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Citation: 61 Fed. Reg. 52287 1996

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### Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations 52287

4. Section 355.50 is amended by revising paragraphs (c)(1) and (c)(2), and in the headings for paragraphs (d)(1)(i) and (d)(1)(ii) by removing the word "Paste" and adding in its place the words "Gel or paste" to read as follows:
§355.50 Labeling ofanticarles drug products.

*t * * * *

(c) * * * (1)Forall fluoridedentifrice(gel, paste,andpowder) products."Keep out ofthe 'reach ofchildren under 6 years ofage. Ifyou accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately." These warnings shall be used in place ofthe general warning statements required by § 330.1(g) ofthis chapter.

(2) Forall fluoriderinseand preventive treatmentgelproducts. "Keep this and all drugs out ofthe reach ofchildren. If you accidentally swallow

more than used for" (selectappropriate word: "brushing" or "rinsing"), "seek professional assistance orcontact a Poison Control Center immediately." These warnings shall beused inplace ofthe general warning statements required by § 330.1(g) ofthis chapter.

Dated: September 30, 1996. William K. Hubbard, AssociateCommissioner forPolicy Coordination. [FR Doc.96-25599 Filed 10-4-96; 8:45 am]

BILUNG CODE 4160-01-P

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

21 CFR Parts 1309, 1310, 1313
[DEA NUMBER 138P]
RIN 1117-AA32

Removal of Exemption for Certain Pseudoephedrine Products Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act)

AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Final rule; withdrawal.

SUMMARY: DEA is withdrawing its rulemaking regarding Removal of Exemption for Certain Pseudoephedrine Products Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act) which was published in the Federal Register on August 7, 1996 (61 FR 40981). The final rule has been superseded by the Comprehensive Methamphetamine Control Act of 1996, 

### which declares the final rule null and void and ofno effect.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief,Drug and 

### Chemical Evaluation Section, Office of Diversion Control, DrugEnforcement Administration, Washington, DC. 20537, Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION: DEA published a notice ofproposed rulemaking (NPRM) regarding Removal 

### ofExemption for Certain Pseudoephedrine Products Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act) inthe Federal Register on October 31, 1995 (60 FR 55348). The NPRM proposed certain amendments to Title 21, Code ofFederal Regulations (CFR), Parts 1309, 1310, and 1313, and

was open for public comment until January 2, 1996. Following thecomment period, DEA published a final rulemaking on August 7, 1996 (61 FR 40981), which was tobecome effective

on October 7,1996. However, on September 29, 1996, Congress passed the Comprehensive Methamphetamine Control Act of1996, which provides that "The final rule concerning removal ofexemption for certain pseudoephedrine products marketed under the Federal Food,Drug, and Cosmetic Act published in theFederal Register ofAugust 7, 1996 (61 FR 40981-40933) is nulland void and ofno force or effect." As a result, the amendments contained inthe final rule

are canceled and the regulatory text of 21 CFRParts 1309, 1310, and 1313 remains unchanged.

Accordingly, DEA's rulemaking entitled Removal ofExemption for Certain Pseudoephedrine Products Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act), published in the Federal Register asa proposed rule

on October 31, 1995 (60 FR55348) and

as a final rule onAugust 7, 1996 (61 FR 40981), is withdrawn.

Dated: October 2,1996. Gene R.Haislip, Deputy AssistantAdministrator, Officeof DiversionControl. [FR Doc. 96-25665 Filed 10-4-96; 8:45 am]

BILUNG CODE 4410-09-M ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Parts 9 and 721 [OPPTS-60617A; FRL5396-6]
RIN 2070-AA58

Benzidine-Based Chemical Substances; Significant New Uses of Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: EPA is promulgating a significant new use rule (SNUR)under section 5(a) ofthe Toxic Substances Control Act (TSCA)which requires
persons to notify EPA at least 90 days before commencing the manufacture, import, orprocessing ofcertain benzidine-based chemical substances for any significant new use as described in this rule.EPA believes that this action is necessary because benzidinebased chemical substances may be hazardous to human health and that the

uses governed by this rule may result in significant exposure to workers handling those substances. The required notice provides EPA with the opportunity to evaluate any intended

new uses and associated activities before the benzidine-based chemical substances can be introduced into the marketplace for a significant new use, and an opportunity to protect against potentially adverse exposure before it

occurs.
EFFECTIVE DATE: This rule becomes effective on November 20, 1996. Persons who begin commercial manufacture, importation, or processing oflisted benzidine-based chemical substances for any significant new use listed in this rule between August 30, 1995, and November 20, 1996 must comply with the requirements ofthis final SNUR. See Unit VII ofthis preamble for more information. In accordance with 40 CFR 23.5, this rule shall be promulgated for purposes ofjudicial review at 1 p.m. eastern time on October 21, 1996.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (7408), Office ofPollution Prevention and Toxic Substances, Environmental Protection Agency, 401 M St., SW., Rm. E-545, Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551; e-mail: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: This SNUR requires persons to notify EPA at

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### 52288 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

least 90 days .beforecommencing the manufacture, import, or processing of the benzidine-based chemical substances listed in thisrule for any significant new use as described in §721.1660(a)(2). The SNUR does not apply to usesofbenzidine-based substances inexistence when this SNUR

was proposed whichinclude uses as: A reagent to testfor hydrogen peroxide in milk; areagent to test forhydrogen sulfate, hydrogen cyanide, and nicotine;

a stain inmicroscopy; a reagent for detectingblood; an analytical standard; and also for Colour Index (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58- 0) as an indicator dye. Therequired notification willprovide EPAwith information needed to evaluate the new
use and associated activities, and an opportunity to protect against potentially adverse exposure to the chemical substance before it can occur. This rule was proposed on August 30, 1995 (60FR 45119) (FRL-4762-4).

Regulatedentities.Entitiespotentially regulated by this action are those which manufacture, import, orprocess the benzidine-based chemical substances listed inthe rule for anyuse other than those listed in §721.1660(a)(2). Regulated categories and entities include:

Category Examples ofregulated enti- ties
Industry Manufacturers, importers, and processors ofcyclic organic crudes and intermediates, and organic dyes. Industry Entities which plan to use the listed dyes inconjunc- tion with apparel and other finished products made from fabrics, leather, and similar materials. Industry Entities which planto use the listed dyes inconjunction with paper and allied products. Industry Manufacturers, importers, and processors ofprinting ink.

This table is not intended to be exhaustive, butrather provides a guide forreaders regarding entities likely to be regulated by this action. Thistable lists the types ofentities that EPAis now
aware could potentially be regulated by this action. Other types ofentitiesnot listed in thetable could also be regulated. To determine whether your business is regulated by this action, carefully examine the applicability criteria set forth in §721.1660 ofthis rule. For questions regarding the applicability ofthis actionto a particular entity, see "FOR FURTHER INFORMATION CONTACT" atthe beginning ofthis document.

