# + 2

(,1 1/,1(

Citation: 69 Fed. Reg. 22402 2004

Content downloaded/printed from HeinOnline (http://heinonline.org) Thu Jul 22 11:57:14 2010

-- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from uncorrected OCR text.Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

4.3 Exception
[Revise 4.3 toreadasfollows:]

Some parcels may be successfully processed on BMC parcel sorters even though they do not conform to the general machinability criteria in 4.1. The manager, BMC Operations, USPS Headquarters (see G043 for address)
may authorize a mailer to enter such parcels asmachinable parcels rather than irregular parcels ifthe parcels are tested on BMC parcel sorters and prove to be machinable. Mailers who wish to have parcels tested for machinability on USPS parcel sorting machines must:

a. Submit a written request to BMC Operations. The request must list mailpiece characteristics for every shape, weight, and size to be considered. Ifthe letter requesting testing describes a mailpiece that falls within the specifications ofpieces that

were tested previously, the mailpiece will not be tested.

b. Describe mailpiece construction, parcel weight(s), estimated number of parcels to be mailed in the coming year, andpreparation level (e.g., destination BMC pallets).

c. Send 100 samples to the test facility designated by the manger, BMC Operations, at least 6 weeks prior to the first mailing date. The manager, BMC Operations, will recommend changes, to

ensure machinability, ofparcels that do
not qualify.

6.0 OUTSIDE PARCEL (NONMACHINABLE)
[Revise thefirstsentence to readas follows:]

An outside parcel is a parcel that exceeds any ofthe maximum dimensions for a machinable parcel.

G General Information

GO00 The USPS andMailing Standards

G040 InformationResources

G043 AddressList forCorrespondence

[Add the followingaddress:]BMC Operations, US Postal Service, 475 L'Enfant PLZ, SW., RM 7631, Washington, DC 20260-2806. We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

Neva R.Watson, Attorney,Legislative. [FR Dec. 04-9414 Filed 4-23-04; 8:45am]

BILLING CODE 7710-12-P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9 and 799
[OPPT-2003-0006; FRL-7312-2]

RIN 2070-AD42

InVitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Finalrule.

SUMMARY: EPA is promulgating a final rule under the Toxic Substances Control Act (TSCA)that requires manufacturers (including importers) andprocessors of 34 chemicals to conduct in vitro dermal absorption rate testing. These chemicals

are ofinterest to the Occupational Safety andHealth Administration (OSHA) ofthe Department ofLabor, and the data obtained under this testing
program will be used by OSHA to evaluate the need for "skin designations" for these chemicals. Skin designations are used by OSHA to alert industrial hygienists, employers, and workers to the potentially significant contribution to the overall exposure to certain chemicals which can occur by the cutaneous route. Thus, skin designations encourage employers to consider whether changes shouldbe made to processes involving such chemical substances in order to reduce the potential for systemic toxicity from dermal absorption ofthese chemicals. Persons who export orintend to export any chemical substance included in this final rule are subject to the export notification requirements in TSCA section 12(b).

DATES: This final rule is effective on May 26, 2004. For purposes ofjudicial review, this final rule shall be promulgated at 1p.m. eastern daylight/ standard time on May 10, 2004.

ADDRESSES: EPAhas established a docket for this action under docket identification (ID) number OPPT-2003- 0006. All documents in the docket are listed in the EDOCKET index athttp:/ /www.epa.gov/edocket/. Although listed in the index, some information isnot publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will notbe placed onthe Internet and willbe publicly available only in hard
copy form. Publicly available docket materials are available either electronically inEDOCKET or in hard
copy at the Office ofPollution Prevention and Toxics (OPPT) Docket, EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744, and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For generalinformationcontact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office ofPollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

Fortechnicalinformationcontact: Keith Cronin or Catherine Roman, Chemical Control Division (7405M), Office ofPollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8157 or (202) 564- 8172; e-mail address: cronin.keith@epa.gov or

roman. catherine@epa.gov.

SUPPLEMENTARY INFORMATION:
I. General Information

A. Does thisActionApply toMe?

You may be affected bythis actionif you manufacture (definedby statute to include import) or process any ofthe chemical substances that are listed in §799.5115(j) ofthe regulatory text. Any

use ofthe term "manufacture" in this document will encompass "import," unless otherwise stated. In addition, as described in Unit VI., any person who exports or intends to export any ofthe chemical substances in this final rule is subject to the export notification requirements in 40 CFR part 707, subpart D. Entities that could be subject
to the requirements in this final rule may include, but are not limited to:

* Manufacturers (definedby statute to include importers) ofone ormore of the 34 subject chemical substances 

### 22402

HeinOnline -- 69 Fed. Reg. 22402 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

(NAICS 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

* Processors ofone ormore ofthe 34 subject chemical substances (NAICS 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This listing isnot intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unitcould also be affected. The North American Industry Classification System (NAICS) codes have been provided to assistyou and others in determining whether this action might apply to certain entities. To determine whether you oryour business may be affected by this action, you should carefully examine the applicability provisions in Unit V.E. and consult the regulatory text at 40 CFR 799.5115(b). Ifyou have any questions regarding the applicability ofthis action
to a particular entity, consult one ofthe technical persons listed under FOR FURTHER INFORMATION CONTACT.

B. How CanIAccessElectronicCopies ofthisDocumentandOther Related Information?

In addition to EDOCKET (http:// www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the "Federal Register" listings at http://www.epa.gov/fedrgstr/.A frequently updated electronic version of 40 CFR part 9 and part 799 is available

onE-CFR Beta Site Two athttp:// www.gpoaccess.gov/ecfr/.

II. Background

A. WhatAction istheAgency Taking?

In this action, EPA is promulgating a test rule under TSCA section 4 (15 U.S.C. 2603) which responds to recommendations ofthe Interagency Testing Committee (ITC). Under TSCA section 4(e)(1), the ITC isresponsible for recommending chemical substances and mixtures to the EPA Administrator for priority testing consideration. In September 1991, the ITC received a nomination from OSHA of658 chemical substances and mixtures for ITC review. OSHArequested thatthe ITC assess the availability ofdata relevant to dermal absorption for these chemical substances and mixtures and determine the need for further testing (Ref. 1). OSHA indicated to the ITC that it needed quantitative measures ofdermal absorption to evaluate the potential hazard ofthese chemicals to workers (Ref.2). These quantitative measures are expressed as the dermal absorption rate for aparticular chemical (Ref.3, p. 35725). The results ofthe ITC's review were published in the Federal Register (Ref. 1, p. 26900 and Ref. 2,pp. 38492- 38493).

In the 31st, 3 2nd, and 3 5th ITC Reports
to the EPA Administrator (Refs. 1, 2, and 4), the ITC designated for in vitro dermal absorption rate testing a total of 83 ofthe 658 chemical substances nominated by OSHA. A summary ofthe process bywhich the ITC selected the 83 chemical substances was presented in the proposal to this action (Ref. 5,p. 31077). The data reviewed by the ITC included data obtained from TSCA section 8(a) and 8(d)rules (Refs. 6, 7, and 8) which were promulgated byEPA for the 83 chemical substances included in the 3 1 st, 3 2nd, and 3 5th ITC Reports (Refs. 1, 2, and 4). These rules required the reporting to EPA ofcertain production, use and exposure-related information, and unpublished health and safety data concerning the 83 chemical substances.

In reviewing the available data, the ITC determined that the data for methyl methacrylate, diethyl phthalate, and cyclohexanone would meet OSHA's data needs for these three chemicals. Accordingly, the ITC withdrew its designation for these three chemicals: Methyl methacrylate and diethyl phthalate in the 34thITC Report (Ref. 3), and cyclohexanone in the 36th ITC Report (Ref.9).

Eighty ofthe chemical substances originally nominated by OSHA are thus currently designated bythe ITC for in vitrodermal absorption rate testing under TSCA. In the Federal Register notices containing the 31st, 32nd, and

3 5 th ITC Reports (Refs. 1, 2, and4), EPA solicited proposals for TSCA section 4 enforceable consent agreements (ECAs) for dermal absorption rate testing ofthe 80 chemical substances. EPA received

no proposals for ECAs for dermal absorption rate testing in response to these solicitations. OnApril 3, 1996, EPA again solicited interested parties to submit proposals for ECAs (Ref. 10). On June 26, 1996, EPA received aproposal from the ARCO Chemical Company (ARCO) (Ref.11) for tert-butyl alcohol. On March 26, 1998, EPA received a study from ARCO entitled [14C]-t-ButylAlcohol: Topical Application:Dermal Absorption Study in theMaleRat(Refs. 12 and 12a.). This study was reviewed and found acceptable as ameans ofdetermining the dermal absorption rate for tert-butyl alcohol. Accordingly, EPA did not propose testing oftert-butyl alcohol. OnJune 9, 1999, EPA responded to the ITC's designation ofthe remaining 79 chemicals byissuing aproposed test rule under TSCA section4 (Ref. 5) which would require that47 ofthese chemical substances be tested with respect to in vitrodermal absorption
rate. The Agency selected the 47 chemicals fortesting because, at the time ofthe proposal, EPA believed that theirproduction volumes were the highest among the 80 chemicals designated by the ITC. At the time ofthe proposed rule, the most current information available to EPA indicated that each ofthe 47 chemicals was produced in "substantial quantities," meaning that their annual production volumes ranged from one million to

more than one billion pounds. These chemical substances were being used in

a widevariety ofapplications, which resulted inpotential exposures of 1,000

or more workers to each chemical substance. Based upon EPA's review of

more recent production volume data,
exposure data, and dermal absorption
rate data, which became available after the proposal to this rule was published, EPA is now requiring testing for 34 of the 47 chemicals that had been included in the proposed rule. The rationale for EPA's decision not to finalize testing requirements for the other 13 chemicals, which were originally proposed for testing, is described in Unit VII.A. through I.

EPA is requiring that the 34 chemicals be tested according to the in vitro dermal absorption rate test standard set forth in §799.5115(h) ofthe regulatory
text. EPAhas also specified reporting requirements in §799.5115(i) ofthe regulatory text. EPA may pursue testing ofthe remaining 32 chemicals based on further analysis.

In the solicitations discussed in this unit (Refs. 1, 2,4, and 10), EPA referenced an in vitro dermal absorption
rate testmethod for review bypotential submitters in developing their proposed protocols (Ref. 10, p. 14776). This method was based on the peer reviewed method ofBronaugh andCollier (Ref. 13). Some refinements ofthe method

were made by a panel ofFederal scientists from ITC member and liaison agencies (including,for example, Consumer Product Safety Commission (CPSC), Department ofDefense (DoD), EPA, Food and Drug Administration (FDA), National Institute for Occupational Safety and Health (NIOSH), and OSHA). EPA received public comments onthe method and entered them, along with the method itself,into the dockets for the 3 1 st, 3 2 nd, and 35th ITC Reports (docketcontrol numbers OPPTS-41038, OPPTS-41039, and OPPTS-41042, respectively). In addition, the American Chemistry Council (ACC, formerly the Chemical Manufacturers Association (CMA)) submitted aproposed protocol outlining 22403

HeinOnline -- 69 Fed. Reg. 22403 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

an alternative method (Refs. 14 and 14a.). Scientists from the Federal Agencies represented onthe ITC (includingEPA and OSHA) reviewed the public comments and the ACC proposal. As a result ofthis review, the ITC and EPA scientists further refined the in vitrodermal absorption rate test method ofBronaugh and Collier which EPA then proposed tobe the test standard required by this final rule (Ref. 5).
The test standard that willbe required under this final rule describes the procedures for measuring a permeability
constant (Kp) and two short-term absorption rates (10 minutes and 60 minutes) for chemical substances in liquid form. A Kp is useful in estimating skinpermeation when contact with the chemical is prolonged (hours)and steady state is achieved, while a shortterm absorption rate measurement is

more relevant when the contact is shortterm (minutes). Both measurements are required bythe test standard.

This test standard makes use of established in vitro diffusion cell techniques that allow absorption rate studies to be conducted using human cadaver skin and either flow-through or static diffusion cells (see §799.5115(h) in the regulatory text). This test standard also requires the use of radiolabeled chemical substances unless the test sponsor can demonstrate that procedures utilizing anon-radiolabeled
test substance are able to measure the substance with equivalent sensitivity. The first six parameters that are discussed under test procedures in §799.5115(h)(5) ofthe regulatory text (i.e., choice ofmembrane, preparation of membrane, diffusion cell design, temperature, testing ofhydrophobic chemicals, andvehicle) are similar for the determination ofeither ofthe two percutaneous absorption rate values (Kp and short-term absorption rate). In contrast, the remaining two parameters (i.e., dose and study duration) are different for the two percutaneous absorption ratevalues.

The in vitroapproach was chosen not onlyfor the practical considerations that it makes efficient use oflabor and materials and can easily be performed by a variety oflaboratories, but also because in vitro diffusion cell studies

are necessary for measuring a Kp. Although the in vitro method in §799.5115(h) ofthe regulatory text will satisfy OSHA's data needs to support its skin designations, EPA does not believe the method is an adequate substitute for all dermal absorption rate testing methods. B. What istheAgency'sAuthority for Taking thisAction?

This final rule isbeing promulgated under TSCA section4 (15 U.S.C. 2603), which authorizes EPA torequire the development of datarelevant to assessing the risk to health andthe environment posed by exposure to chemical substances andmixtures (chemicals).

Section 2(b)(1) ofTSCA (15 U.S.C. 2603(b)(1)) states that itis the policy of the United States that:

adequate data should be developed with respect tothe effect ofchemical substances and mixtures on health and the environment and that the development ofsuch data shouldbe theresponsibility ofthose who manufacture and thosewho process such chemical substances and mixtures[.]

To implement this policy, TSCA section 4(a) mandates that EPA require by rule that manufacturers and/or processors of chemical substances andmixtures conduct testing ifthe Administrator finds that:

(1)(A)(i) the manufacture, distribution in
commerce, processing, use, or disposal ofa chemical substance or mixture, orthat any combination of such activities, may present

an unreasonable risk ofinjury to health or the environment,

(ii)there are insufficient data and experience upon whichthe effects ofsuch manufacture, distribution in commerce, processing, use, or disposal ofsuch substance

ormixture orany combination of such activities on health or the environment can reasonably be determined orpredicted, and

(iii)testing ofsuch substance ormixture with respect to such effects is necessary to develop such data; or

(B)(i)a chemical substance or mixture is or will be produced in substantial quantities, and (I) itenters ormay reasonably be anticipated to enterthe environment in substantial quantities or (II) there is or may be significant or substantial human exposure to such substance ormixture,

(ii)there are insufficient data and experience upon whichthe effects ofthe manufacture, distribution in commerce, processing, use, or disposal ofsuch substance

ormixture orany combination of such activities on health or the environment can reasonably be determined orpredicted, and

(iii)testing ofsuch substance ormixture withrespect to such effects is necessary to develop such data [.]

