can be acquired under

the ACPA as amended by the HSR Act.

Second, references to the use and

copying of CID information by officers

and employees of the Department of

Justice were expanded to also include

agents of the Department of Justice to

reflect the change to the Act made by

the APIA. The rule now being finalized

also differs from the pre-existing

regulation in several technical respects.