I. Authority

Section 5(a)(2) ofTSCA (15U.S.C. 2604(a)(2)) authorizes EPAto determine thata use ofachemical substance is a "significant new use." The Agency must make this determination by rule after considering all relevant factors, including those listed in section 5(a)(2). Section 5(a)(2) factors generally relateto the extent thata use changes the volume ofa chemical substance's production or the type, form, magnitude, orduration ofexposure to it. Once EPA determines byrule that a use ofachemical substance is a significant new use, section 5(a)(1)(B) ofTSCA requires persons to submit a significant new use notice (SNUN) to EPA atleast 90 days before manufacturing, importing, or processing the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).

Persons subject to this SNUR must complywith the same notice requirements and EPA regulatory procedures as submitters of premanufacture notices (PMNs) under section 5(a)(1)(A) ofTSCA (15 U.S.C. 2604(a)(1)(A)). Inparticular, these requirements include the information submission requirements ofTSCA sections 5(b) and (d)(1), the exemptions authorized by TSCA section 5 (h)(1), (2), (3), and (5), and the regulations at40 CFR part 720. If duringits review, EPA identifies concerns, regulatory action may betaken under TSCA section 5(e), 5(f), 6, or7to control the activities for which it has received a SNUN (15 U.S.C. 2604 (e), (0, 2605, 2606). IfEPA does not take action, section 5(g) of TSCA requires EPA to explain in the Federal Register itsreasons for not taking action (15 U.S.C. 2604(g)).

Persons who intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)). The regulations that interpret section 12(b) appear at40 CFR part 707. Persons 

### who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements, and to theregulations codified at 19 CFR 12.118 through 

### 12.127 and 12.128. Such persons must certify thatthey are in compliance with TSCA requirements. The EPA rule in support ofimport certification appears at 40 CFR part 707. 

### II. Applicability ofGeneral Provisions
General regulatory provisions applicable to SNURs are codified at 40 CFR part 721, subpart A. In the Federal Register ofAugust 17, 1988 (53 FR 

### 31252), EPA promulgated a "User Fee Rule" (40 CFR part 700) under the authority ofTSCA section 26(b) (15 U.S.C. 2625(b)). Provisions requiring persons submitting SNUNs to submit certain fees to EPAare discussed in detail inthe FederalRegister document. Interested persons should refer to 40 CFRparts 700 and 721 and the August 17, 1988 FederalRegister document for further information.
III.Introduction

A. Summary



### The chemical substances that are the subjects ofthis SNUR are certain benzidine-based chemical substance as listed intable 1

### of§721.1660.

EPA has determined that there is no ongoing manufacture, import, or processing, ofthe listedbenzidine-based chemical substances, except for the ongoing uses ofsuch substances in small amounts for a few, limited purposes (identified in § 721.1660(a)(2) of thisrule). Because the listed benzidine-based chemical substances

are currently only used forthese limited purposes, EPA is concerned that any
new usebeyond the current ongoing limited uses would increase production volume resulting inincreased potential forexposure to workers which wouldbe significant because oftheir potential carcinogenicity. Therefore, under TSCA section 5(a)(2), EPA is designating any
use ofthe listedbenzidine-based chemical substances asa significant

new use, other than the following ongoing uses ofsuch chemical substances: As areagent to test for hydrogen peroxide in milk; a reagent to testfor hydrogen sulfate, hydrogen cyanide, andnicotine; a stain in microscopy; a reagent for detecting blood; an analytical standard; and also forC. I.Direct Red 28 as an indicator dye.

Except for the ongoing uses listed above, thisrule requires personswho intend to manufacture, import,or process the benzidine-based chemical substances listed in table I of§721.1660 

### ofthisrule to notify EPA through the submission ofa SNUN, at least 90 days before commencing themanufacture, importation, or processing ofany of these substances for the significant new
uses designated in this SNUR.The required notice provides EPA with the opportunity to evaluate the intended
use, and, ifnecessary, to prohibit or limit that usebefore it occurs.

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B.FinalRule-ChangesFromthe ProposedRule

The Agency reviewed all comments received on the proposed rule. After consideration ofissues raised by the commenters, the Agency has taken the following actions:

1. Some inconsistencies in naming and inaccuracies in CAS numbers in table 1 of40 CFR 721.1660 have been corrected.

2. Chemical substances not listed on the TSCA Inventory are no longer covered by this rule.

3. The use ofC.I. Direct Red 28 (CAS No. 573-58-0) as an indicator dye and the use ofbenzidine-based chemical substances as an analytical standard

were added to the list ofuses not designated as significant new uses under this SNUR.
IV. Background Information on Benzidine-Based Chemical Substances

Based upon toxicity information on benzidine and benzidine-based dyes, the Agency is concerned that all the benzidine-based chemical substances listed inthis rule may becarcinogens.

The molecule benzidine can onlybe isolated for commerce oruse in the form ofa salt.In recognition ofthis fact, whenever the term "benzidine" is used in this section ofthe preamble, it refers to the molecule benzidine, CAS No. 92- 87-5, as well as to all benzidine salts.

Benzidine is an aromatic amine that has been used as a feedstock for production ofman-made dyes since the late 1800's. Dyestuffs were among the first products ofthe developing chemical industry, and aromatic amines

were the first synthetic chemicals found to cause cancer inhumans. This was first reported in the last century, when

some workers manufacturing dyes developed bladder cancer. Benzidine

was subsequently found tobe a potent carcinogen in humans and animals.

Several epidemiologic studies of occupationally exposed workers have demonstrated that benzidine exposure is associated with a high risk of developing bladder cancer (Ref. 1). Benzidine is classified by EPA as Group A, a human carcinogen (IRIS, 1996). Benzidine is also classified by the International Agency for Research on Cancer (IARC) as aGroup I carcinogen, which are chemicals known to cause
cancer in humans and animals (Ref. 2).

Originally, only benzidine was considered to be carcinogenic. However, studies found that dyes derived from benzidine release freebenzidine via metabolic routes (Ref.3). The dyes were predicted to be carcinogens based on these findings. Animal bioassays performed by the National Cancer Institute (NCI) in 1978 confirmed that administration ofthree different benzidine-based dyes each led to

cancer. (Ref.4)

EPA's hazard analysis (Ref.5) is based

on studies oftested representative benzidine-based dyes, as well as benzidine, from which they are synthesized, and to which they break down ormetabolize. The overwhelming health concern for benzidine and benzidine-based dyes is for bladder

cancer generally believed to be caused through any route ofexposure. As of June 1974, the Occupational Safety and Health Administration (OSHA) requires thatmanufacture ofbenzidine be contained within a closed system (29 CFR 1910.1010 Benzidine). In addition, the American Conference of Governmental Industrial Hygienists (ACGIH) has classified benzidine as a "confirmed human carcinogen" with no Threshold Limit Value (TLV) assigned, and has recommended that "all exposure to benzidine should be kept to
an absolute minimum" (Ref.6).