The purpose ofthis testing is to develop data about the substance's or mixture's health or environmental effects for which there is an insufficiency of data and experience, and which are relevant to a determination that the manufacture, distribution in commerce, processing,
use, or disposal ofthe substance or mixture, or any combination of such activities, does or does not present an unreasonable risk ofinjury to health or the environment.

Once the Administrator has made a finding under TSCA section 4(a)(1)(A)(i) (i.e., a finding that a chemical substance
may present an unreasonable risk of injury to health or the environment) or

a finding under TSCA section 4(a)(1)(B)(i) (i.e., a finding that a chemical substance is or will be produced in substantial quantities and either it enters or may reasonably be anticipated to enter the environment in substantial quantities or there is ormay be significant or substantial human
exposure to the chemical substance), EPA may require any type ofhealth or environmental effecttesting necessary to address unanswered questions about the effects ofthe chemical substance. EPA need notlimit the scope oftesting required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA also finds that there are insufficient data and experience upon which to reasonably predict the effects ofthe manufacture, distribution in commerce, processing,

use, or disposal ofsuch substance or mixture or any combination ofsuch activities onhealth or the environment, and that testing is necessary to develop such data. This approach is explained in

more detail in EPA's statement ofpolicy for making findings under TSCA section 4(a)(1)(B) (frequently described as the "B" policy) (Ref. 55, pp. 28738-28739).

In this final rule, EPA isusing its broad TSCA section 4(a) authority to obtain dermal absorption rate data
necessary for OSHA to evaluate the need for "skin designations" (see Unit III.B.3.) for the 34 chemical substances specified in Table 2in §799.5115(j) of the regulatory text. Following consideration ofthe public comments received by EPA on the proposed test rule (Ref.5), EPA is making the following findings for these chemicals underTSCA section 4(a)(1)(B): They are produced in substantial quantities; there is or may be substantial human
exposure to them; existing data are insufficient to determine or predict their health effects; and testing is necessary to develop such data.

EPA has used its TSCA section 4(a) authority in the past to support regulatory programs of other EPA offices

as well as other Federal Agencies needing health and/or environmental effects test data. See, e.g., the final test rule forthe Office ofWater Chemicals (Ref.68, p. 59673). 22404

HeinOnline -- 69 Fed. Reg. 22404 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

III. Response to Public Comments

A. Summary

EPA received comments on the proposed rule (Ref.5)from ACC, Monsanto Company, First Chemical Corporation, American Forest and Paper Association (AFPA), American Petroleum Institute (API), Biphenyl Work Group, Diethyl Ether Producers Association (DEPA), Synthetic Organic Chemical Manufacturers Association (SOCMA), Acetonitrile Task Force, Dupont DowElastomers, Fragranced Products Information Network, Association ofVeterinarians for Animal Rights, People for the Ethical Treatment ofAnimals, Animal Protection Institute Midwest Regional Office, Humane Society ofthe United States, Doris Day Animal League, Chlorobenzene Producers Association, Tetrahydrofuran Task Force (THFTF), a private citizen, and Union Carbide Corporation (Refs. 15-33).

ACC's Naphthalene Panel, Propylene Glycol Ethers Panel, Olefins Panel (ACC/O), Hydrocarbon Solvents Panel, Ketones Panel and Oxo Process Panel (ACC/KO), and Carbon Disulfide Panel, generally supported the comments by ACC (Refs. 34-39). The Chlorobenzene Producers Association, Biphenyl Work Group, and the Acetonitrile Task Force, also endorsed the comments submitted by ACC. Comments by ACC and those
comments generally supportive of ACC's comments are collectively referred to as "ACC's" hereinafter in this document. Comments submitted by these groups that are specific to a chemical are addressed, as appropriate, in Unit III.F. and in Unit VII.

A summary ofthe comments received by EPA on the Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to Occupational Safety andHealth Administration is included in this unit, along with EPA's responses to those
comments. The comments are available in the public docket for this rulemaking (see ADDRESSES).

B. TSCA Section4 Findings
1. "Substantial" humanexposure, TSCA section4(a)(1)(B)(i)(II)-a. "B" policy.ACC commented that EPAhas
not provided a sufficient basis for its finding of "substantial" human exposure under TSCA section 4(a)(1)(B)(i)(II), (15 U.S.C. 2603(a)(1)(B)(i)(II)), with its approach in this final rule which is based solely on numbers ofpeople exposed (more specifically, the number ofworkers exposed) to each chemical. ACC asserts that a substantial human exposure finding must additionally be based on information such as each chemical's physical, chemical, and biological properties; the manner ofuse and release; exposure concentrations; and duration andfrequency ofexposure. ACC states that neither OSHA's objective of developing skin designations, nor EPA's objectives under TSCA, are served by requiring dermal testing in circumstances where dermal exposures are at low concentrations, or are so infrequent that harm is not likely to occur.

EPA disagrees with ACC's assertion that EPAhas not provided a sufficient rationale for its finding that there is or may be "substantial" human exposure to the chemical substances that are subject to this final rule as required under TSCA section 4(a)(1)(B)(i)(II). EPA also disagrees with ACC's contention that EPA must consider chemical-specific factors to make a "substantial" human exposure finding. In its policy statement that explains how EPA generally makes findings under TSCA section 4(a)(1)(B)(i) (the "B" policy), EPA articulated quantitative thresholds to serve as guidance in making findings of "substantial" production, release, and human exposure. (Ref.55) These quantitative thresholds are based onthe Agency's beliefthat it is reasonable to interpret the word "substantial" to

mean exposure to large numbers of people. Therefore, EPA believes that, in the case ofthis final rule, where, based

oninformation available to EPA (Refs. 5 and 56), 1,000 ormore workers are potentially exposed to each chemical for which the final rule would require testing, itis reasonable to require the testing ofeach chemical. In other words, EPA's policy (as articulated in its final "B" policy statement (Ref. 55)) is that quantitative data alone canjustify EPA's finding thatproduction, potential release, or the number ofpeople potentially exposed to a chemical are "substantial." This is consistent with TSCA's goals ofensuring that, given the
exposure ofhumans andthe environment to alarge number of chemical substances andmixtures with potentially harmful effects, there is effective regulation ofcommerce in such substances (15 U.S.C. 2601(a)), that adequate data be developed with respect to the effect ofchemical substances and mixtures onhealth and the environment, andthat the development ofsuch data should be the responsibility ofthose who manufacture and those who process these substances (15 U.S.C. 2601(b)). Affected entities had the opportunity to comment on the proposed rule and submit current employee information, readily available
to them, to refute EPA's finding that a substantial number ofemployees is exposed. In those instances when EPA agreed with information submitted by
commenters which demonstrated that fewer than 1,000 employees were exposed to a chemical, that chemical

was not included in thisfinal rule (see UnitVIID., E., andG.)

A "substantial" human exposure finding under TSCA section 4(a)(1)(B)(i)(II) requires nohazard or risk analysis (Ref.55, p. 28742). Giventhe statutory framework, the legislative history, andthe case law interpreting the TSCA section 4 testing provisions, EPA does notbelieve that itis required
to consider each ofthe types of information described by ACC in order
to make a TSCA section 4(a)(1)(B)(i)(II) "substantial" human exposure finding (Ref.55, p. 28742).

Although EPA is not required to consider the factors mentioned byACC in making its "substantial" human
exposure findings, information ofthe
sort described by ACC is nevertheless relevant to other decisions leading to a determination as to whether to require testing underTSCA section 4.As stated in the Agency's "B" policy:

[f]or each substance-specific rulemaking under section 4, EPAmust determine whether there are sufficient 'data and experience' upon which to 'reasonably determine or predict' thehealth and environmental effects ofachemical substance, and whethertesting of such substance is 'necessary to develop such data.' Inmaking these determinations, the Agency has always, and will continue to examine all available andrelevant information concerning the substance inquestion, includingthe physical andbiological properties of the substance, themanner ofits

use and release, the level, frequency, and duration ofexposure, and anyavailable relevant exposure and toxicity data.It isthe responsibility ofinterestedparties toprovide anyinformation theybelieve maybe relevant tothe Agency's determination to require testingof aparticular chemical substance under TSCA section 4. (Ref.55, p. 28743).

In those instances where interested parties provided such relevant information on chemical substances prior to the publication ofthis final test rule, EPA and OSHA carefully reviewed the information and, based on that review,EPA in some cases decided not to require testing for those chemical substances. (See Unit VII.A. through G.).

b. TheNationalOccupational ExposureSurvey (NOES).ACC commented that EPA has continued to rely on the NOES database to support its findings of "substantial" human
exposure, a data base which ACC

### 22405

HeinOnline -- 69 Fed. Reg. 22405 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

believes to be unrepresentative, incomplete, and outdated. ACC states that the NOES estimates are greatly overstated and should not be relied
upon by EPA in making its findings. ACC provided a critique ofthe NOES (Ref.40) as support for its statements and added that EPA should evaluate the level, frequency, and duration of
exposure to each chemical to determine ifitis "substantial."

EPA disagrees with the commenter's
statements regarding the adequacy of the NOES for supporting a finding of "substantial" human exposure under TSCA section 4(a)(1)(B)(i)(II). This database contains, among other things, useful information on the approximate number ofworkers potentially exposed
to a chemical substance specified in the database. That is to say, while the survey does not provide meaningful information on the level, frequency, or duration ofexposure, it is useful for providing an estimate ofthe potential number ofworkers exposed to a chemical. As noted in Unit III.B.1.a., EPA also does not agree with the
comment that EPA shouldundertake an exhaustive analysis ofexposure (i.e., level, frequency, and duration) to a chemical substance to find that there is

ormay be "substantial" human
exposure.

For each ofthe chemicals for which testing is required in this final rule, estimates ofthe number ofexposed workers were identified in the NOES. The NOES was a nationwide data gathering project conducted by NIOSH, which was designed to develop national estimates for the number ofworkers potentially exposed to various chemical, physical, and biological agents and describe the distribution ofthose potential exposures. Initiated in 1980 and completed in 1983, the survey involved a walkthrough investigation by trained surveyors of4,490 facilities in 523 different types ofindustries. Surveyors recorded potential exposures when a chemical agent was likely to enter or contact aworker's body for a minimum duration. These potential
exposures could be observed or inferred. Information from these representative facilities was extrapolated to generate national estimates ofpotentially exposed workers for more than 10,000 different chemicals (Ref.41). The NOES
survey is the most recent and comprehensive source ofthis kind of information.

In the critique ofthe NOES cited by ACC, ageneral conclusion ofthe authors was:

We conclude from reviewing the survey design that,despite some flaws, it represents one ofthe soundest approaches possible, within the limitedbudget, for attaining national estimates ofthenumber ofworkers in the proximity ofpotentially hazardous agents. (Ref.40).
EPA agrees with this conclusion and believes that itis reasonable to use information provided in the NOES database to support afinding of "substantial" human exposure for a chemical substance contained within that database.

In addition,EPA agrees with the authors ofthe critique, Buell et al (Ref. 40), that the surveyresults, while potentially useful for making broad, national estimates ofthe number of
persons in workplaces where potentially hazardous agents are also present, shouldnot be used to gauge actual worker exposure to these agents, particularly to individual chemicals in individual industry sectors. This information was not collected in the survey. EPAhas relied only onthe information in the NOES database regarding the approximate number of potentially exposed workers in support ofits finding of"substantial" human
exposure.

Because some time has passed since the NOES was completed, EPA acknowledges that there may be instances where changes in various industrial sectors (i.e., market demand, advances in technology, and other mitigating factors) have led to a decrease in the number ofworkers potentially exposed to certain chemical substances. EPA's proposed test rule asked interested parties to provide any information they believed relevant to the Agency's determination to require testing ofa particular chemical substance under TSCA section4. EPA has received additional exposure information on certain chemical substances for which testing was proposed. This information has been fully considered, and for those chemical substances for which EPAbelieves it
cannot make the "substantial" human
exposure finding in light ofsuch information, the Agency is not finalizing testing requirements. (See Units VIID., E., and G.).

c. The ToxicReleaseInventory(TRI). ACC stated that it is unclear what role the TRI dataplayed in making the TSCA section4 findings in the proposed rule, and that EPA should clarifyhow environmental releases factor into a determination ofoccupational dermal
exposures. ACC notes that TSCA section 4(a)(1)(B), makes no mention of "release," but refers to whether a substance "enters" the environment. ACC asserts that in the context ofTSCA section 4, the word "enter" connotes presence in the environment. Accordingly, ACC argues that "release" ofa chemical in excess of one million pounds per year is notnecessarily evidence thatthe compound "enters" the environment in "substantial" quantities. For example, ifa substance is dispersed, degraded, or reacted rapidly upon release from manufacturing andprocessing facilities and is never present in significant concentrations in air, water, or soil, ACC asserts that it has not "entered" the environment in "substantial" quantities.

Moreover, ACC contends that environmental release, such as that reported under section 313 ofthe Emergency Planning and Community Right-to-Know Act (EPCRA), does not correlate well with dermal exposure in the workplace. ACC notes that TRI reports do not indicate the concentrations oflisted substances in environmental media or the extent of their distribution in the environment. Accordingly, ACC asserts that the release quantities reported under section 313 ofEPCRA are not an adequate basis to support a TSCA section 4(a)(1)(B)(i)(I) finding in the
context ofthis final rule, and they should notbe combined with other data

on the number ofworkers potentially exposed to support such a finding.

Although EPA reviewed information contained in the TRI database to identify additional support material for the test rule (Ref. 56), EPA did not find itnecessary to use TRI release data in developing its exposure findings for this final rule.

d. TSCA sections8(a)and8(d). API commented that EPA does not present results ofdata gathering in the 1993, 1994, and 1995 TSCA section 8(a) and 8(d) rules (Refs. 6-8) for the proposed
test rule chemicals. API objects to EPA's issuing data gathering rules and then
notusing the data gathered for the
purposes ofthe testrule, particularly given that itis 10years more current thanthe data that EPA used to make its TSCA section 4(a)(1)(B)(i)(II) finding i.e., NOES data (Ref.19).

Following the EPA Administrator's receipt ofthe ITC Reports (Refs. 1, 2, and 4) which designated 83 chemicals for priority testing, the EPA's Office of Pollution Prevention and Toxics (OPPT) promulgated TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) and TSCA section 8(d) Health and Safety Data rules (Refs. 6-8) for the 83 chemicals designated for testingby the ITC. The TSCA section 8(a) rule required manufacturers and importers of chemicals designated for testingby the ITC to submitproduction 22406

HeinOnline -- 69 Fed. Reg. 22406 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

and exposure reports. The TSCA section 8(d)rule required manufacturers (including importers), and processors of chemicals designated for testing by the ITC to submit unpublished health and safety studies. These rules are automatically promulgated by EPA unless the ITC requests that EPA not do SO.