Twelve benzidine-based dyes have been demonstrated to metabolize to benzidine in one or more offour species (Ref. 7). National Toxicology Program (NTP) cancer bioassays by the oral route in rodents using Direct Black 38 (CAS No. 1937-37-7), Direct Blue 6 (CAS No. 2602-46-2), and Direct Brown 95 (CAS No. 16071-86-6), showed statistically significantly elevated tumor incidence ofthe liver fbllowing oral administration. The time to tumor formation was 5 to 13 weeks. No tumors

were found inthe controls (Ref.4). In response to these and other data, the National Institute for Occupational Safety and Health (NIOSH) and NCI have jointly recommended that these three dyes be handled in the workplace

as ifthey were human carcinogens, and have suggested guidelines for minimizing employee exposure (Ref.8).

Bioavailability studies in Rhesus monkeys, rats, and dogs revealed levels ofbenzidine in theurine, after the administration ofthe above-mentioned dyes, equivalent to the levels found after administration ofa comparable volume ofstraight benzidine (Refs. 3 and 7). For this reason, IARC has classified these benzidine-based dyes as Group 2A chemicals, which are carcinogenic to animals and probably carcinogenic to humans (Refs. 1, 8, and 9). Given the consistent results from testing these dyes, as well asknown mechanistic similarities among benzidine-based dyes, the entire class ofbenzidine-based dyes are expected to have a similar degree oftoxicity. In addition, NIOSH has recommended that all benzidinebased dyes be recognized as potential human carcinogens, based upon the evaluation ofinformation on the carcinogenicity and metabolism ofthese dyes (Ref. 10).

There are exposure issues for both the parent amines and the finished dyes. Most available exposure data are for groups ofdyes, rather than for individual dyes. Inhalation, skin absorption, and ingestion are possible routes ofexposure in a variety of settings where benzidine-based dyes are either manufactured orused. Benzidine and monoacetyl benzidine, a metabolite, havebeen found inthe urine ofworkers making or using benzidine-based dyes in the paper, textile, leather, and dye manufacturing industries (Ref. 10). The amount ofbenzidine found in the urine

was more than could be accounted for by only benzidine impurities in the dyes.

Exposure estimates for dyes were developed based on theresult ofa monitoring study conducted collaboratively by EPA and industry (Ref.11). Using this information, and based on models from EPA and industry, exposure estimates have been calculated for those workers who weigh powder dyes in manufacturiig establishments. From these estimates, EPA predicts the highest exposure would occur for workers who would manufacture benzidine-based dyes or who would weigh such dyes, and is also concerned about potential exposures to workers who would operate dyeing machinery (Ref.11).
V. Rationale and Objectives for the Rule

To determine what would constitute a significant new use ofbenzidine-based chemical substances, EPA considered relevant information regarding the toxicity ofthe substances, likely exposure and releases associated with potential uses, and the four factors listed in TSCA section 5(a)(2). The Agency has concerns for bladder cancer in workers which is generally believed to be caused through any route of exposure to benzidine-based chemical substances (Ref. 5). EPA classified benzidine as Group A, a human carcinogen (IRIS, 1996). Benzidine has

an IARC classification as a Group 1 carcinogen, which are chemicals known to cause cancer inhumans and animals. IARC has also classified several benzidine-based dyes as Group 2A chemicals, which are carcinogenic to animals and probably carcinogenic to humans. Thebenzidine-based dyes that have not been tested are also suspected carcinogens (e.g., Ref. 10).

EPAhas determined that there is no ongoing manufacture, import, or

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### 52290 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

processing, ofthe listed benzidine-based chemical substances, except foruse in small amounts as areagent to test for hydrogen peroxide in milk; areagent to test forhydrogen sulfate, hydrogen cyanide, and nicotine; astain in microscopy; areagent for detecting blood; an analytical standard; and also for C.I. Direct Red 28 asan indicator dye. EPAbelieves thatthe use ofthe subject benzidine-based substances for the uses designated at §721.1660 would result in increases in production as well

as the type, form, magnitude, or duration ofexposure tothese known or suspected carcinogens. Therefore, EPA is designating the uses at §721.1660 as significant newuses (Ref. 12).

Based on these considerations, EPA wishesto achieve the following objectives with regard to the significant

new uses that are designated in this rule. Specifically, EPAwants to ensure that it:

1.Receives notice ofany company's intent tomanufacture, import, or process the benzidine-based chemical substances forthe significant new uses designated inthis rulebefore that activity begins.

2.Has an opportunity to review and evaluate data submitted ina SNUN before the notice submitterbegins manufacturing, importing, orprocessing the listed benzidine-based chemical substances forthe significant new uses designated in thisrule.

3.Can regulate prospective manufacturers, importers, or processors ofthe listedbenzidine-based chemical substances before any significant new
use occurs,provided that the degree of potential healthrisk is sufficient to warrant such regulation.

Forthe preceding reasons, EPA is designating any use ofthebenzidinebased chemical substances listed in §721.1660, except forthose useslisted in §721.1660(a)(2), as significant new
uses. VI. Alternatives

Before promulgating this SNUR, EPA considered alternative regulatory actions for the listedbenzidine-based chemical substances. It determined that

- -the-benzidine-based chemical substances listed inthis rule are currently not subject to Federal notification requirements nor are they currently subject to any other Federal rules that regulate risks to human health

orthe environment to a sufficient extent tojustify using those regulations asan alternative to this SNUR. EPA also considered the following alternative actions.

1.PromulgateaTSCA section 8(a) reportingrule forthese chemical substances.Under such a rule, EPA could require anyperson to report information to the Agency when they intend to manufacture, import, or process the listed benzidine-based chemical substances, for a significant

new use as listed in this rule (15 U.S.C. 2607). However, inthe case ofthese particular chemical substances, the use ofsection 8(a) rather than SNUR authority would not provide the opportunity for EPA toreview human and environmental risks associated with

new uses ofa chemical substance and, ifnecessary, take immediate follow-up regulatory action under TSCA section 5(e) or section 5{f to prohibit or limit the activity before it begins. In view of the level ofhealth concerns for the listed benzidine-based chemical substances, the Agency believes that a section 8(a) rule forthose chemical substances would not meet EPA's regulatory objectives.

2. Regulatethe listedbenzidine-based chemicalsubstancesundersection 6 of TSCA. EPA may regulate under section 6 ifthere is a reasonable basis to conclude that the manufacture, importation, processing, distribution in
commerce, use, or disposal ofa chemical substance or mixture "presents or will present" an unreasonable risk ofinjury to human health orthe environment. A finding of unreasonable riskindicates a determination that the reduction of health orenvironmental riskresulting from apotential regulation outweighs the regulatory burden to society.