The ITC reviews the TSCA section 8(a)PAIR reports, TSCA section 8(d) studies, and "other information" that become available after the ITC adds chemicals to the PriorityTestingList. "Other information" includes TSCA section 4(a) studies, TSCA section 8(c) submissions, TSCA 8(e) "substantial risk" notices, "For Your Information" (FYI) submissions, ITC-FYI voluntary submissions, unpublished data submitted to U.S. Government organizations represented onthe ITC, published papers, as well as use, exposure, effects, andpersistence data that are voluntarily submitted to the ITC by manufacturers, importers, processors, and users ofchemicals recommended by the ITC. The submissions are indexed and maintained byEPA. After the ITC reviews this information it determines if data needs shouldbe revised, if chemicals shouldbe removed from the PriorityTestingList, orif recommendations should be changed to designations.

EPA disagrees with the comment that data gathered under TSCA section 8(a) and 8(d)rules were not considered in preparing the proposal. In fact, the proposed rule described the ITC's use of the data from the TSCA section 8(d) rules to support withdrawing its designation for three chemicals. As described in the proposal (Ref. 5,p. 31077), the ITC received dermal absorption rate data for three chemicals after EPA had promulgated TSCA section 8(d)rules for these chemicals. The ITC determined that the dermal absorption rate data for these three chemicals would meet OSHA's data needs, and accordingly, the ITC withdrew its designation for these three chemicals: Methyl methacrylate and diethyl phthalate in the 34th ITC Report (Ref.3, p. 35725), and cyclohexanone in the 3 6 th ITC Report (Ref.9, p. 42987).

Furthermore, the ITC's review ofthe data gathered under TSCA sections 8(a) and 8(d)for the 80 remaining designated chemicals did not provide a sufficient rationale for the ITC to make a determination that the specified data needs shouldbe revised or that its designation ofchemicals for in vitro dermal absorption rate testing should be withdrawn and those chemicals removed from itsPriorityTestingList. The proposed rule also described EPA's use ofproduction data as abasis for its decision to pursue rulemaking on only47 ofthe remaining 80 designated chemicals because oftheir greater production volumes, data which were reported under the TSCA section 8(a) rules (Ref.5, p. 31077). Although EPA considered the information on employee
exposure atmanufacturing sites provided in the TSCA section 8(a) submissions, EPA also relied onNOES data asthey indicate what additional employee exposure may occur at processing facilities.

Finally, for those remaining 32 chemicals designated for in vitro dermal absorption rate testing bythe ITC which

are not addressed by this final rule, EPA will present any determinations regarding data gathered from TSCA section 8(a) and 8(d), as well as any other available data in any future proposal for those chemicals. 2. "Dataareinsufficient," TSCA 4(a)(1)(B)(ii).DEPA (Ref. 21), the Chlorobenzene Producers Association (Ref.31), and the Union Carbide Corporation (Ref.47) challenged the Agency's finding that data are insufficient to determine a dermal absorption rate for ethyl ether, odichlorobenzene, andn-amyl acetate, respectively. These commenters provided studies to support their claims that available data are sufficient to determine dermal absorption rates. ACC (Ref.15) commented that isobutyl alcohol and sec-butyl alcohol are structurally similar to other alcohols for which data have been generated and that a structure-activity relationship (SAR) approach could be used to predict the dermal absorption rates ofthese two chemicals. EPAreviewed the submitted studies and agreed that the available data are sufficient at this time to adequately determine orpredict dermal absorption rates for these five chemicals. See Unit VII.A. through C. and F. for a description ofthe submitted studies andthe basis for EPA's decision
not to pursue rulemaking onthese five chemicals.

3. "Testingisnecessary," TSCA section4(a)(1)(B)(iii).ACC commented that EPA failed to demonstrate that the proposed testingis necessary to develop data to predict the effects ofthe chemicals onhuman health andthe environment (Ref. 15). ACC also stated that the Agency has provided no information on the need for dermal absorption data to "support chemical risk assessments at EPA aswell as at otherFederal agencies." As ageneral matter, ACC believes that EPA should
not require testing when the Agency has
not determined how the data will be used, and indeed cannot conclude that testing is necessary in such a case. Similarly, API and THFTF (Refs. 19 and 32) requested that EPA explain howthe Agency (or other Federal Agencies) might use the dermal test data.

EPA believes it has adequately demonstrated a need for the testing that willbe conducted under this final rule. As discussed in the preamble to the proposed rule (Ref.5, pp. 31076-31078) and inthe 3 1 st, 3 2nd, and 3 5 th ITC Reports to the Administrator (Refs. 1, 2, and 4,respectively), OSHA has found that for many toxic substances to which workers are exposed via multiple routes, and specifically forthe chemical substances for which testing will be required under this final rule, very little knowledge exists ofthe contribution of dermal exposure to the total body burden ofthe substance.

Dermal absorption rate data for toxic substances encountered inindustrial and occupational settings are quantitative estimates ofthe rate (amount per specified period oftime) at which substances pass throughthe layers ofthe skin to enter the systemic circulation. OSHA assigns a "skin designation" to a chemical ifit determines that cutaneous exposure (through the skin, eyes, andmucous membranes) to the chemical may result in systemic toxicity. In order to assign

a skin designation for a chemical substance, OSHA requires dermal absorption rate data. OSHA requested (Refs. 1, 2,and 4) that the ITC help identify chemicals which lack sufficient data for OSHAto develop skin designations and to use its authority to recommend chemicals for priority testing consideration by EPA to obtain these data.

As described inthe proposed rule, the ITC performed searches for data relating
to the chemicals onthe following databases: RTECS (Registry ofToxic Effects ofChemical Substances), TOXLINE (TOXicology ofinformation onLINE), MEDLINE (MEDlars onLINE), TOXLIT (TOXicology LITerature from special sources), CECATS (OPPT/Risk Assessment Division/Chemical Screening Branch's Existing Chemical Assessment Tracking System), TSCATS (Toxic Substances Control Act Test Submissions), and INDEX MEDICUS. The search strategy was designed to identify any toxicological teststhat used the dermal route ofexposure. The information from the searches was collected andthe chemicals were subcategorized based on the number of postings (Ref.2, p. 38493).

Also as described inthe proposed rule, in addition to these literature searches, the ITC reviewed data from 

### 22407

HeinOnline -- 69 Fed. Reg. 22407 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

TSCA section 8(a) and 8(d) rules (Refs. 6 through 8) which were promulgated by EPA for the chemical substances included in the 31st, 3 2 nd, and 3 5thITC Reports (Refs. 1, 2, and 4). These rules required the reporting to EPA ofcertain production, use and exposure-related information, and unpublished health and safety data concerning these chemicals. Forthe 34 chemicals for which in vitrodermal absorption rate testing is required under this final rule, there was either no dermal absorption
rate information available or available data were insufficient to derive a dermal absorption rate.

Testing ofthe 34 subject chemical substances is necessary to develop dermal absorption rate data. Dermal absorption rate data derived from testing these 34 chemical substances are needed byOSHA to estimate the
amount ofthe chemical substance absorbed after contact with the skin. Only when dermal absorption is considered along with inhalation
exposure data can a more complete and
accurate quantitative assessment of body burden be estimated. Accurate estimates ofbody burden are necessary to develop assessments ofrisk to worker health posed by exposures to toxic substances in the workplace. This testing is needed to determine ifthe manufacturing, processing, or use of these 34 chemical substances presents

an unreasonable risk ofinjury to human health.

In addition toplaying an important role in assessing body burden, dermal absorption rate data can generate useful quantitative information for making recommendations or decisions concerning engineering controls or employee use ofpersonal protective clothing to prevent exposure by the dermal route. Such information, when considered in conjunction with toxicologic and health effects data, can be used by industrial hygienists, other occupational health professionals, employers, and workers. Dermal absorption information is useful for hazard communication andright-toknow purposes, including Material Safety Data Sheets, and product labels. Additionally, dermal absorption rate data for chemicals used or produced in particular work sites are useful in developing comprehensive safety and health programs at those facilities.

OSHA standards, including skin designations, are widely applied and referenced. Local, State, and county governments, and other Federal Agencies rely on OSHA's occupational standards, as do other national governments. It is both appropriate and
necessary to require dermal absorption rate testing ofthese industrial chemicals.

Although OSHA is the primary agency requesting the data that will be developed under this final rule, OSHA is not the onlyFederal Agency that will

use the data. NIOSH is also very interested in method-related issues associated with characterizing dermal exposure and advancing improvements in occupational exposure assessments.

EPA is also interested in data that may be gathered onthese chemicals. The information obtained bythe testing required in this final rule may be used
to inform the Agency's decisionmaking process byproviding datawhich can be used in apreliminary estimate ofthe potential health risk ofcertain chemical exposures. The 34 chemicals for which testing is required under this final rule

are part ofother ongoing Agency efforts. For example, all 34 chemicals are included in EPA's High Production Volume (HPV)Initiative (http:// www.epa.gov/chemrtk.htm.) In addition, EPA's Voluntary Children's Chemical Evaluation Program (VCCEP) (Ref.43) is designed toprovide data to enable the public to better understand the potential health risks to children associated with certain chemical exposures. Four ofthe 34 chemicals are included in EPA's VCCEP: Vinylidene chloride (Chemical Abstract Service Registry Number (CAS No.) 75-35-4); p-dichlorobenzene (CAS No. 106-46-7); ethylene dichloride (CASNo. 107-06-2); and chlorobenzene (CASNo. 108-90-7). (See http:// www.epa.gov/chemrtk/childhlt.htm.). While in vitrodermal absorption rate data are not being developed under either ofthese Agency efforts, the data may be ofbenefit in preliminary risk screening, which is the purpose ofdata gathering inthe HPV Initiative. Dermal absorption rate data may also be beneficial in further consideration of chemicals to which children may be exposed. Thus, EPA may use data obtained under this test rule in preliminary risk screenings to support its HPV Initiative and VCCEP, or for other Agency efforts to protect human health and the environment from unreasonable risks resulting from the manufacture, processing, oruse of chemicals.

In summary, the data developed under this test rule will assistthe Agency and others in evaluating these chemical substances for potential health

or safety risk concerns. Although it is
not an independent basis for supporting this final rule, as an additional benefit, the data willbe publicly available, and thus will serve to further the Agency's goal ofidentifying and controlling human health and environmental risks by providing greater knowledge to the public.

C. Categories

ACC (Ref. 15)believes that EPA should consider a category approach to dermal absorption rate testing. In reviewing the list of 79 ITC-designated chemicals, ACC concludes that agreat majority canbe grouped into categories ofsimilar chemical structure and that selected chemicals from each category could be testedfor the purpose of obtaining sufficient data that would allow an accurate prediction of dermal absorption rate for other members ofthe structural group through a combination ofmodeling and quantitative structure activity relationship (QSAR) analysis. ACC states that for the designated chemicals, these categories would include aliphatic alcohols, ketones, aliphatic hydrocarbons, nitroaliphatics, halogenated hydrocarbons, aliphatic esters, aromatic hydrocarbons, nitroaromatics, halogenated aromatics, amides, aromatic amines, and phenols/ phenol ethers. ACC suggests thatthe data generated from testing chemicals within categories could then be combined with existing data on other category members (including those in the larger group of658 workplace chemicals that were originally nominated for testingby OSHA) to attempt to correlate chemical structure with dermal absorption rates.

EPA disagrees with the category approach suggested by ACC as an alternative to the approach proposed by EPA for testing these chemicals. ACC has not provided specifics onthe number of chemicals in each category that would need to be tested and the

reason certain chemicals would be representative so that reliable structure activity predictions could be made. Twelve different structural classes were mentioned as potential categories by ACC, but additional classes would likelybe needed to categorize within the group of 79 chemicals that have been designated for testingby the ITC. EPA remains unconvinced that the approach suggested by ACC will either minimize the testing burden or more efficiently develop data on the chemicals of interest. However, the results from the dermal absorption rate testing ofthe chemicals in this final rule could, in appropriate cases, provide additional data formore thorough QSAR analysis andbetter validated models for future predictions.

D. Use ofCalculated Kps to Screenand PrioritizeChemicals

ACC commented that adequate data already exist to "reasonably determine 

### 22408

HeinOnline -- 69 Fed. Reg. 22408 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

orpredict adverse effects," according to TSCA 4(a)(1)(B), for most ifnot all ofthe chemicals included in the proposed test rule (Ref. 15). Itis ACC's understanding that the ITC calculated dermal penetration rates (Kps) for all ofthe chemicals covered by the test rule. ACC also notes that in 1992, EPA published guidance for estimating Kps for organic chemicals (see Ref. 42). The guidance document included calculated Kps for 11 ofthe 47 chemicals proposed for testing. In addition, ACC indicates that EPA's 1992 methodology has been largely validated, asthe calculated Kps closely approximate available experimentally determined penetration
rates. As such, ACC asserts that Kps, estimated using the suggested methodology, would be of sufficient quality to be used in screening-level
assessments to determine the likely influence ofdermal exposure on total worker exposure (i.e., the need for OSHA skin designations).

ACC states that EPA should consider giving industry the option ofusing calculated Kp values in lieu oftesting, and together with industry and OSHA,

assess the feasibility ofusing such data before the final rule is promulgated. ACC also states that, at a minimum, EPA should consider using calculated Kp data in order to screen and prioritize the chemicals for the proposed dermal absorption rate testing (Ref. 15).To do this, ACC states thatprior to requiring testing the available calculated Kp data shouldbe used to screen chemicals for their potential to cause systemic toxicity

as a result ofdermal exposure by assessing the potential contribution of dermal exposures to total occupational exposures, and that this assessment shouldbe used to prioritize testing needs. ACC believes that the dermal absorption rate testing shouldbe reserved for those chemicals for which screening-level assessments indicate the dermal pathway maybe ofconcern. ACC comments that neither OSHA nor EPA has attempted to prioritize chemicals using published EPA dermal
exposure assessment guidance, including published estimated dermal penetration rates.

EPA disagrees that adequate data exist
to "reasonably determine or predict adverse effects," according to TSCA 4(a)(1)(B), for the chemicals included in the final test rule. As an initial matter, EPA believes that measured Kps (i.e., those determined through well designed and conducted in vitro orin vivo testing experiments) are generally more reliable than calculated Kps, and measured Kps

are not available for the 34 chemicals subject to this final rule. EPA further believes that calculated Kp data may not be sufficiently reliable to be used in lieu oftesting or in screening-level
assessments toprioritize testing needs when the most relevant worker exposures involve exposure to neat compounds or compounds dissolved in organic solvents. With respect to the chemicals for which measured Kps are presented in Table 5-8 in EPA's 1992 guidance document (Ref.42), the Kps

were measured exclusively for the chemicals when they were in aqueous solutions; the table presents no measured Kps for neat liquids or chemicals in organic solvents, both of which are generally expected tobe more relevant to the workplace (Ref. 62). Thus, these data are not adequate to provide the information needed for OSHA's intended purpose (Ref.62). However, the in vitrotesting required by this final rule, in addition to developing data needed to assess the potential risk ofthe 34 subject chemicals, will expand the existing data base and allow more thorough comparisons ofmeasured Kps with calculated Kps relevant to occupational exposures.
E. Comments onProposed In Vitro Test Standard

1. General.EPAreceived comments supporting use ofthe proposed test standard from several groups and individuals (Refs. 25-30). Many ofthese
comments were similar in that they supported the standard as a means of gathering data without utilizing laboratory animals.