In the case ofthis rule, EPA decided that a SNUR was more appropriate than

a section 6 rule because the Agency has
not determined that the ongoing uses raise sufficient concerns tojustify a section 6 regulation. At the same time, EPA's concerns are for potential future

uses, and the notification which is required by this SNUR will be sufficient
to allow the Agency to make the decisions necessary to protect against such uses.
VII. Applicability to Uses Occurring Before Effective Date ofthis Final Rule

EPAbelieves that the intent ofsection 5(a)(1)(B) isbest served by designating

a use as a significant new use as ofthe proposal date ofthis SNUR rather than

as ofthe effective date ofthis final rule. Ifuses begun during theproposal period ofa SNUR were considered ongoing, rather than new, as ofthe effective date, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new

use before the rule became final, arguing that the use is no longer new. Persons who began commercial manufacture, importation, orprocessing ofthe listed benzidine-based chemical substances forany significant new use listed in this rule between issuance of the proposed rule and the effective date ofthis SNUR must cease that activity before the effective date ofthis rule. To

resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the noticereview period, including all extensions, expires. If, however, persons who began commercial manufacture, importation,

or processing ofthe chemical substances between the issuance ofthe proposed rule and the effective date ofthis SNUR
meet the conditions ofadvance compliance ascodified at §721.45(h), those persons will be considered to have
met the requirements ofthis final SNUR for those activities.

VIII. Response to Comments Received

on Proposed Rule

The Agency received comments on the proposed rule from two businesses and two trade associations. The Agency reviewed and considered all significant
comments received. These comments and EPA's responses follow:

Comment. Some ofthe dyes listed in the proposed rule are assigned incorrect
CAS numbers and nomenclature.

Response.EPA reviewed the list of dyes in the proposed rule. Inconsistencies innaming substances

were identified and corrected in table 1 in § 721.1660 ofthis final rule. Inaccurate CASnumbers were also identified and corrected intable I of this final rule for C.I. Direct Blue 2 (CAS No. 2429-73-4), C.I.Direct Brown 6 (CAS No. 2893-80-3), and C.I.Direct Brown 74 (CAS No. 8014-91-3). Additionally, chemical names were added to table 1 ofthis rule to futher identify substances subject to SNUR reporting. These corrections were minor in nature and didnot change the types ofbenzidine-based dyes subject to this final SNUR.

Comment.A majority ofthe chemical substances listedin the proposed rule

are not found on the TSCA Inventory. A SNUR for substances that are not on the TSCA Inventory is unnecessary because the "PMN would serve the same purpose".

Response.EPA conducted areview of the TSCA Inventory. This review revealed that 24 out of 149 benzidinebased chemical substances inthe proposed SNUR were'on the TSCA Inventory and the remaining substances

were not. EPA has removed the substances that are not on the TSCA Inventory from the final list of

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substances requiring notification ofa significant new use. Those substances continue to be subject tothe reporting requirements under TSCA section 5(a)(1) (15 U.S.C. 2604(a)(1)). Section 5(a)(1) requires a person who manufactures achemical substance that is not onthe Inventory, and not otherwise excluded or exempted from the requirements of section 5, to file a premanufacture notification (PMN) with EPA. When EPA proposed the SNUR it basedthe proposal on certain objectives that it announced inthe preamble to the proposed rule (60 FR 45121, August 30, 1995). EPA has concluded that these

same objectives can be metthrough the submission ofaPMN for benzidinebased chemical substances that are not
on the Inventory and requiring a SNUN in addition is notnecessary.

Comment.C.I. Direct Red 28, a benzidine derivative, is used as a mineral acid indicator but wasnot identified in the proposed rule asan ongoing use. Also, certain uses of benzidine as an analytical laboratory standard, as withEPA Reference Method 8270, are also ongoing. These

uses are similar to other ongoing uses identified in the proposed rule.

Response.EPA added the use ofC.I. Direct Red 28 (CASNo. 573-58-0) as an indicator dye andthe use ofbenzidine and benzidine-based chemical substances as an analytical standard to the list ofongoing usesbased on information fromcommenters and EPA's Office ofSolid Waste and Emergency Response (OSWER) (Benzidine SNUR Memo, 50617A). No additional ongoing uses ofbenzidinebased chemical substances were identified. Ongoing uses, asidentified in §721.1660(a)(2) ofthis final rule, are not subject to SNUR reporting. EPA decided to add these two usesbecause they are similar to other ongoing uses that were originally proposed. Like

some oftheproposed ongoing uses, the additional usesrely on benzidine-based substances to test forthe presence of chemical substances. EPA received no objections tothe inclusion ofthe original uses in this SNUR and has concluded that additional notice is not necessary to add these similaruses.

Comment.There are other benzidinebased dyes on the TSCA Inventory whichwere not listed in theproposed rule.

Response.EPA's intent is to require notification prior to themanufacture, import, orprocessing ofallbenzidinebased chemical substances on the TSCA Inventory for allnon-ongoing uses. EPA conducted a thorough search ofthe TSCA Inventory which revealed that there are additional benzidine-based chemical substances on the TSCA Inventory that were not included inthe proposed SNUR. EPA will propose a SNUR for these additional benzidinebased chemical substances inthe near future.

Comment.EPA should exempt all laboratory uses ofvery small amounts of benzidine-based chemical substances from the SNUR where prudent laboratory practices are employed. Another comment suggested that the SNUR should not apply to laboratory

uses ofbenzidine-based chemical substances.

Response. EPA agrees with the first comment and under existing EPA regulations, aperson who manufacturers, imports, orprocesses a listed substance for a significant new
use is not subject to SNUR notification requirements ifthe person is utilizing small quantities for research and development and meets the other safeguards as specified in 40 CFR 721.47. In addition, this SNUR will not

cover identified laboratory uses which

are ongoing (listed in §721.1660(a)(2) of this rule). However, EPA does not agree with the second comment that all laboratory uses in general should be excluded. The purpose ofthe SNUR is to insure thatEPA has an opportunity to review human and environmental risks associated with significant new
uses ofa chemical substance and, if necessary, take further action to protect against those risks. IfEPA exempts all laboratory uses without any ofthe safeguards specified in 40 CFR 721.47,

as suggested by the commenter, then persons may engage inthose uses without further EPA review ofthese additional human and environmental exposures. The comment did not provide adequate information to allow EPA to determine theextent orpossible consequences ofthese exposures. Given the potentially hazardous nature of benzidine-based chemical substances, EPAbelieves it is not appropriate to exempt all -laboratoryuses from the SNUR. Anyone who wishes toengage in such anew use in the future, however, may submit a significant new use notice and initiate theprocess for determining whether those uses pose an unreasonable risk.

Comment.The use ofbenzidine as a laboratory standard or an indicator dye does not constitute manufacturing, importing, orprocessing for a commercial purpose, i.e., for distribution in commerce. The analytical procedures, ofwhich the benzidine is part, either consume the benzidine orproduce by-products which are properly disposed. No benzidine is manufactured or processed 

### inthe course ofthese uses, nor is it for the purpose ofdistribution in

commerce.

Response.EPAgenerally agrees with the commenter thAt a SNUR only regulates manufaaturing andprocessing activities that are undertaken for commercial purposes; however, a laboratory could be engaging in regulated activities when it uses a listed benzidine-based chemical substance. TSCA provides that SNURsapply only topersons who "manufacture or process" subject substances (15 U.S.C. 2604(a)(1)(B)). TSCA also defines the 

### term "manufacture" to include importation ofaswell asproduction (15 U.S.C. 2602(7)). TSCA furtherprovides that SNURs only regulate manufacturing, importation, and processing activities ifthose activities

are for "commercial purposes" (15 U.S.C. 5(I)). EPA interprets these provisions broadlyto encompass a wide range ofactivities. TSCA and the SNUR regulations define manufacturing to include any activities associated with the production or importation of substances withthe purpose of obtaining an immediate or eventual commercial advantage forthe manufacturer or importer (40 CFR 720.3(r), defining "manufacture or import forcommercial purposes"). Processing forcommercial purposes is also defined to encompass awide range ofactivities (40 CFR 721.3, defining 

### "process for commercial purposes"). Based upon these regulations, a laboratory couldbe engaged inregulated activity when it uses alisted benzidinebased substance. Determining whether a laboratory is engagedin a regulated activity is very fact specific and requires

an assessment ofa variety ofthe 

### circumstances surrounding the laboratory's activities. The commenter has notprovided enoughinformation forEPA to determine whether the activities it describes would besubject to the SNUR. Rather than speculate on hypothetical situations, EPA advises a laboratory that intends to engage in activities involving a significant new
use ofa listedbenzidine-based chemical substance to contact EPA as specified in 40 CFR 721.11 to determine in advance whether it is subject to the SNUR. Additionally, as stated inthe previous response to comment, under existing EPA regulations, a person who manufactures, imports, orprocesses a listed substance fora significant new
use is not subject to SNUR notification requirements ifthe person isutilizing small quantities ofresearch and development and meets the other

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### 52292 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

safeguards as specified in 40 

### CFR 721.47.

Comment.The SNUR will give an unfair advantage to foreign producers of benzidine-based chemical substances, andto those who imblt textiles dyed with such chemicals into the US.

Aesponse.While EPA does not presently have a sufficient basis to support a regulatory action related to the import ofarticles manufact red with benzidme-based chemical siAsmwes,

we have taken steps to addess concerns wi s eine-based chemical' substances on an international -evel. EPAhas helped theO(gauzzation for Economic 'Cooperation and Development {OECD) organize an information clearinghouse so the OECD member oountries can share inknuation regarding theissues, concerns, and risk management activities surrounding benzidine-based chemical substances. EPA has also provided information to India through the U.S. Department of State. EPAplans to inform the OECD, United Nations (UN) International Program on Chemical Safety (IPCS) and the International Register ofPotentially Toxic Chemicals (IRPTC) ofthe issuance ofthis SNUR so thatthis action might
encourage other countries to examine the risks associated withthe manufacture and use ofbenzidine-based chemical substances in their countries.

Comment.The SNUR is a "complete product ban", put into effect without "sufficient analysis ofthe alternatives and input from the interested public".

-Response. EPAdisagrees. A SNUR requires only that manufacturers, importers, and processors ofthelisted substances notify EPA at least 90 days before beginning any activitythat EPA has designated as a "significant new use." The advance notification required by the SNUR allows EPA to evaluate the proposed new use in more detail. Ifthat evaluation reveals aconcern, EPA can take action to prevent or limit unreasonable risk from the new use of the substance. Conversely ifEPA decides not to take any further action, the activity may proceed.

EPA also disagrees with the comment thatit failed to analyze alternatives or public input. The commenter failed to explain why it believed that there were other viable alternatives to a SNUR. Unit VI ofthis preamble includes EPA's analysis ofalternative regulatory actions and other provisions ofTSCA. EPA also discussed plans to issue a SNUR at several public meetings, and at a meeting with industry representatives held during inApril, 1995 (Meeting Minutes on Benzidine-Based and Benzidine Congener-Based Dyes, 50617A). Additionally, the public submitted comments whenthis SNUR

was proposed and EPA is responding to them in this preamble.

Comment.'EPA has notaddressed the issue ofthe "actual risk posedby these c1emicals in their curent limited use".

.Response.Because this SNUX'is not inteded to subject ongoing usesof benzidine-based chemcal substances to 

### SNJM4peiag qirements, EPA did
net pecicallyeassess riskposed %y
.e.g uses .of ezi&.e4bsed 

### c4IecaI sbsmtm. Such an asessmment wouldal otitside the sCope -ofikisrule ddAeidre, isunnecessary to support this rule.

Comment.The ruleas proposed would not reulate signi~cant hew'uses ofan existing product, but rther-would regulate "old, establihed produets and applications which me not currently used" in the U.S.

Response.The statutory language of TSCA section 5, thelegislative history, and underlying policy support EPA's conclusion that it has the authority to classify the resumption of manufacturing orprocessing of chemical substances asa "significant

new use." The term "new" generally
encompasses uses that are occurring for the first time as well asuses that were discontinued and then occur again. See,
e.g., Webster's II New Riverside University Dictionary, 1988.

The factors that TSCA requires the Administrator to considerbefore determining that a use is "significant" and "new" apply equally to first time and resumed uses. Section 5(a)(2) states that the Administrator's "significant

new use" determination shall bemade after considering all relevant factors including "projected volume," increases in "magnitude and duration of exposure," and the reasonably anticipated manner and methods of manufacturing, processing, distribution, and disposal. Both first time and resumed use mayresult in an increase inproduction volume and exposure to

achemical substance. Both types ofuses also can lead to increased risks associated with manufacture, processing, distribution, and disposal.

Moreover, the legislative history of section 5 suggests that Congress intended that increased volume of manufacturing or processing would be subject to the requirements ofthat section. This adds further support to the conclusion that a resumption of manufacture, which necessarily entails

an increase in production volume, may be classified asmanufacture for a significant "new" use. See, e.g.,-H.R. Rep. No. 94-1679, 94th Cong., 2nd Sess. 66 (1976), Legislative History ofthe Toxic Substances Control Act 679; Senate Consideration of Conference Report on S. 3148, Sept. 28, 1976, Legislative History oftheToxic Substances Control Act at 723.

Comment.Thirtydays is not afair and reasonable commentperiod for such complex regulations, with extensive okets' 

### 'Response.EPA disares that3e ays is not a lair aBd reasonAhe comment period.:EPA allows't reasoable ammont of'time for comments booe uponthe complexity oftheproposed rule andthe reoord. Due to the relativwly routine
nature ofSNU]Rs and thelimited nature ofthbe.materol in Ae ,ecatforthis paf6cular rule, the Agency believesthat

a 30-day commeat period is reasonabMe in this case. EPA recived norequests irom the public for an extension ofthe
comment period. Comment.The Agency is not justified in setting retroactive dates as the effective dates for determining new

uses.

Response.EPA disagrees and believes it is reasonable to make the effective date ofthe Agency's "significant new use" determination the proposal date of the rule rather than the date ofthe final rule. IfEPA adopted the date ofthe final rule as the effective date, then a person could defeat the final rule simply by engaging inthe proposed significant

new usebefore therule took effect. Further, the notification requirements foruse ofany listed benzidine-based chemical substance only take effect when the rule becomes final. This rule operates prospectively, not retroactively

as the comment suggests.