EPA agrees that there are instances, such asutilizing the test standard articulated inthis final rule, in which sufficient data on the dermal absorption
rate ofa chemical substance maybe gathered without using live laboratory animals. EPA considers many factors in relying upon specific test methods in its proposals under TSCA section 4. In specifying the standard for this rulemaking, the ITC and EPA considered the views ofthe public commenters, Federal scientists, and laboratories capable ofconducting such testing. The standard articulated in this rulemaking makes efficient use oflabor and materials and can be performed in

a consistent, economical, and timely

manner by different laboratories. The specification ofthe in vitromethod as the test standard for this final rule also reflects EPA efforts to reduce the use of animals, where appropriate, in its testing programs. However, as noted previously in Unit II.A., although this in vitromethod will satisfy OSHA's data needs to support its skin designations, EPA does not believe the method is an adequate substitute for all dermal absorption rate testing methods. 2. Technical.In addition to the general comments received by EPA on the proposed test standard, EPA also received technical comments from ACC, API, THFTF, DEPA, and a private citizen. In general, commenters argue that the proposed test standard was unnecessarily rigid and that several improvements would provide greater flexibility and reduce the cost oftesting. EPA and OSHA agree with anumber of the changes recommended byACC, API, and THFTF, and have revised the
test standard accordingly, as described in thisunit.

a. ACC, API, andTHFTF commented thatboth static andflow-through in vitro cells have been found acceptable in estimating dermal penetration of compounds. EPA agrees. Both static and flow-through in vitro cells, as described by the commenters andin the international Organization for Economic Co-operation and Development (OECD) draftguidance document (Ref.44), are acceptable for estimating dermal penetration ofcompounds (Ref. 62). EPAhas modified the test standard at paragraph (h)(5)(iii) to read: "Either static or flow-through diffusion cells
mustbe used in these studies."

b. EPAreceived acomment from a private citizen (Ref.33) who believes that more scientifically valid dermal absorption rates would be obtained by using the technologically more advanced flow-through type cells and viable human skin instead ofthe older method using static diffusion cells and cadaver skin.

EPA agrees that in some instances it maybe preferable to utilize flowthrough cell types andviable human skin to generate dermal absorption rate data. Based on this comment and similar comments byACC, API, and THFTF, EPAhas modified the test standard to allow the use of either flowthrough cells or static diffusion cells in developing the data required under this final rule (See §799.5115(h)(5)(iii) ofthe regulatory text). However, although EPA
agrees that utilizing viable human skin could provide more reliable data, EPAis requiring that human cadaver skinbe utilized for all testing required in this action. EPA's rationale for this decision is described in Unit III.E.2.o.ix.

c. ACC commented that heat
treatment to separate epidermis from dermis is an acceptable alternative to dermatome slicing forpreparing epidermal membranes. EPA agrees. The

use of a dermatome prepared skin membrane ofa thickness of 200 to 500 micrometers (um)is but one scientifically acceptable method of preparation. Peeling the epidermis from the dermis after heat treatment at 600 C 

### 22409

HeinOnline -- 69 Fed. Reg. 22409 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

for 45 seconds, as recommended by ACC (Ref. 15), or 1to 2minutes, as specified in the draft OECD guidance document (Ref.44), is also a scientifically accepted means of preparing the test membrane (Ref.62). In response to this comment, EPA specified a time range of45 seconds to 2minutes as the time for heat treatment to include the two recommended
treatment times in the ACC and OECD methods (45 seconds and 1to 2 minutes, respectively). EPA modified the required test standard §799.5115(h)(5)(ii) to read:

A suitable membrane mustbe prepared from skin eitherwitha dermatome at a thickness of200 to 500 micrometers (um), or withheat separation by treating the skinat 60' Cfor45 seconds to 2minutes afterwhich the epidermis can be peeledfrom the dermis.

d. ACC and THFTF commented that the requirement thatbarrier properties ofhuman cadaver skin mustbe pretested with a standard compound such as tritiated water prior to conducting the study should be expanded to include suitable alternatives to the use oftritiated water. (See Howes, et al., Methods for Assessing Absorption, inECVAM Workshop Report13,J.H. Fentem, ed., European Center for the Validation of Alternative Methods, 94-95 (Ispra, Italy 1996)). EPA agrees. Membrane integrity checks conducted with transepidermal
water loss (TEWL) or electrical resistance, as described by the
commenters and in the OECD guidance document (Ref.44), are acceptable alternatives to dermal penetration of tritiated water for the evaluation of human cadaver skinintegrity (Ref.62). EPA has modified the test standard in §799.5115(h)(5)(i)(D) to read:

Prior to conducting an experiment with the test substance, barrierproperties ofhuman cadaver skin mustbe pretested eitherby:

(1) measuring the movement ofa standard compound such astritiated water as discussed, forexample, in thereference in § 799.5115(h)(8)(i),

(2)determining an electrical resistance to
an alternating current, at up totwo volts, or

(3) measuring trans-epidermal water loss from the stratum corneum.

e. API, THFTF, and ACC commented that human cadaver skin samples canbe stored frozen for periods longer than 2 weeks, as proposedby EPA. Frozen storage, even for longer periods oftime, does not adversely affect the integrity of the dermal barrier (see Ref.45).

EPA agrees that for purposes ofthis
test rule, the human cadaver skin samples canbe stored frozen for periods longer than 2weeks. However, EPA does not agree with ACC that skin samples canbe frozen for up to 18 months without changes in penetration
rates for standard compounds. EPA does
not believe that a single report (Ref.45) ofacceptable skin penetration using a single substance (water)with membranes frozen for 466 daysjustifies extending the standard storage period to 18 months. Most ofthe chemicals designated for testing in this final rule

are organic chemicals with chemical properties quite different from water. EPA believes itis reasonable to extend the maximum period oftime during which human cadaver skin samples can be stored frozen (-20' C) to 3months (Ref.62). This period oftime is consistent with OECD guidance (Ref. 44). In response to these comments, EPA has modified the test standard in §799.5115(h)(5)(ii) to read:

These epidermal membranes can be stored frozen (-20' C) for up to 3 months, ifnecessary, ifthey are frozen quickly and the barrier properties ofthe samples are confirmed immediately prior to commencement ofthe experiment.

f. THFTF commented thatEPA should allow a longer, though unspecified,
amount oftime for study completion. THFTF cited three circumstances which would make more time necessary: * The practical ability ofcompanies
to test multiple materials. * The availability ofcontract facilities to conduct the testing. * The extra time needed to synthesize radiolabeled material.

EPA agrees. Circumstances may arise where the proposed 9 months would be

an insufficient amount oftime to complete testing. Therefore, EPA is extending the period oftime provided to complete the required testing from 9 months to 13 months which EPA believes should accommodate the circumstances cited byTHFTF.

g. ACC andTHFTF noted that the test standard requires a full balance sheet to demonstrate recovery ofradioactivity. (A "full balance" refers to a determination ofwhere the radiolabel is present atthe conclusion ofthe experiment (i.e., in the receptor fluid, skin sample, test vehicle, or diffusion cell) and that the recovery of radioactivity in the test system is nearly 100%). Commenters stated that it is unclear whether this requirement applies to Kp studies, to studies to

measure short-term absorption rates, or both. They assertthat fullbalance sheets

are not necessary for studies in which Kp isbeing determined. Additionally, they commented that small losses ofthe
test article do not affect the outcome of the studies because the study is, by definition, conducted with an infinite dose. (Infinite dose is the amount oftest preparation applied to the skin where a maximum absorption rate is achieved and maintained because such a volume

ensures continuous excess oftest preparation in the donor chamber.) (Ref. 44). Commenters requested that EPA clarify how accounting for losses affects Kp values.

EPA believes the test standard should require that a full balance of radioactivity be presented forboth Kp and short-term absorption rate studies,

as proposed. While EPA agrees that small losses oftest compound are tolerable in the infinite dose design, it is, nevertheless, considered good laboratory procedure and does not require excessive effort to assess recovery in experiments using radiolabeled compound (Ref.62).

h. ACC and API (Refs. 15 and 19) commented that the use ofisopropyl myristate (IPM) as a solvent in the proposed test standard is inappropriate. ACC and API stated that IPM, although frequently used as avehicle in various dermatological formulations, has questionable applicability in an occupational environment to the chemicals subject to this testrule. ACC and API also stated that IPM may not mimic workplace conditions and if used, some corrective factor shouldbe applied to determine the rate of percutaneous absorption.

EPA disagrees. IPM is an appropriate all-purpose solvent for the rare instances inwhich certain water insoluble substances capable of damaging skin are being tested (Ref. 62). ACC has not provided evidence to suggest that use ofIPM will generate distorted Kp values unrepresentative of occupational settings. Ifsuch evidence exists, EPA is willing to consider, via the procedures specified at40 CFR 790.55, in vitropercutaneous absorption experiments with other vehicles for specific test chemicals, ifthe test sponsor demonstrates that their vehicle is more representative ofrelevant occupational exposure thanIPM. EPA will not speculate on what, ifany, adjustments might be made to Kp values determined by the test standard in order "to reflect realistic exposure scenarios"

or to account for differences in regional absorption for skin.

i. ACC noted thatthe preamble to the proposed rule indicates that the parent chemical andits major metabolites are to be detected in certain cases, and requested clarification as to which of the major metabolites ofthe chemicals this requirement applies.

In the proposal to this action, EPA mentioned that the measurement of major metabolites in the receptor fluid 

### 22410

HeinOnline -- 69 Fed. Reg. 22410 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

is done when viable skin is used and significant dermal metabolism is anticipated. However, EPA did not propose nor is EPA requiring that live skinbe used and skin viability be maintained during performance ofthe required tests. Therefore, EPA is also
not requiring measurement ofmajor metabolites in the receptor fluid. (See Unit III.E.2.o.ix.).

j. ACC was unsure whether EPA's proposed test standard would require the use of6 or 18 human cadaver skin samples per chemical. EPA is requiring

aminimum of 18 human cadaver skin samples per chemical. EPAhas modified the test standard at §799.5115(h)(5)(i)(B) to clarify that data
must be obtained from a minimum of six samples for each ofthe determinations, i.e., Kp, 10-minute short-term absorption rate, and 60- minute short-term absorption rate. Also, the samples used for the testing of a given chemical must come from at least three different human subjects, with two samples from each subject being used for each determination to allow for biological variation among subjects. (See §799.5115(h)(5)(i)(B) ofthe regulatory text).

k. ACC commented that in §799.5115(h)(5)(v) ofthe proposed regulatory text itis unclear whether it is necessary to demonstrate that the concentration ofa test substance in the donor chamber has remained at greater than 90% ofits original value, or that the concentration ofthe test substance in the receptor fluid is less than 10% of the initial test substance concentration in the donor chamber. Similarly, THFTF commented that §799.5115(h)(5)(v) of the proposed regulatory text should be revised to state thatphysicochemical data or experimental results should be used to show that about 10 times the concentration in the receptor fluid is achievable under experimental conditions. This will ensure thatback diffusion is not significant. See the OECD Guideline 1999 (Ref.44).

EPA has removed the language in question in §799.5115(h)(5)(v) ofthe regulatory text, and has inserted related
text in the test standard at §799.5115(h)(5)(iii) to read:

To ensure that an increase in concentration ofthe test substance in thereceptor fluid doesnot alter penetration rate, the testing laboratory must verify thatthe concentration ofthe test substance in thereceptor fluid is less than 10% ofthe initial concentration in the donor chamber.
This requirement applies to all chemicals to be tested, including hydrophobic chemicals.

1.ACC commented thatthere is some confusion created by inconsistencies between statements in the proposed rule preamble andrequirements in the proposed test standard. ACC points out that the preamble states that "the
measurement ofa short-term absorption
rate is only required when a Kp cannot be obtained using this standard," whereas §799.5115(h)(5)(vii)(B) ofthe proposed regulatory text states that "Short-term absorption rates must be determined for all chemicals." Itis not clear to ACC why short-term absorption
rates must be determined for all test chemicals. ACCbelieves that ifa chemical affects the skin and a Kp value
cannot be determined, determining aKp rate is moot. Knowledge ofthe shortterm rate isnot useful in determining Kp values. API similarly commented that itis not clear why determining the short-term absorption rate for each test rule chemical is necessary.