Comment.EPA may be premature in "extending its concern to the listed dye products" due to SNUN requirements fortest data, protocol consultation, and human exposure and environmental release data.

Response.EPA disagrees that issuing

a SNUR is premature. Congress designed SNURs to allow EPA to obtain data about new uses ofchemical substances that may pose significant

concerns. This action is based on Agency concerns for all benzidine-based substances listed in the rule. Agency

concerns for all these benzidine-based substances are based on existing carcinogenicity and exposure data of benzidine and benzidine-based substances.

As stated in Unit IX ofthe proposed rule (60 FR45119, August 30, 1995), TSCA section 5 does notrequire persons to develop any particular test data before submitting a SNUN. Persons are required only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (15 U.S.C.

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### Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations 52293

2604(d); 40 CFR 721.25). Further, while EPA does require the submission oftest data in a submitter's possession, EPA does not require the development oftest data when a SNUN is submitted. Rather, EPA suggests to potential SNUR submitters the kind of data thatwould permit a reasoned evaluation of potential risks posedby listed benzidine-based chemical substances for an intended use. The characterization ofpotential health and environmental effects will help the Agency determine if regulation ofthe listed SNUR substance for the intended

use is warranted.

Comment.According to the July 1995 American Association ofTextile Chemists and Colorists (AATCC) Buyer's Guide, 15 companies were listed as distributing benzidine dyes.

Response.Ofthe 15 companies identified in the 1995 AATCC Buyer's Guide as selling benzidine-based chemical substances identified in this SNUR, EPA had previously contacted nine thatwere listed in the 1994 AATCC Buyer's Guide prior to publication ofthe proposed SNUR (Phone Contacts with Benzidine Dye Manufacturers and Distributors, 50617). Representatives ofthose nine companies confirmed that they were not manufacturing, importing, or distributing benzidine-based chemical substances identified in this SNUR. EPA representatives attempted to contact the additional six companies newly listed in the 1995 Buyer's Guide (Buyer's Guide, 50617A). Five companies indicated to EPA that they were not manufacturing, importing, or distributing benzidine-based chemical substances. EPA representatives were unable to contact the remaining company although repeated attempts

were made using the information contained in the 1995 AATCC Buyer's Guide. Thus, based on theinformation currently available, EPA does not believe that thebenzidine-based chemical substances identified in this SNUR are in commerce at this time.
IX. Test Data and Other Information

EPA recognizes thatunder TSCA section 5, persons are notrequired to develop any particular test data before submitting a significant new use notice. Rather, persons are required only to submit test data in their possession or control and to describe any other data known to, orreasonably ascertainable by, them (15 U.S.C. 2604(d); 40 CFR 721.25).

However, inview ofthe potential health risks that may be posedby a significant new use ofthe listed benzidine-based chemical substances, EPA suggests potential SNUR notice submitters include data thatwould permit a reasoned evaluation ofrisks posed by these chemical substances when utilized for an intended use. EPA currently believes that the results ofthe following tests could help adequately characterize possible health and environmental effects ofthe chemical substances: Cancer bioassays, metabolism testing, and tests for environmental fate and ecotoxicity. However, these studies may not be the only means ofidentifying potential risks. SNUR notices submitted without accompanying test data may increase the likelihood that EPA would take action under TSCA section 5(e).

EPA encourages persons to consult with the Agency before submitting a SNUN forbenzidine-based chemical substances. As part ofthis optional prenotice consultation, EPA will discuss the test data itbelieves necessary to evaluate a significant new use ofthe chemical substances and advise in the selection ofa protocol for testing the chemical substances. Test data should be developed according to TSCA Good Laboratory Practice Standards at 40 CFR part 792. Failure to do so may lead EPA to find such data to be insufficient to reasonably evaluate thehealth or environmental effects ofthe chemical substances.

EPA urges SNUN submitters to provide detailed information on human exposure or environmental release that may result from the significant new use ofthe listed benzidine-based chemical substances. In addition, EPA encourages persons to submit information on potential benefits ofthe chemical substances and information on risks posed by the chemical substances compared to risks posed by potential substitutes.

X. Economic Analysis

EPA has evaluated the potential costs ofestablishing SNUR reporting requirements for the benzidine-based chemical substances listed in thisrule (Ref. 12). While there is no precise way to calculate the total annual cost of compliance with this rule, EPA estimates that the reporting cost for submitting a SNUN ranges from $7,198
to $8,170, including a $2,500 user fee. EPA believes that there will be few, if any, SNUNs submitted. Furthermore, while the expense ofa notice and the uncertainty ofpossible EPA regulation may discourage certain innovations, that impact would be limited because such factors are unlikely to discourage an innovation that hashigh potential value. The Agency's economic analysis is 

### available in the publicrecord for this rule (OPPTS-50617A).

XI. Rulemaking Record



### EPA has established a record forthis rulemaking (docket control number OPPTS-50617A). The record includes basic information considered by the Agency indeveloping this rule and the references listed in UnitXII ofthis preamble.

A public version ofthisrecord, without any Confidential Business Information is available forreviewing and copying from 12 noon to 4 p.m., Monday through Friday, except legal holidays, in the TSCA Nonconfidential Information Center (NCIC), located in Rm. NE-B607, 401 M St., SW., Washington, DC.
XII. References.

(1)International Agency for Research

on Cancer (IARC). IARC Monographs 1982,29,295-310,311-330,321-330).



### (2)IARCMonographs, Supplement 7:123-125 (1987).

(3)Rinde, E. and Troll,W. "Metabolic Reduction of Benzidine Azo Dyesto Benzidine inthe Rhesus Monkey." JournaloftheNationalCancer Institute 55:181-182 (1975).



### (4) National Cancer Institute (NCI). "13-week subcbronic toxicity studies of Direct Blue 6, Direct Black 38 and Direct Brown 95 dyes." NCI Carcinogenesis. Technical Report Series Number 108. 127p (1978).

(5)USEPA. Chemical Screening and Risk Assessment Division. Benzidine/ Benzidine Congener Dyes Support Document, Ocotber 24, 1994.

(6)ACGIH. American Conference of Government Industrial Hygienists, Inc. "Documentation ofthe Threshold Limit Values and Biological Exposure Indices. 6th ed." 121-122p (1991).

(7)Lynn,R.K. et al. "Metabolism of bisazobiphenyl dyes derived from benzidine, 3,3'-methylbenzidine and 3,3'-dimethoxybenzidine to carconogenic aromatic amines in the dog and rat." Toxicologyand Applied Pharmacology 56:248-2.58 (1980). (8)NIOSH/NCI, Current Intelligence Bulletin,24(1,5):7-9 (1978).

(9) IARC Monographs, Supplement 7:125-126 (1987).

(10) NIOSH, Special Occupational 

### Hazard Review for Benzidine-Based Dyes (1980).

(11) USEPA. 1990a (April). U.S. Environmental Protection Agency. Textile Dye Weighing Monitoring Study. EPA 560/5-90-009 and Supplement 560/5-90-010.