EPA is requiring the measurement of short-term absorption rates for all chemicals included in this final rule. The panel ofFederal scientists that refined the method ofBronaugh and Collier (Ref. 13) recommended that all chemicals be tested for short-term absorption in order to obtain in vitro dermal absorption rate measurements for briefdermal exposures that commonly occur in occupational settings, such as spills or splashes. EPA believes that the panel's rationale supporting the testing ofall chemicals for short-term absorption is reasonable.

m. ACC and THFTF commented that the correct unit ofmeasurement is micrometers, not millimeters, as stated in §799.5115(h)(5)(ii) ofthe proposed regulatory text. EPA agrees thatthe
correct unit ofmeasurement is micrometers, not millimeters. EPA has corrected the test standard in §799.5115(h)(5)(ii) ofthe regulatory text to reflect this.

n. DEPA argues that the proposed test standard isunacceptable for measuring very volatile liquids, such as ethyl ether, because efforts toprevent evaporation would lead to unrealistically high
pressures, leakage ofmaterial from the cell, damage to the skinmembrane, and other substantial technical difficulties. EPA disagrees. DEPA did not provide any evidence to suggest, nor is EPA
aware, that any such problems have ever been reported. However, in those instances where atest sponsor can document that closed (i.e., occluded) conditions lead to leakage ofmaterial or damage to the skin membrane or similar technical difficulties, in vitro percutaneous dermal absorption rate experiments with the skin surfaces uncovered (unoccluded) may be substituted, via the provisions in 40 CFR 790.55, ifEPA agrees that conducting the study in such amanner is more technically feasible and appropriate.

o. THFTF suggested numerous minor changes to the test standard that EPA believes go against either the recommendations ofthe ITC expert panel or TSCA Good Laboratory Practice Standards (GLPS) at 40 CFRpart 792, and do not enhance the validity or acceptability ofthe method. The suggested changes include:

i. Removing the requirement that the time elapsedbetween the death and harvest ofhuman skin specimens be reported. EPA believes that all experimental parameters shouldbe reported in accordance with TSCA GLPS, andhas retained this requirement in the final rule.

ii. Removing the requirement that the thickness ofthe skin membrane be reported. EPA believes that all experimental parameters shouldbe reported in accordance with TSCA GLPS, andhas retained this requirement in the final rule.

iii. Requiring solids to be applied directly to the skin and determining percentage absorbed rather than dissolving solids in avehicle and determining Kp. EPA disagrees. Although there maybe instances where

some ofthe test rule chemicals that are solids at room temperature have dermal
exposures limited to the chemical in solid form, it is also possible based on

common industrial practices, that there willbe occupational exposures to these chemicals when they are dissolved or suspended in an aqueous or solvent medium. In addition, test solutions are

more suitable for determining Kp values for chemicals that are solids at room temperature. Thisis because solutions in contact with the skin are uniform and haveknown concentrations, which is
notnecessarily the case with solids in
contact with skin (Ref.63). Therefore, EPA is generally requiring, as proposed, that chemicals that are solids atroom temperature be dissolved in water. Ifthe chemical is hydrophobic andits concentration in water is not high enough to obtain a steady-state absorption, the chemical must be dissolved inisopropyl myristate. However, in those instances where a test sponsor can document that occupational
exposure is limited to a chemical in solid form, development of percutaneous dermal absorption rate experiments with solid material may be substituted, via the provisions contained in 40 CFR 790.55, ifEPA agrees that conducting the study in such

a manneris more appropriate.

iv. Specifying fixed amounts oftest chemical, 10 milligrams per centimeter 

### 22411

HeinOnline -- 69 Fed. Reg. 22411 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

squared (mg/cm2) for dry solid or 10 microliters per centimeter squared (ul/ cm2) for liquids, be used in short-term absorption rate experiments rather than simplyrequiring the use ofsufficient
test chemical to cover the skin and reporting the quantity used. EPA disagrees. It is not necessary to specify that all substances be tested at the same fixed volume per skin area. The size of the diffusion chamber will partially determine the volume ofrequired test material. The important issue isthat sufficient test chemical is available to completely cover the skin. This is because the absorption rate of a chemical is reported per square centimeter ofskin, thus, itis necessary to precisely ascertain the area of skin contacted (Ref.63).

v. Requiring three rather than four absorption measurements for determination ofKp. EPA disagrees. The panel ofFederal scientists thatrefined the Bronaugh and Collier method (Ref. 13) for use as the test standard in this final rulebelieves that three
measurements duringthe steady state absorption period are inadequate to accurately determine the Kp and that an additional measurement is necessary for this purpose (Ref.62). As a result, EPA is retaining the requirement in this final rule that four absorption measurements be taken for the determination ofa Kp.

vi. Specifying that exposure time shouldbe up to 8 hours for estimating dermal absorption offinite doses. EPA disagrees. EPA does not believe that it will be necessary to test each ofthe chemicals for as long as 8 hours. Infact in many instances, the study can be completed in an hour.However, there may be chemicals for which the study could require up to 24 hours to complete. Therefore, EPA believes that specifying a study duration ofup to 8 hours is inappropriate (Ref. 63). However, ifa test sponsor provides EPA with documentation that an alternate
exposure time for a specific chemical is

more relevant than the exposure time specified in this final rule, EPA may provide for the substitution ofother
exposure durations for the development ofin vitropercutaneous dermal absorption rate experiments, via the provisions contained in 40 CFR 790.55, ifEPA agrees that conducting the study in such a manner is more appropriate.

vii. Allowing 1:1 ethanol:water to be used as receptor fluid for hydrophobic chemicals in addition to 6% polyethylene glycol (PEG)in water. EPA
agrees that a 1:1 ratio of ethanol to water is a suitable receptor fluid for hydrophobic chemicals. However, EPA is specifying thatthe PEG receptor solvent at a concentration of6% be used for testing ofhydrophobic chemicals. EPA believes that specifying the use of the single PEG receptor solvent for these chemicals should ensure more uniform and consistent results. Specifying that a single receptor fluidbe used for all hydrophobic chemicals will enhance the interpretability oftest results for these chemicals (Ref.63).

viii. Not expressing short-term finite absorption as a rate, i.e., micrograms per hour per centimeter squared (ug/h/cm2), because the true absorption rate is likely
to change over the time interval during which absorption is being measured. This is to be distinguished from Kp determinations at steady state conditions under which there is little change in an absorption rate over time. The commenter suggests that cumulative amount absorbed per area, i.e., micrograms per centimeter squared (ug/cm2) is a more appropriate way to express the data.

EPA disagrees. EPAis aware ofthe distinctions between a short-term absorption rate measured under nonsteady state conditions and a Kp value based on a steady state absorption rate. (See §799.5115(h)(5)(vii)(A) ofthe regulatory text which states that an infinite dose must be applied to the skin
to achieve a steady-state rate of absorption for calculation ofa Kp.) Concerning the units to be used for short-term absorption rates, EPA does
not agree that expressing short-term absorption data as cumulative amount per area rather than a rate provides any interpretive advantage. A short-term absorption rate represents the average absorption over the time interval during which itis measured. The true rate will usually be greater than the average rate early in the time interval and less than the average rate later in the time interval. A determination of cumulative
amount absorbed per unit ofarea provides only end ofthe experiment information rather than information about the average rate during the course ofthe test. EPA is requiring that the results be expressed as a rate (ug/h/ cm2), rather than as an amount per area (ug/cm2) in order tobe consistent with
rate units used to calculate Kp (Ref.63).

ix. Allowing the use ofhuman skin obtained from cosmetic surgery (breast and/or abdominal skin) as an alternative
to human cadaver skin for testing. In refining the test method, the ITC and EPA considered the collective views of commenters, Federal scientists, and laboratories capable ofconducting such testing. The test standard specifies the

use ofhuman cadaver skinwhich EPA believes makes efficient use oflabor and materials and can easily be performed by many different laboratories. EPA believes that the use ofthis human cadaver skin will provide the desired results in an economical and timely

manner. Although EPA agrees that a method utilizing viable human skin could provide more reliable Kps for compounds in which skin metabolism influences dermal penetration, EPA does not believe that extensive metabolism is likely, based on the physical chemical properties, for the 34 chemicals subject to this final rule. Based onthe public comments received and discussions with Federal scientists and laboratories capable ofconducting such testing, EPAbelieves that performing the study with skinfrom cosmetic surgery could increase test costs. As aresult, the final test standard requires the use ofhuman cadaver skin.

x. Notrequiring the use of radiolabeled materials in the required testingbecause many chemicals subject
to the final rule are unlikely to be readily available inradiolabeled form. Thus, itwill take additional time to prepare an adequate supply of radiolabeled chemicals, potentially adversely affecting industry's abilityto meet the regulatory deadlines established for completing the testing and submitting the test results.

EPA disagrees. This comment was in reference to a single chemical (tetrahydrofuran) and was the only
comment which indicated that radiolabeled materials are not available off-the-shelt EPAbelieves that radiolabeled materials are likely tobe available for at least some ofthe other chemicals included in this final rule. In those instances where radiolabeled materials are not currently available and
mustbe synthesized, EPA believes that the additional amount oftime provided in thisfinal rule (see Unit III.E.2.f.) is sufficient both to prepare suchmaterials and complete the testing. Also, radiolabeling is not an uncommon analytical procedure and there are many different laboratories (Ref. 46) inthe United States that are capable of preparing radiolabeled materials. Finally, the test itselfis short-term, generally taking no longer than 24 hours
to complete. The Agency has provided
test sponsors with 13 months to complete the requirements established underthis final rule. To the extent that

a test sponsor does require additional timeto comply with the final rule, an extension from EPA maybe requested utilizing the procedures at 40 CFR 790.55.

xi. Deleting the word "live" as used in §799.5115(h)(5)(i)(A) ofthe proposed regulatory text which states "the most accurate absorption rate data for regulatory concerns related to human 22412

HeinOnline -- 69 Fed. Reg. 22412 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

health wouldbe obtained with live human skin." In the course of developing the final test rule, EPA deleted this statement from the test standard primarily for the reasons presented in Unit III.E.2.o.ix.

F. ChemicalSpecificComments

Chemical specific comments on ethyl ether (CAS No. 60-29-7), isobutyl alcohol (CASNo. 78-83-1), sec-butyl alcohol (CASNo. 78-92-2), odichlorobenzene (CAS No. 95-50-1), pnitrotoluene (CAS No. 99-99-0), betachloroprene (CAS No. 126-99-8), namyl acetate (CASNo. 628-63-7), Nisopropylaniline (CASNo. 768-52-5), and o-dinitrobenzene (CASNo. 528-29- 0) are addressed in Unit VII.

1.Acetonitrile.The Acetronitrile Task Force commented thatthe total number ofworkers associated with acetonitrile (CASNo. 75-05-8) production in the United States is on the order of 500 (Ref. 23). The Task Force believes that EPA has included laboratory personnel in its larger estimate as the Agency's figure far exceeds the number ofpersonnel involved in manufacturing the chemical. The Task Force notes that analytical laboratory personnel are well trained in safely handling hazardous materials ofthis type, and that these workers typically handle small volumes ofacetonitrile.

EPA reviewed the Acetonitrile Task Force's estimate ofthe number of workers exposed to acetonitrile at manufacturing sites, but did not find that the information provided sufficient basis to conclude that there are not substantial numbers ofworkers potentially exposed to acetonitrile during manufacturing, processing, and

use. Although EPA requested the Acetonitrile Task Force toprovide documentation for its estimate ofthe number ofworkers exposed to acetonitrile, EPA did not receive any further information from the Task Force in support ofits estimate. Also, the NOES data usedby EPA did include laboratory personnel and EPAbelieves it is appropriate to include them because they are potentially exposed. EPA believes that employee training does not assure that exposure will not

occur and is no basis for the assertion that laboratory employees will have no exposure. EPA also believes that the Task Force's estimate that 500 employees are potentially exposed may be low ifit did not include laboratory personnel. Absent specific data indicating otherwise, EPA believes the NOES database should be used to estimate worker exposure because itis the mostrecent and comprehensive

source ofthis kind ofinformation. Therefore, EPA is requiring the testing ofacetonitrile to determine an in vitro dermal absorption rate.

2. Carbondisulfide.ACC's Carbon Disulfide Panel cited three studies summarized in an Agency for Toxic Substances and Disease Registry (ATSDR) document (Toxicological Profile for CarbonDisulfide(August 1996), p. 65-66) as a supporting rationale for its assertion that sufficient data existfor carbon disulfide (CASNo. 75-15-0) and thattesting ofcarbon disulfide istherefore, unnecessary (Ref. 39). One 30-year-old study estimated dermal absorption by measuring very small changes in carbon disulfide solution before and after immersion of the hand (T.Dutkiewicz and B. Baranowska. 1967. The significance of absorption ofcarbon disulfide through the skin in the evaluation ofexposure. Toxicology ofCarbonDisulfide. Proceedingsofa Symposium, Prague, 1966,pp. 50-51). EPA reviewed this study and considered the methodology flawed due to its indirect measurement andpotential failure to control for volatilization. In the other two studies cited by the Carbon Disulfide Panel (A.E. Cohen, et al. 1958. Skin absorption ofcarbon disulfide vapor in rabbits. I. Associated changes in blood protein and zinc. AMA Archives ofIndustrial Health, 17:164-169; and H. Drexler, et al. 1995. Carbon disulfide. 2. Investigations onthe uptake ofCS 2 and the excretion ofits metabolite 2- thiothiazolidine-4-carboxylic acid after occupational exposure. International Archives ofOccupational EnvironmentalHealth,67:5-10), EPA
notes that a dermal absorption rate was not determined and could not be derived using the data gathered (Ref. 62).

The Carbon Disulfide Panel also cited

a dermal absorption rate calculated by EPA for carbon disulfide in composted sludge at a level of0.59 milligrams per kilogram (mg/kg) soil.EPA notes that the dermal absorption rate was not experimentally determined, but was estimated from low environmental levels in composted sludge rather than the potentially higher worker exposure to the undiluted liquid (Ref.62). EPA and OSHA donot consider the data cited by the Carbon Disulfide Panel to be sufficient to determine a useful and reliable dermal absorption rate (Ref. 62).

The Carbon Disulfide Panel also cited ATSDR's statement that "carbon disulfide partitions immediately to the air when released to the environment, and does not therefore expose humans
to carbon disulfide through oral or dermal contact" (ToxicologicalProfile forCarbonDisulfide(August 1996), pp. 134-141). EPA notes that this statement refers to dermal contact with environmental media that had been contaminated with carbon disulfide, not
to occupational exposure (Ref. 62). In fact, the same document makes it clear that the main way workers are exposed

to carbon disulfide is through the inhalation ofvapors and dermal contact (ToxicologicalProfile for Carbon Disulfide(August 1996), pp. 9 and 63). Therefore, EPA is requiring the testing ofcarbon disulfide to determine an in vitrodermal absorption rate in this final rule.

3. Naphthalene. ACC's Naphthalene Panel commented that dermal toxicity data generated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) makes the [proposed] test rule unnecessary [with respect to naphthalene] (Ref. 34). The Naphthalene Panel comments summarize four unpublished studies submitted under FIFRA to support the registration of naphthalene (CAS No. 91-20-3) as an active ingredient in moth repellants. One study reports the simulated amount ofnaphthalene that would be deposited

on the hands ofa homeowner handling mothballs. However, the study did not simulate occupational exposure and a dermal absorption rate was not measured. The other three studies were toxicity investigations in which the test compound was topically applied to animals, but none ofthe studies measured the rate ofabsorption. The toxicity endpoints examined (mortality, body/organ weights, hematology, gross tissue examination, skin lesions) related

to only dermal irritation or advanced systemic effects (Ref. 62). EPA and OSHA do not consider the data cited by the Naphthalene Panel to be sufficient

to determine a dermal absorption rate. Therefore, EPA is requiring the testing ofnaphthalene to determine an in vitro dermal absorption rate in this final rule.

The Naphthalene Panel also commented that EPA's proposed test rule for certain Hazardous Air Pollutants (Ref. 48) estimated that 23,092 workers are exposed to naphthalene, yet, the proposal to this final rule estimated that 112,695 workers are exposed to naphthalene. In both proposals, EPA cited the NOES as the basis for the estimates. The Naphthalene Panel argued that neither figure is correct and that an informal
survey ofNaphthalene Panel members, which comprise the major manufacturers and importers of naphthalene, showed that only approximately 263 workers are potentially exposed during naphthalene manufacturing activities in the United States. The Naphthalene Panel also 

### 22413

HeinOnline -- 69 Fed. Reg. 22413 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

argued that the NOES did not obtain information on the frequency, concentration, nor duration ofworker
exposure to naphthalene, and therefore EPA should not rely onthe NOES to find "substantial" or "significant" worker exposure. Furthermore, although the criteria stated in EPA's "B" policy for finding "substantial" human
exposure may be met (Ref.55, p. 28746), the Naphthalene Panel believes NOES does not show worker exposure to naphthalene atlevels thatmay cause health concerns. Moreover, the Naphthalene Panel indicated (without providing further specific information) that NOES does not reflect current workplace conditions ornaphthalene
exposure levels.

EPA acknowledges that different estimates for the numbers ofworkers exposed to naphthalene were cited in the two proposed test rules indicated by the commenter and that these estimates

were both from the NOES. The estimate of23,092 workers in the Hazardous Air Pollutants proposal (Ref.48) was based

on an interim report (Ref.49) compiled in March of 1989. The NOES database

was still being updated after that time until June 1990, when the final update

was completed and trade name product resolution ceased. The estimate of 112,695 potentially exposed workers cited in the proposal to this final rule

was based on the final update ofthe NOES. The figure is still the mostupto-date NOES information EPA has related to potential worker exposure to naphthalene, which includes employee
exposure information on both manufacturing and processing sites. EPA considered the results ofthe Naphthalene Panel's survey ofits members which found that 263 workers

were potentially exposed at their manufacturing sites. However, that number does not include an estimate of the number ofemployees potentially exposed to naphthalene at processing sites.

As stated in Unit III.B.1.a., it is EPA's beliefthat the "substantial" human
exposure finding in TSCA section 4(a)(1)(B)(i)(II) was intended to address situations in which large numbers of people, in this instance, large numbers ofworkers, may be potentially exposed
to a chemical substance. EPA is not required to make a finding that a chemical substance would pose an unreasonable risk ofinjury at some hypothetical level oftoxicity and
exposure in order to require testing under TSCA section 4(a)(1)(B). See ChemicalManufacturers Associationv. EPA, 899 F.2d 344, 354-55 (5 th Cir. 1990). EPA has made the necessary findings under TSCA section 4(a)(1)(B), and EPA is therefore requiring the testing ofnaphthalene to determine an in vitrodermal absorption rate in this final rule.

4. Biphenyl. The Biphenyl Work Group (BWG) commented thatbiphenyl (CASNo. 92-52-4) currently has two primary uses. Both uses are in closed systems either as a chemical intermediate or as acomponent of thermal fluids in highly specialized, closed industrial heat transfer systems (Ref.20). The BWG states thatprevious industrial uses ofbiphenyl in fruit wrappings and as a dye carrier have been phased out. Therefore they state that any exposure to biphenyl is unlikely. The BWG asserts that only very low airborne exposures ofbiphenyl

are found in manufacturing facilities and facilities using heat transfer fluids. They state that, with reference to the biphenyl occupational exposure limit of 200 parts per billion (ppb) (29 CFR 1910.1000(a), Table Z-1), occupational airborne exposures are very low. The BWG estimated that atpresent, no more than 100 workers are involved in U.S. biphenyl production (including maintenance and laboratory personnel) and fewer than 100 workers have potential dermal exposure in heat transfer uses.

EPA reviewed the BWG's estimate of number ofworkers exposed to biphenyl, but did not agree thatthe information provided sufficient basis to conclude that there are not substantial numbers of workers potentially exposed to biphenyl (Ref.67). Although EPA requested the BWG to provide documentation for its estimate ofthe number ofworkers exposed to biphenyl, EPA did not receive any further information from the BWG to support its estimate. Absent specific data indicating otherwise, EPA believes the NOES database shouldbe used to estimate worker exposure because itis the mostrecent and comprehensive source ofthis kind of information. Therefore, EPA is requiring the testing ofbiphenyl to determine an in vitrodermal absorption rate.

5.p-Xylene,pentane,nonane,andnheptane.The Hydrocarbon Solvents Panel states that EPA should be able to reliably determine dermal absorption
rates for untested members of a chemical category by comparing the logarithms oftheir octanol-water partition coefficients (log Kow) to those ofstructurally similar category members which have data on dermal absorption
rates (Ref.37).

The Hydrocarbon Solvents Panel did
not provide sufficient detail to evaluate its case for a category approach with these four chemicals. The Hydrocarbon Solvents Panel also did not provide any data, nor is EPA aware ofany data, which would provide EPA with a reliable estimate ofthe dermal absorption rate for p-xylene, pentane,
nonane, and n-heptane. Therefore, EPA is requiring testing ofp-xylene, pentane,
nonane, and n-heptane.

6.p-Dichlorobenzeneand chlorobenzene.The Chlorobenzene Producers Association cited anumber of
acute dermal toxicity studies forpdichlorobenzene (CASNo.106-46-7) and chlorobenzene (CASNo. 108-90-7)
to support its position that testing of these chemicals is unnecessary (Ref.31). In addition, the Association cited EPA's Dermal ExposureAssessment: Principles andApplications(Ref.42), which described calculated Kps for chlorobenzene andp-dichlorobenzene.

EPA disagrees with the comment that testing chlorobenzene andpdichlorobenzene is unnecessary because existing data on dermal toxicity or calculated Kp values are sufficient to reasonably predict the human health effects ofdermal exposure to these chemicals. None ofthe studies cited by the Chlorobenzene Producers Association for chlorobenzene orpdichlorobenzene specifically measure the dermal absorption rate ofthese chemicals or provide data by which dermal absorption rate canbe determined. The Kp values cited in the 1992 EPA Dermal Exposure Assessment Report for the two chemicals are estimated from empirical models and
not experimental data and, therefore, do
notmeet OSHA needs. Therefore, EPA is requiring testing ofchlorobenzene andp-dichlorobenzene to determine an in vitrodermal absorption rate.

7. Tetrahydrofuran. THFTF commented that quantitative dermal absorption data for tetrahydrofuran (CAS No. 109-99-9) are not needed by OSHA to establish its skin designations because OSHA has established skin designations in the past without such data. THFTF also commented that "current MSDS warnings and product stewardship efforts" are adequately protective against harmful dermal
exposure to tetrahydrofuran in the workplace (Ref. 32).

OSHA's current skin designations (29 CFR 1910.1000, Table Z-1) were originally recommendations made by the Threshold Limit Value (TLV) Committee ofthe American Conference ofGovernmental Industrial Hygienists (ACGIH) in 1970 or prior to 1970, and adopted without reservation by OSHA in 1971. Itis true that OSHA was able
to set the original "skin designations" without quantitative dermal absorption data. However, OSHA currently believes that now andin the future when a skin 

### 22414

HeinOnline -- 69 Fed. Reg. 22414 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

designation is included in a standard that limits occupational exposure, it shouldbe supportedby a scientific determination ofthe ability or speed of the substance tobe absorbed through the skin after dermal contact. Because methods are now available to provide this information for human skin, OSHA is seeking such testing.

Regarding "current MSDS warnings andproduct stewardship efforts," EPA agrees with THFTF that these vehicles have been important in reducing worker
exposures, but they are only as good as the scientific data on which they are based. To ensure that the exposure limits endorsed by MSDSs are sufficiently protective, dermal absorption rate information is needed to better understand the contribution to total exposure from the dermal route.

8. Dipropyleneglycolmethyl ether. ACC's Propylene Glycol Ethers Panel cited a number ofacute, subacute, and subchronic toxicity studies on dipropylene glycol methyl ether (CAS No. 34590-94-8), including studies via the dermal route, to support the position that testing this chemical is unnecessary (Ref.35). None ofthe studies described in the Panel's comments specifically

measure the dermal absorption rate of dipropylene glycol methyl ether nor can dermal absorption rates be derived from the data provided in those studies (Ref. 64). Therefore, EPA isrequiring testing ofdipropylene glycol methyl ether to determine an in vitro dermal absorption
rate.
G.LaboratoryCapacity

API and THFTF commented that EPA should consider ongoing demands for laboratory services. API noted that government and industry are currently involved in many testing projects, including the voluntary HPV Challenge Program (Ref.51). API suggested that EPA evaluate laboratory capacity and the combined demand that multiple testing programs will create. Likewise, THFTF warned ofthe possibility that available laboratory expertise will be overwhelmed by the testing required in this final rule.

In specifying the in vitrodermal absorption rate test standard for this rulemaking, EPA concluded that the test standard uses labor and materials efficiently and can be performed in the

manner described by a variety of laboratories. The Agency has conducted, in addition to the analysis (Ref. 52) described in the proposal to this rulemaking (Ref. 5), two more recent studies (Refs. 46 and 53) oflaboratory capacity associated with its other chemical testing programs. These two studies provided further support to EPA's beliefthat there is sufficient laboratory capacity to accommodate the testing which isrequired bythis final rule.

The testing required under this rulemaking is not very complicated. The in vitrotests are ofshort duration, generally taking no longer than 24 hours
to complete. The Agency has provided
test sponsors with 13 months to complete the requirements established under this final rule. EPA does not believe that the relatively modest
amount ofnew testing required (atotal ofthree tests on each of 34 chemicals) will exceed the available laboratory capacity, particularly given the shortterm nature ofthe testing, the relatively low cost ofthe tests, and the long time period allowed for completing the studies. Furthermore, based on the analyses developed by EPA (Refs. 46, 52, and 53), EPA does not believe the cumulative impacts associated with a variety ofits existing chemical testing programs is likely to overwhelm the available laboratory expertise as suggested byAPI and THFTF.

H. ExportNotification
Several issues raised in comments relate to EPA's implementation ofTSCA section 12(b) (15 U.S.C. 2611(b)) export notification requirements for chemicals for which the submission of data is required under TSCA section 4. Section 12(b) ofTSCA states, in part, thatany person who exports orintends to export to a foreign country a chemical substance ormixture for which the submission of data is required under TSCA section4 must notify the EPA Administrator ofsuch export or intent
to export. The Administrator in turn will notify the government ofthe importing country ofEPA's regulatory action with respect to the substance. EPA's regulations implementing TSCA section 12(b) are at 40 CFR part 707, subpart D.

As a general matter, comments on the scope ofEPA's regulations under TSCA section 12(b) are beyond the scope of this rulemaking. However, three
comments associated with the requirements under TSCA section 12(b) domerit some discussion in this preamble.

1.Application to chemicalin any form. ACC commented that EPA's
statement in its proposed rule that export notification requirements would apply to exporters ofthe chemical substances subject to the final rule regardless ofthe form (e.g., byproduct, impurity) in which they are exported constitutes an unprecedented expansion ofthe TSCA section 12(b) notification requirements. EPA disagrees with this comment. TSCA section 12(b) and the implementing regulations at40 CFR part 707 apply, in part, to the export or intended export of a chemical substance for which the submission of data is required under TSCA section 4. Neither the statutory nor the regulatory language restricts this requirement to exporters of chemical substances andmixtures in particular forms, but instead generally extends export notification requirements to exporters ofchemical substances and mixtures without regard
to the formin which the chemical substances and mixtures are being or willbe exported. The language in the proposed rule and inthis final rule are not an expansion ofthe TSCA section 12(b) notification requirements. Itis noted, however, that the Agency did not intend to change the current export notification provisions affecting articles which specify that no export notification is required for articles, except polychlorinated biphenyl articles, unless required in specific section 5, 6, or 7rules. See 40 CFR 707.60(b).

2. Exporterssubjectto notification requirement.ACC states that TSCA section 12(b) limits the imposition of export notification requirements related
to TSCA section 4 actions to persons who actually have testing obligations underTSCA section 4.EPA disagrees. TSCA section 12(b)(1) and the implementing regulations at40 CFR part 707, subpart D apply to any person who "exports or intends to export to a foreign country a chemical substance or mixture for which the submission of data isrequired under [TSCA section 4]." (15 U.S.C. 2611(b)(1)). Under 40 CFR 707.65(a)(2)(ii), exporters must notifyEPA oftheir first export or intended export to a particular country when data are required underTSCA section 4. EPA believes the language unambiguously requires notification of exportby exporters of substances which

are the subject ofTSCA section 4 actions regardless ofwhether the exporters themselves are also subject to the underlying TSCA section 4 rules. Thus, exporters ofa chemical substance that is covered by data submission requirements under TSCA section4, including persons who are not otherwise subject to the TSCA section 4 rule itselfas manufacturers and/or
processors, are subject to export notification requirements under TSCA section 12(b).

3. Informationcollectionrequest (ICR). API suggests that, because this final rule will result in the requirement that export notifications are submitted
to EPA for exports orintended exports 

### 22415

HeinOnline -- 69 Fed. Reg. 22415 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

ofthe substances covered by the final rule, this is a new information collection activity that requires OMB review (Ref. 19). Furthermore, API believes that EPA's cost estimates for TSCA section 12(b) notification ignores the biggest costs associated with export notification, which are the internal training and systems necessary to identify exports against the export notification list, tracking ofwhat notifications have already been submitted andto what countries, and so forth. These system costs are magnified when business operations change (e.g., sales, acquisitions, and so forth) and export notification systems need tobe adjusted accordingly.

EPA disagrees that this action is a

new collection ofinformation requiring OMB review. The information collection activities related to export notification under TSCA section 12(b)(1) are approved under OMB control number 2070-0030 (EPAICR No. 0795). The methodologies, assumptions, and estimates developed byEPA for implementation ofTSCA section 12(b) have been reviewed under notice and
comment procedures during the development ofthe ICR. EPAbelieves it would be more appropriate to address API's burden concerns in the context of the ICRrenewal process and therefore will not respond to them in the context ofthis final rule.

L PersonsRequiredto Test

EPA stated in the proposed rule that manufacturers andprocessors ofthe chemical substances included in the final rule wouldbe subject to the final rule. As in the past, under the procedures set forth at40 CFR part 790, the persons subject to the final rule fall into one oftwo groups, designated here

as Tier 1 and Tier 2. Persons in Tier 1 (those who would initially have to comply with the final rule) would be obligated either to: Submit to EPA letters ofintent to conduct testing, conduct this testing, and submit the test data to EPA or apply to and obtain from EPA exemptions from testing. Persons in Tier 2 (those who would not have to initially comply with the final rule) would not need to take any action unless they are notifiedby EPA that they are required to do so. Persons in Tier 1who obtain exemptions and
persons in Tier 2would nonetheless be subject to providing reimbursement to persons who actually conduct the testing.

Under 40 CFR part 790, EPA traditionally has treated the following
persons asbeing in Tier 2in TSCA section 4(a) test rules:

* Processors (40 CFR 790.42(a)(2)). * Manufacturers ofless than 500 kg (1,100 lbs) per year ("small-volume manufacturers") (40 CFR 790.42(a)(4)). * Manufacturers of small quantities for research and development ("Research and Development (R&D) manufacturers") (40 CFR 790.42(a)(5)).

In the proposed test rule, EPA reconfigured the tiers in 40 CFR 790.42 by adding the following persons to Tier 2: Byproduct manufacturers; impurity manufacturers; manufacturers of naturally occurring substances; manufacturers ofnon-isolated intermediates; and manufacturers of components ofClass 2 substances. The Agency also proposed thatpersons who donot know or cannot reasonably ascertain that they are manufacturing or processing the chemical substances included in the final rule would notbe subject to the final rule.