(12) USEPA. Regulatory impact Branch, USEPA/OPPT/EETD, June 1, 1993. "Production, Uses, and Imports of

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### 52294 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

Benzidine Based Chemicals." Prepared by Meridian Research, Inc.

(13) USEPA. Regulatory Impacts Branch, Economics, Exposure, and Technology Division. "Economic Analysis to Support the Proposed SNUR for Benzidine and Benzidine-based Dyes". May 12, 1995.
XIII. Regulatory Assessment Requirements

A. ExecutiveOrder12866

Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has been determined thatthis rule is not "significant" and is therefore not subject
to OMB review.

B.RegulatoryFlexibility Act
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), EPAcertifies thatthis rule will nothave a significant impact on a substantial number ofsmall entities. This certification can be found in the docket for this rule (OPPTS50617A). EPA has analyzed the impact ofthe rule on small entities based upon the criteria inthe Regulatory Flexibility Act. Unit XIII.C. ofthis preamble and the Economic Analysis (Ref. 13) to support this SNUR (docket number OPPTS-50617A) describe theburden and costs ofcompliance ofthisrule as well as the potential impacts on small entities.

This SNUR applies to any small or large business that may wish to engage in the significant new use described in the rule. It appears that no small or large businesses are currently engaged in activity that is the subject ofthis rule. Although there may be some small businesses that may decide to conduct such activities in the future, it is not possible at this time to determine for certain how many, ifany, there may be. Based upon past experiences, EPA expects to receive few, ifany SNUNs from either small or large businesses in response to this SNUR. To date, the Agency has received less than 10 SNUNs inresponse to the many SNURs promulgated by EPA in the past.

There are no existing Federal rules that may duplicate, overlap, or conflict with this rule. Finally there are no significant alternatives to this rule that minimize economic impacts on small businesses and accomplish the statutory objective ofinsuring that EPA has an opportunity to review and evaluate the risks associated with anew use to determine whether further regulatory activity is necessary.

Information relating to this determination may be provided to the Chief Counsel for Advocacy ofthe Small Business Administration upon request, 

### and is included in the docket for this rulemaking. Any comments regarding the economic impacts that this regulatory action may impose on small entities should be submitted to the Agency at theaddress listed above.

C. UnfundedMandateReformAct



### This rule is not subject to the requirements ofthe Unfunded Mandates Reform Act of 1995 (UMRA) (Pub.L. 104-4)because thisrule doesnot contain regulatory requirements that might significantly or uniquely affect small governments and does not contain

a Federal mandate that may result in expenditures of$100 million or more for State, local, and tribal governments, inthe aggregate, orthe private sector in any one year. Since no current ongoing manufacture, import, orprocessing of the listed benzidine-based chemical substance have been identified except foruses of such substances as areagent to test forhydrogen peroxide inmilk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain inmicroscopy; areagent for detecting blood; an analytical standard; orthe use ofC.I. Direct Red 28 as an indicator dye, this rule will not affect state, local, tribal governments, orthe private sector.EPA expects to receive few, ifany, SNUNs in response to this SNUR.

D.Executive Order12898



### Pursuant toExecutive Order 12898 (59 FR 7629, February 16, 1994), entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, the Agency has considered environmental justice related issues with regard to the potential impacts of this action on the environmental and health conditions in low-income and minority communities and does not expect any negative impacts since no current ongoing manufacture, import, or processing ofthelisted benzidine-based chemical substances were identified except for uses of such substances as a reagent to test forhydrogen peroxide in milk; a reagent to testfor hydrogen sulfate, hydrogen cyanide, and nicotine;

a stain in microscopy; a reagent for detecting blood; an analytical standard;

orthe use ofC.I. Direct Red 28 asan indicator dye. Additionally, EPA expects to receive few, ifany, SNUNs in response to this SNUR.

E.Submission to Congressandthe General Accounting Office 

### Under section 801(a)(1) (A) ofthe Administrative Procedure Act (APA) (5 U.S.C. 801) EPA submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House ofRepresentatives and the Comptroller General ofthe General Accounting Office prior to publication ofthisrule in theFederal Register. This rule is not a "major rule" as defined by 5 U.S.C. 804(2) ofthe APA as amended.

F.Paperwork ReductionAct
The information collection requirements contained in thisrule have already been approved by the Office of Management and Budget (OMB) under the provisions ofthe Paperwork Reduction Act (44 U.S.C. 3501 etseq.). This activity falls under OMB control number 2070-0038 (EPAICR No. 1188), which covers the submission ofSNUNs related to existing chemicals. Specifically, persons subject to this SNUR must submit a SNUN to EPA at least 90 days before manufacturing, importing, orprocessing a chemical substance for any significant new use (15 U.S.C. 2604(a)(1)(B)). The SNUN allows EPA to review and evaluate the intended use and prohibit orlimit that

use ifthe degree ofpotential health risk is sufficient to warrant such regulation. Persons subject to this SNUR would comply with the same notice requirements and EPA regulatory procedures as submitters ofPMNs under section 5(a)(1)(A) ofTSCA (15 U.S.C.2604(a)(1)(A)).

Additionally, persons who intend to export a chemical substance identified in the final SNUR are subject to TSCA section 12(b) (U.S.C. 2611(b) and 40 CFRpart 707). Persons who intend to import a chemical substance identified in the final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and to the regulations codified at 19 CFR 12.118 through 12.127 and 12.128. The EPA policy in support ofimport certification appears at 40 CFR part 707. OMB has already approved these activities under OMB Control No. 2070- 0030 (EPA#795). EPA must withhold from disclosure trade secret or confidential financial or commercial information submitted under TSCA.

In submitting a SNUN, the public reporting burden forthis collection of information is estimated to vary from 94
to 113 hours per response, with an average of 103 hours per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the collection ofinformation. These hours are included and accounted forin the above-referenced existing ICR.

Burden meansthe total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose

orprovide information to or for a

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### Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations 52295

Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel tobe able
to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection ofinformation unless it displays acurrently valid OMB control number. EPA is also amending the table ofcurrently approved information collection requests (ICR) control numbers issued by OMB for various regulations, which appears at40 CFR part 9. This amendment updates the table to accurately display OMB approval ofthe information requirements contained in this final rule. The display ofthe OMB control number in this notice and its subsequent codification in the Code of Federal Regulations satisfies the requirements ofthe Paperwork Reduction Act (44U.S.C. 3501 etseq.) and OMB's implementing regulations at 5 CFR part 1320. The ICR was previously subject to public notice and comment prior to OMB approval. As a result, EPA finds that there is "good cause" under section 553(b)(B) ofthe Administrative Procedure Act (5 U.S.C. 553(b)(B)) to amend this table without additional notice and comment. Due to the technical nature ofthe table, further notice and comment would be
unnecessary.