EPA's proposed approach to the "persons required to test" portion of this test rule was intended to clarify subject entities' obligations under the final rule and focus the testing requirements initially on those entities whom EPAbelieves would be most likely to conduct testing (Ref. 5,pp. 31080-31082). EPA solicited comment

onthis new approach to the "persons required to test" portion ofthe test rule, andreceived a number ofcomments. After considering these comments, EPA has decided to finalize the approach as proposed, with the addition of provisions related to the "subtiering" of Tier 2 entities (see Ref. 5,pp. 31081- 31082, and Unit 111.1.3.).

1. GeneralagreementwithEPA's "personsrequiredto test" approach.All the commenters on the new approach to the "persons required to test" section of the proposed rule agreed that manufacturers ofbyproducts and impurities and processors are appropriately placed in Tier 2.These
commenters also agreed thatthe persons EPA has put in Tier 1 are appropriately placed in Tier 1. API stated that the approach inthe proposed rule "appropriately focuses the rule, will reduce burden and complexity, and will facilitate timely accomplishment of testing." API also agreed with the Agency's rationales for tiering. AFPA stated that the new "persons required to test" approach would provide greater certainty to people about what they
must dounder the final rule.

ACC/O and ACC/KO additionally agreed with the inclusion of manufacturers ofcomponents ofClass 2 substances in Tier 2. API agreed with the exclusion ofmanufacturers or processors who do not know or cannot reasonably ascertain that they are manufacturing or processing a test rule substance.

2.EPA shouldretaintheabilityto

move Tier2groupsto Tier 1.AFPA, ACC/0, and ACC commented that EPA should retain the flexibility to move Tier 2groups to Tier 1 on a case-by-case basis. For example, ifcertain processing activities cause special risks, then processors couldbe brought into Tier 1 upfront in the proposed rule. Ifcasespecific justifications exist for moving Tier 2entities to Tier 1,EPA should
state these justifications publicly.

EPA agrees that the Agency should retain the ability to elevate Tier 2 entities to Tier 1 on a case-specific basis in future test rules, andwhere the Agency takes such an action, itwill
state itsjustification(s) for doing so. For example, ifEPA is able to determine that a chemical ismanufactured solely

or primarily in the form ofa byproduct, EPA may propose to include persons who manufacture that chemical as a byproduct in Tier 1, even though byproduct manufacturers ofother chemicals listed in the same proposed rule might otherwise be included inTier 2.EPA does not agree, however, that risk shouldbe abasis for moving entities from Tier 2to Tier 1 (see Unit 111.1.4.).

EPA will continue to retain flexibility

over the status of entities covered by Tier 2consistent with EPA's flexibility

over the narrower group of entities that havebeen included in Tier 2in previous test rules; processors, smallquantity manufacturers (i.e., manufacturers ofless than 500 kg (1,100 lbs.) ofa test rule chemical), andR&D manufacturers (40 CFR 790.42(a)(2), (a)(4), and (a)(5), respectively). In the final rule which established the general Tier 2 status of small-quantity and R&D manufacturers and processors intest rules, EPA stated that it "reserves the rightto differ from the general procedure in this final rule by proposing in a specific TSCA section 4 test rule to require R&D manufacturers and/or small-quantity manufacturers to submit exemption applications" (Ref.69, p. 18882). EPA will also continue toretain the ability to elevate, on a case-specific basis, R&D manufacturers, smallquantity manufacturers, and processors, fromTier 2to Tier 1.The concept that flexibility canbe built into test rules in general is suggested by 40 CFR 790.2, which states inpart that "the procedures for test rules are applicable
to each test rule inpart 799 ofthis chapter unless otherwise stated in specific test rules in part 799 ofthis chapter."

The Agency does not intend to specifically identify all individual Tier 

### 22416

HeinOnline -- 69 Fed. Reg. 22416 2004

### Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

2entities. Rather, these entities would self-identify via the submission of letters ofintent to test or exemption applications. EPA expects that, similar
to the arrangements typically developed when Tier 1entities are under an obligation to conduct testing, ifTier 2 entities are required to conduct testing, it would generally be to theirbenefit to reach agreement on who will actually conduct the testing. The Agency believes that itis unlikely that Tier 2 entities will be required to conduct testing under this final test rule, a view that is shared by ACC which stated that:

[AC] isnot aware ofany substance coveredby thetesting proposal forwhich there is likely tobe noTier 1producer who

comes forward [to conduct testing]. Indeed, ACC is not aware ofany instance in thepast where not a singleperson initiallyrequired to complywitha test rule came forward, suchthatEPA was required to notify other persons oftheir obligations under thetest rule.

EPA intends to follow the procedures laid out in the regulatory text ifit becomes necessary for EPAto call upon persons in Tier 2to conduct testing. In other words, ifEPA does not receive a letter ofintent to test from any Tier 1 entities, the Agency will publish a Federal Register notice to alert Tier 2 entities to the requirement that they submitletters ofintent to test or exemption applications.

3.Donot subdivideTier2 asa general matter,insteadsubdivide Tier2 on a case-by-casebasis.In the proposed rule, EPA solicited comments on subdividing Tier 2to enable the Agency to prioritize which persons in Tier 2would be required to perform testing, ifneeded. ACC and API suggested that EPA should
not subdivide Tier 2entities as a general matter, for all test rules. They commented that, ifEPA considers requiring Tier 2entities to conduct testing, the Agency should first determine whether in fact there are no Tier 1entities, and reevaluate whether the proposed testing is still necessary. If Tier 1manufacturers do not conduct testing and the testing is still necessary, then EPA should identify upfront which persons in Tier 2willbe required to test. ACC suggests that subtiering the Tier 2entities could be done on a caseby-case basis asneeded, based on the activities that give rise to the need for testing. API argues that there isno basis for distinguishing processors from the various types ofmanufacturers included in Tier 2, therefore there isno justification for subtiering the Tier 2 entities.

Despite these comments, and although EPA does not anticipate a need for Tier 2entities to conduct testing under this final rule, EPA has decided
to subdivide the Tier 2entities upfront in this final rule (see Unit V.E.3.e.). Subdividing Tier 2upfront in test rules may facilitate compliance by requiring Tier 2manufacturers, when required to comply, to submit letters ofintent to test

or exemption applications before
processors are called upon to do so. The Agency's expectation is that itmay generally be less administratively complex for manufacturers to conduct the testing (including coordinating efforts to determine who will actually conduct testing) than for processors to do so. This is because there are generally fewer manufacturers (even as byproducts, impurities, etc.) than
processors. EPA alsobelieves that testing costs have traditionally been passed bymanufacturers along to processors, and has not received evidence to the contrary. The Agency does not believe at this time that it can justify a subdivision ofTier 2 entities otherthan between Tier 2 manufacturers andprocessors. For example, EPA does not believe it would be appropriate tobase a subdivision on the activities that give rise to the need for testing (see, e.g., Unit 111.1. 7.).

4. Personswho solelymanufacture and/or processnon-isolated intermediatesornaturally occurring substancesshouldnotbe subjectto rulesunderTSCA section4. Commenters provided several reasons for completely exempting these manufacturers from test rule coverage. Certain commenters believe that these entities have never been covered bytest rules in the past, and were specifically excluded under the amended proposed rule for hazardous air pollutant (HAP) chemicals (Ref.70). These commenters pointed out that non-isolated intermediates are exemptfrom Premanufacture Notification (PMN), the Inventory Update Rule (IUR), PAIR, and general TSCA section 8(a) requirements. One commenter indicated that production ofnon-isolated intermediates does not contribute to the need for testing or present the same

concerns as do other substances introduced into commerce, thus manufacturers ofnon-isolated intermediates should not be considered subject to test rules. Another commenter suggested that EPA has discretion under TSCA section4 to specify the classes of
persons subject to or exempt from a test rule based onits rationale for requiring testing. The comments suggest, however, thatwhere EPA has casespecific justification(s) (for example, chemical-specific hazard or exposure

concerns related to the manufacture of non-isolated intermediates ornaturally occurring substances are demonstrated), these categories ofmanufacturers could be appropriately included as subject to

a rule.

EPA does not believe that itwould be appropriate to fully exempt manufacturers and processors ofnonisolated intermediates andnaturally occurring substances fromrules under TSCA section 4. Instead, itis generally appropriate to include such entities as persons subject to TSCA section 4 test rulesbecause they are considered manufacturers and processors under TSCA and shouldbe included among those responsible for conducting testing

or providing fair and equitable reimbursement to those who have conducted testing. As ageneral matter, however, EPA intends toplace manufacturers ofnon-isolated intermediates and naturally occurring substances inTier 2 intest rules unless, for example, the Agency believes such manufacturers are responsible for a disproportionate share ofthe production volume of atest rule substance, in which case EPA may place them in Tier 1.The plain language ofthe statute indicates that testing responsibilities underTSCA section 4(b)(3)(B) are not restricted to those who manufacture or process a test rule chemical for limited

uses. Noris EPArequired to demonstrate that particular types of manufacturing or processing contribute
to the need for testing (i.e., that a particular type ofmanufacture plays a direct role in increasing risk, in the case ofa rule based on a TSCA section 4(a)(1)(A) finding, orin increasing exposure, in the case ofa rule based on

a TSCA section 4(a)(1)(B) finding). See TSCA section 4(a). The statute indicates that ifEPA finds that the effects associated with manufacture, distribution in commerce, processing,
use, or disposal cannot reasonably be determined or predicted (see TSCA section 4(a)(1)(A)(ii) and 4(a)(1)(B)(ii)), thenmanufacturers and/orprocessors

are generally required to test (see TSCA section 4(b)(3)(B)). Forexample, the final TSCA section 4 rule for biphenyl (Ref. 77, pp. 37184-37185) stated that TSCA section 4 testing responsibilities

are not restricted to only those who manufacture or process atest rule chemical for certain uses. Rather, the persons who manufacture and/or
process (depending on the findings made) atest rule chemical are generally subject to the requirements of afinal test rule.

In order to ensure thatreimbursement ofthe entity(ies) conducting testing is equitable, as a general matter, EPA does 

### 22417

HeinOnline -- 69 Fed. Reg. 22417 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

not believe that itis appropriate for classes ofentities otherwise potentially subject to a rule to be dropped from all rule-related obligations (withthe exception ofpersons who do not know

orcannot reasonably ascertain that they manufacture or process a test rule substance). There may be circumstances, not present here, when it would be equitable to exempt additional entities from alltest rule obligations, but that determination would need tobe made on acase-by-case basis.

Persons who solely manufacture a chemical in the form ofa non-isolated intermediate are generally exempt from the TSCA section 5PMN regulations (40 CFR 720.30(h)(8)), the TSCA section 8(a) IUR (40 CFR 710.30(c)), the TSCA section 8(a)PAIR (40 CFR 712.25(d)(2)), and the general TSCA section 8(a) regulations (40 CFR 704.5(d)) for

reasons particular to those regulations. However, this does not preclude EPA from treating these persons as manufacturers ofchemical substances for purposes of other provisions of TSCA, including TSCA section 4. For example, EPA has stated that:

chemical substances [which are not intentionally removed from the equipment in which they were manufactured] are considered tobe manufactured orprocessed for acommercial purpose for the purposes of section 8oftheAct. (Ref.71, p. 64588).

EPA believes itis generally appropriate
to include manufacturers ofnonisolated intermediates and naturally occurring substances as persons subject
to TSCA section 4 test rules in order to

ensure that reimbursement ofthose who paid the costs oftesting is equitable. TSCA section 4(c)(3)(A) requires EPA to order "fair and equitable" reimbursement for test costs under the Agency's reimbursement regulations. Consistent with this purpose, EPA's
current "persons required to test" approach distributes the burden of testing andreimbursement equitably amongthe persons who manufacture and/orprocess test rule substances, with

an exemption for persons who do not know or cannot reasonably ascertain that they manufacture or process a test rule substance.

Even ifitwere relevant to the question ofwho is subject to a TSCA section4 test rule, EPA disagrees with the assertion that the manufacture of non-isolated intermediates does not present any exposure-related concerns. While the amount ofchemical substance released as a result ofthis type of production may generally be expected
to be less than isreleased as a result of otherproduction, manufacturing or processing a chemical as an intermediate does not preclude
exposure to that chemical. See Office of Solid Waste final test rule (Ref. 72, p. 22305). The production ofnon-isolated intermediates presents concerns related
to acute exposures, from, e.g., spills, leaks or transfers. In addition, as EPA stated in the test rule for Office ofSolid Waste chemicals:

It is common experience thatprocess waste streams andreactor vesselresidues will contain "intermediates." Inmany instances, these chemicals are released tothe environment as fugitive emissions, liquidor solid wastes, and as unreacted feedstock (impurities)in finishedproducts. As such, "intermediates" typically exist as chemicals
to whichthere ispotential forhuman exposure. (Ref. 72, p. 22305).

EPA believes that, although a person's manufacture of achemical in the form ofa non-isolated intermediate may provide a lesser exposure concern than the manufacture by other persons ofthe

same chemical in other forms, an appropriate accounting ofresponsibility is provided for in the determination of fair and equitable reimbursement under TSCA, when necessary. TSCA section 4(c)(3)(A) states that "all relevant factors" must be considered by EPAin the promulgation ofrules for the determination ofreimbursement. Pursuant to this provision, EPA established mechanisms in its general reimbursement ruleto allow, as needed, for the case-specific consideration of factors such as exposure to a chemical

as aresult ofeach subject person's manufacturing and/orprocessing activities. See 40 CFR 791.40(a).

Finally, manufacturers and processors ofnon-isolated intermediates and naturally occurring substances have been subject to test rules in the past, except as proposed in the amended proposals for the testing ofcertain hazardous air pollutants (HAPs). (Ref. 73, pp. 19696, 19699 and Ref.70, pp. 67470, 67481). EPA is not adopting the approach taken in the HAPs proposals for this final rule and, as described in Unit V.E., is taking a different position here. TSCA section 4(a) requires testing iffindings have been made with regard
to certain activities involving chemical substances ormixtures, and, under TSCA section 4(b)(3)(B), manufacturers and/orprocessors must conduct such testing iffindings have been made. TSCA does not distinguish among manufacturers andprocessors of different forms/production types ofa chemical substance ormixture; all are generally subject to the requirements of TSCA section4. 5. "Manufacturers oftestsubstances

ascomponentsofClass2substances" shouldnot beincludedamongthe
personssubjectto thefinalrule.In the proposed rule, EPA stated that manufacturers oftest substances as components ofClass 2 substances wouldbe amongthose entities that wouldbe subject to the final rule, but
notinitially required to comply (i.e., Tier 2). Class 2 substances are chemical substances having a chemical composition that cannot be represented by a specific, complete chemical
structure diagram, because such a substance generally contains two or

more different chemical species (not including impurities) (see 40 CFR 720.45(a)(1)(i)). The Agency received a number of comments debating the appropriateness ofthe proposed Tier 2
status ofmanufacturers ofcomponents ofClass 2 substances.

a. ACC andAPI (Refs. 15 and 19) commented that components of Class 2 substances are not considered under TSCAto have been "manufactured" in their own right unless they have been separated fromthe Class 2 substance.