Send comments on the burden estimates and any suggested methods 

### for minimizing respondent burden, including through the use ofautomated collection techniques to Chief, Information Policy Branch (2131), U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC20460; and to the Office ofInformation and Regulatory Affairs, Office of Management and Budget, 725 17th St., NW., Washington, DC 20503, marked 

### "Attention: Desk Officer for EPA." The ICR number mustbe included in any correspondence.
List ofSubjects

40 CFRPart 9 

### Reporting and recordkeeping requirements.

40 CFRPart721



### Environmental Protection, Chemicals, Hazardous materials, Recordkeeping and reporting requirements, Significant

new uses.

Dated: September 26, 1996.
Charles M. Auer, Director,ChemicalControl Division,Office of

PollutionPrevention andToxics.
Therefore, 40 CFRparts 9 and 721 are 

### amended toread as follows:

PART 9-OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

1.The authority citation forpart 9 continues toread as follows:

Authority: 7 U.S.C. 135 etseq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1321, 1326, 1330, 1344, 1345 (d)and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 etseq., 6901-6992k, 7401- 7671q,7542, 9601-9657,11023,11048. 2. Section 9.1 is amended by adding the following new entry to the table in numerical sequence to read as follows:
§ 9.1 0MB approvals under the Paperwork Reduction Act.

40 CFR citation OMB control no.

721.1660

......................... 2070-0038

PART 721 -SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

3. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607 and 2625(e).

4. By adding new §721.1660 to subpart E to read as follows:
§721.1660 Benzidine-based chemical substances.

(a) Chemicalsubstancesand significantnew usessubjectto reporting. (1) Thebenzidine-based chemical substances listed intable 1 ofthis section are subject to reporting under this section for the significant new uses described inparagraph (a)(2) ofthis section.

(2) The significant new uses are any
use otherthan as areagent totest for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; areagent for detecting blood; an analytical standard; and also for Colour Index (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58-0) as an indicator dye.



### (b)Listofsubstances.The following table 1 lists the benzidine-based chemical substances covered by this section.



### Table 1.-Benzidine-Based Chemical Substances

CAS number C.I. name C.I. number Chemical Name

Benzidine Benzidine *

### 2HCL C.I. Direct Red 28

C.I. Direct Black 38

C.I. Direct Red 44

C.I. Direct Blue 2 N/A N/A 22120

30235

22500

22590 [1,1'-Biphenyl]-4,4'-diamine [1 ,1'-Biphenyl]-4,4'-diamine, dihydrochloride 1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-

4,4'-diylbis(azo)]bis[4-amino-, disodium salt 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,

4-diaminophenyl)azo][1,1 '-biphenyl]-4-yflazo]-5- hydroxy-6-(phenylazo)-, disodium salt 1-Naphthalenesulfonic acid, 8,8'-[[1,1'-biphenyl]

-4,4'-diylbis(azo)]bis[7-hydroxy-, disodium salt 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-

[(7-amino-l-hydroxy-3-sulfo-2-naphthalenyl)azo] [1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt 92-87-5 531-85-1 573-58-0

1937-37-7

2302-97-8

2429-73-4

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### 52296 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

Table 1.-Benzidine-Based Chemical Substances-Continued

CAS number C.1. name C.I. number Chemical Name

2429-79-0

2429-81-4

2429-82-5

2429-83-6

2429-84-7

2586-58-5

2602-46-2

2893-80-3

3530-19-6

3567-65-5

3626-28-6

3811-71-0

4335-09-5

6358-80-1

6360-29-8

6360-54-9

8014-91-3

16071-86-6 

### C.I. Direct Orange 8

C.I. Direct Brown 31

C.I. Direct Brown 2

C.I. Direct Black 4

C.l. Direct Red 1

C.I. Direct Brown 1:2

C.I. Direct Blue 6

C.l. Direct Brown 6

C.I. Direct Red 37

C.I. Acid Red 85

C.I. Direct Green 1

C.l. Direct Brown 1

C.I. Direct Green 6

C.I. Acid Black 94

C.l. Direct Brown 27

C.l. Direct Brown 154

C.1. Direct Brown 74

C.I. Direct Brown 95 22130

35660

22311

30245

22310

30110

22610

30140

22240

22245

30280

30045

30295

30336

31725

30120

36300

30145 Benzoic acid, 5-[[4'-[(1 -amino-4-sulfo-2- naphthalenyl)azol[1,1'-biphenyl]-4-yl]azo]-2- hydroxy-, disodium salt Benzoic acid, 5-[[4'-[[2,6-diamino-3-[[8-hydroxy3,6-disulfo-7-[(4-sulfo-l-naphthalenyl)azo]-2- naphthalenyl]azo]-5-methylphenyl]azo][1,1'- biphenyl]-4-yl]azo]-2-hydroxy-, tetrasodium salt Benzoic acid, 5-[[4'-[(7-amino-l-hydroxy-3-sulfo-

2-naphthalenyl)azo][1,1 '-biphenyl]-4-yl]azo]-2- hydroxy-, disodium salt 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-

[(2,4-diamino-5-methylphenyl)azo][1 ,1'- biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt Benzoic acid, 5-[[4'-[(2-amino-8-hydroxy-6-sulfo1 -naphthalenyl)azo][1,1 '-biphenyl]-4-yl]azo]-2- hydroxy-, disodium salt Benzoic acid, 5-[[4'-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 2,7-Naphthalenedisulfonic acid, 3,3'-[[1, 1'-

biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4- hydroxy-,tetrasodium salt Benzoic acid, 5-[[4'-[[2,4-dihydroxy-3-

[(4-sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-ethoxy

phenyl)azo][1,1 '-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt 1,3-Naphthalenedisulfonic. acid, 7-hydroxy-8-

[[4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl] azo][1 ,l'-biphenyl]-4-yl]azo]-, disodium salt 2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1 '- biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt Benzoic acid, 5-[[4'-[[2,4-diamino-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4-yl] azo]-2-hydroxy-, disodium salt 2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'- biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt 2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-3-[[4'-[[4-hydroxy-2-[(2-methylphenyl) amino]phenyl]azo][1,1 '-biphenyl]-4-yl]azo]-6-[(4- sulfophenyl)azo]-, trisodium salt Benzoic acid, 5-[[4'-[[4-[(4-amino-7-sulfo-1

-

naphthalenyl)azo]-6-sulfo-1 -naphthalenyl]azo] [1,1 '-biphenyl]-4-yl]azo]-2-hydroxy-, trisodium salt Benzoic acid, 5-[[4'-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4-yl] azo]-2-hydroxy-3-methyl-, disodium salt Benzoic acid, 3,3'-[(3,7-disulfo-1,5-

naphthalenediyl)bis[azo(6-hydroxy-3,1- phenylene)azo[6(or7)-sulfo-4, 1- naphthalenediyl]azo[1,1 '-biphenyl]-4,4'- diylazo]]bis[6-hydroxy-, hexasodium salt Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy5-sulfophenyl)azo]phenyl]azo][1 ,1'-biphenyl] -4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium

HeinOnline -- 61 Fed. Reg. 52296 1996