EPA disagrees. The Agency considers

a substance to be manufactured for
purposes ofTSCA section 4 even ifitis manufactured as a component of another chemical substance, and regardless ofits isolation from other components ofthe combination. EPA maintains that to be regulated under a TSCA section 4 action (for which findings have been made that allow EPA
to cover manufacturers), a manufacturer
mustbe a "manufacturer" as defined by TSCA section 3, andmanufacture a chemical substance (or mixture)that is subject to a testrule. Under TSCA section 3(7):

[t]he term 'manufacture' means to import intothe Customs territory ofthe United States (asdefined in general headnote 2of theTariff Schedules ofthe United States), produce, or manufacture.

There are no limitations in the definition of "manufacture" or in TSCA section 4 to suggest that ifa person imports, produces, or manufactures a test rule substance as part ofa complex combination of substances (i.e., a Class 2 substance), as opposed to an isolated component, then the person is not a manufacturer ofthat test rule substance. Therefore, EPA considers a chemical substance to be manufactured and subject to coverage under TSCA section 4 even ifitismanufactured as a component ofanother chemical substance, and regardless ofits isolation from other components ofthe combination. 

### 22418

HeinOnline -- 69 Fed. Reg. 22418 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

EPA has used the term "Class 2 substance" as a way to describe variable composition substances and complex combinations ofsubstances which can separately be considered "chemical substances" under TSCA. Ifa Class 2 substance is a chemical substance as defined by section 3(2)(A) ofTSCA, then EPA may regulate the Class 2 substance itself. Neither the designation ofa particular substance as a Class 2 substance, norEPA's authority to regulate it as a distinct chemical substance under the Act, changes the fact thatit may contain any number of individual components which may also be "chemical substances" as defined by TSCA, and therefore, alsobe subject to EPA's regulatory authority under the Act. See, especially, TSCA section 3(2)(A), which identifies amongthe set ofsubstances that are "chemical substances":

... any organic orinorganic substance of

a particular molecular identity,including any combination ofsuch substances occurring in whole or in part asaresult ofa chemical reaction oroccurring in nature.. Thus, ifappropriate TSCA section 4(a)(1) findings are made with regard to manufacturing, distribution in
commerce, use, and/or disposal activities for a chemical substance, then manufacturers ofthat substance are subject to the test rule according to TSCA section 4(b)(3), regardless of whether they manufacture the substance

as a component ofa Class 2 substance

orin some other manner.

This is consistent with the position
setforth in the proposed methylcyclopentane (MCP) and commercial hexane test rule, stating that:

..manufacturers and processors ofMCP

orcommercial hexane who do so in the

course ofproducing gasoline orother motor

orheating fuels are subject tothis rule because the Agency's.. .findings arebased on the manufacture, processing, and use ofMCP and commercial hexane. (Ref. 75, p. 17864-17865).
Gasoline is a Class 2 substance; commercial hexane is a Class 2 component ofgasoline and MCP is one ofits C6 isomer components. In the final rule, EPA dropped the testing requirement for MCP, but kept the requirement for manufacturers of commercial hexane, stating that "[i]f health effects are positive for commercial hexane, then EPA may consider testing the C6 components individually" (Ref.76, pp. 3387-3388).

The Agency acknowledges that it has
not explicitly required persons who manufacture test substances as components of Class 2 substances to comply with certain test rules in the past. However, the Agency does believe that these persons are manufacturers for
purposes ofTSCA section 4, and hence

are subject to test rules where appropriate findings are made under TSCA sections 4(a)(1) andin accordance with TSCA section 4(b)(3).

b. ACC (Ref. 15) commented that EPA should clarify that itwill continue to treat Class 2 substances as distinct chemical substances (withcomponents that are not regulated under the PMN and other TSCA regulations) regardless ofthe "persons required to test" approaches taken in the OSHA dermal and HAPs proposed rules.

The approach to the identification of "persons required to test" that is being adopted in this final test rule, and which may be applied in other, future
test rules, is not intended to modify the
status of any chemical substance or entity under other existing TSCA regulations.

c. API (Ref. 19) commented that Tier 2 should include "manufacturers of Class 2 substances thatcontain a test rule substance" rather than "manufacturers ofcomponents ofClass 2 substances."

EPA disagrees with this suggested change, andhas not implemented it in this final rule. The Agency believes it has the authority under TSCA section 4
to regulate both manufacturers ofClass 2 substances themselves (forexample, by requiring the testing ofa Class 2 substance by manufacturers ofthat Class 2 substance) and manufacturers oftest substances as components ofClass 2 substances (for example, by requiring the testing of a chemical substance by manufacturers that produce orimport that chemical substance as a component ofa Class 2 substance). In this final test rule, persons in the former group are included in Tier 1 ofthe grouping of
persons required to test, whereas
persons in the latter group are included in Tier 2. d. API (Ref. 19) commented that manufacturers ofClass 2 substances shouldnot be considered manufacturers ofthe myriad components in the Class 2 substances unless theyisolate a component chemical, for a number of

reasons: * Class 2 substances are distinct chemical substances that are complex and variable in composition, and the Class 2nomenclature is accurate and useful for representing them. * AClass 2 stream may contain a substance as a component at some times but not atothers. * Applying TSCA rules to Class 2 substances, rather than to their individual components, does not compromise protection ofhuman health and the environment.

* Because many components of Class 2 substances do not add commercial value to the products, manufacturers ofClass 2 substances may notbe aware ofthe presence oftest rule substances as components.

As stated in Unit III.I.5.a., EPA does
not agree that manufacturers of components ofClass 2 substances should onlybe regulated under TSCA section 4 ifthey isolate a component substance that is subject to the test rule. TSCA section 4(b)(3)(B) generally provides the authority for the Agency to include allmanufacturers and/or
processors in the scope oftest rules, regardless ofwhether they isolate atest rule substance from a Class 2 substance.

The inclusion ofmanufacturers oftest substances as components ofClass 2 substances as persons subject to this final test rule isnot intended toreflect any finding, or determination on the part ofEPA that there is a direct connection between a specific manufacturing activity and the potential human health and/or environmental hazards or risks that maybe associated with the testrule substance. See also biphenyl final testrule (Ref.77, pp. 37184-37185). Their inclusion as persons subject to the ruleis intended
to facilitate the fair and equitable distribution ofburden oftesting and reimbursement among the persons who manufacture and process test rule substances. For example, there may be

cases where large quantities ofa component ofa Class 2 substance are manufactured, such that the quantity of

a particular non-isolated component (thatis the subject ofa TSCA section 4
test rule)is far greater than the quantity ofthe same chemical substance manufactured in isolatedform by other
persons.

The concern that "because many components ofClass 2 substances do
not add commercial value to the products, manufacturers of Class 2 substances may notbe aware ofthe
presence oftest rule substances as components" is addressed bythe provision inthis final test rule which exempts persons from testing obligations where their status as manufacturers or processors ofa particular substance isnot "known to or reasonably ascertainable by" them.

In response to the comment noting thatpersons may be aware ofthe
presence ofa component of aClass 2 substance in a stream at some times but
not others, EPAbelieves that the reimbursement process under TSCA 

### 22419

HeinOnline -- 69 Fed. Reg. 22419 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

section 4 and the implementing regulations at 40 CFR part 791 address the concern; under these provisions, if utilized, persons wouldbe required to provide fair and equitable contributions

to test costs. The circumstance of a substance that is known to be produced

at only certain times and not others may be a consideration under that process.

e. API (Ref. 19) commented that requiring manufacturers ofClass 2 substances to test components ofClass 2 substances that are also test substances would be a departure from past regulatory practice under TSCA section 4.

EPA disagrees with the commenter's

statement that requiring manufacturers ofClass 2 substances to test components that are also test substances that the
person manufactures would be a departure from past regulatory practice under TSCA section 4. EPA acknowledges that in general its past practice has not been to impose explicit obligations under TSCA section 4 on persons who manufacture a test substance as a component ofa Class 2 substance, unless that person isolates the test substance from the Class 2 substance, although as discussed in Unit III.I.5.a., there have been exceptions.

However, EPA did not explicitly require testing by manufacturers oftest substances as components of Class 2 substances in certain previous test rules in part because EPA had determined in light of comments received on the proposals that testing of the Class 2 substance itselfwould be more appropriate than requiring testing on the individual components of Class 2 substances. See the discussion ofthe commercial hexane test rule (Ref. 76) in Unit III.I.5.a. In another case, EPA declined to require testing by manufacturers ofcomponents ofClass 2 substances in a final test rule because it believed that it had provided insufficient notice that such manufacturers would be subject to the
test rule. See the clarification to the final test rule covering certain "Office of Water chemicals" (Ref. 78).

As discussed previously, however, TSCA sections 4(c)(3)(A) and 4(c)(4)(A) require EPA to order, where necessary, "fair and equitable" reimbursement from manufacturers and processors for

test costs incurred by those who are developing, or who have submitted the required test data. EPA believes that fairness and equity can be best facilitated by including within the pool ofpersons from whom reimbursement

can potentially be sought all persons who can be considered manufacturers or processors under TSCA, subject to

narrow, clear exemptions. EPA believes that persons who manufacture test substances as components ofClass 2 substances are "manufacturers" under TSCA section4, andgenerally should
not be exemptfrom inclusion among those from whom reimbursement could potentially be sought. 6. Createademinimis exemption. API suggests that EPA provide a de minimis exemption like the exemption provided in the amended proposed HAPs rules (Ref. 70, pp. 67470, 67481 and Ref. 73, pp. 19696, 19699) for manufacturers andprocessors who solelymanufacture or process test rule chemicals in amounts less than 1%in

amixture.

EPA is not adopting this suggestion in this final rule. The final rule contains an exemption from all responsibilities associated with the final rule for
persons who donot know or cannot reasonably ascertain that they manufacture or process atest rule substance. The final rule also provides Tier 2 status to manufacturers of smallquantities (less than 500 kg/1,100 lb per year or solely for R&D), those who manufacture the test substance as a byproduct, impurity, naturally occurring substance, non-isolated intermediate, or component of aClass 2 substance, and all processors. With respect to manufacturers of small quantities who manufacture the test substance as a component ofa Class 2 substance, the 500 kg/1,100 lb cutoff applies to the manufacture ofthe test substance, not the Class 2 substance. EPA believes that these provisions supply sufficient relieffrom test rule requirements to lower volume manufacturers andprocessors. These groups are still subject to reimbursement, however, and they would alsopotentially be subject to testing.

To the extentthat persons who manufacture a test rule chemical in
amounts less than 1%in a mixture are not covered by the "known to or reasonably ascertainable by" exemption, and are not otherwise included in Tier 2,they are initially required to comply with the final test rule. EPA believes that Tier 1 status is appropriate for these manufacturers, who produce or import
atleast 500 kg/1,100 lb ofa test rule chemical each year, and who know (or who could reasonably ascertain) that they are manufacturing the chemical. 7. In determiningwho isresponsible forconductingtesting,EPA should considerthedataneeds the ruleis intendedtofill andtheroleofspecific manufacturingand processing activities in creatingtheexposurescenariosthe ruleis intendedto evaluate.ACC commented that under TSCA section 4(b)(3)(B), responsibility for conducting testing maybe imposed onthose manufacturers and/or processors engaged in activities for which EPAhas determined that available data and experience are insufficient under TSCA section 4(a). Thus, EPA's approach to the "persons required to test" section in

a given test rule should depend on the data needs the ruleis intended to fill, and the role ofthe specific manufacturing andprocessing activities in creating the particular human or environmental exposure scenarios which the ruleis intended to evaluate.

TSCA does not limitthe persons subject to a testrule solelyto specific classes ofmanufacturers and/or processors based on the data needs the rule is intended to fill, or based on the role ofthe specific manufacturing and processing activities in creating particular exposures. Rather, persons who manufacture and/orprocess (depending on the findings made) a test rule chemical are generally subject to the requirements ofthe test rule. TSCA section 4(b)(3)(B). See alsobiphenyl final test rule (Ref. 77, pp. 37184- 37185), which states that testing responsibilities underTSCA section 4

are not restricted to only those who manufacture or process atest rule chemical for certain uses.

EPA agrees that certain limited exemptions for persons who would otherwise be subject to testrules may be appropriate. However, in order to fully exempt agroup ofpersons otherwise covered by a test rule from responsibilities underthe test rule, EPA's view is that there must be an adequate justification for doing so that is consistent with the intent ofthe statute, and that is applicable onlyto those persons who itis proposing to exempt, and not any others. For example, in this final rule EPA is exempting manufacturers and
processors who "do not know or cannot reasonably ascertain" that they are manufacturing or processing a test rule chemical (see §799.5115(b)(2) ofthe regulatory text).

Exempting individual entities or classes ofentities from test rule requirements onthe basis of a determination that their activities do not relate in some direct way to the data needs the rule is intended to fill or to the exposure scenarios addressed bythe rule is not consistent with the intent of the statute. Such exemptions would likely resultin the need for multiphase rulemaking, andmay inmost cases not be possible from a practical standpoint given that EPA often would not have enough information to make such determinations. In addition, exempting 

### 22420

HeinOnline -- 69 Fed. Reg. 22420 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

certain individual entities orclasses of entities from test rule requirements increases the potential that the burden oftesting and reimbursement would be distributed in an inequitable manner amongthe persons who manufacture andprocess test rule substances. The Agency believes itis appropriate to generally require manufacturers and/or
processors of a test rule chemical tobe subject to a rule, rather than to fully exempt individual manufacturers or processors or certain classes of manufacturers orprocessors from test rule responsibilities.

8. Tier2shouldnotbe subjectto reimbursement.AFPA, API, ACC/O, ACC/KO, and ACC commented that subjecting Tier 2entities to reimbursement would, in large part, eliminate the benefit associated with having a tiered approach. EPA should onlyrequire Tier 2 entities to reimburse ifthey are required to conduct testing in the absence oftesting commitments from Tier 1 entities.

EPA does not agree. In order to ensure that test sponsors have the ability to seek equitable reimbursement, Tier 2 entities are subject to reimbursement regardless ofwhether the entities included in Tier 1complete the testing required under the rule. EPA addressed this issue in the context ofits May 7, 1990 rule amending the testing procedural rule by adding certain groups ofmanufacturers to Tier 2.EPA stated the following in the final rule:

Some commenters suggested that chemicals produced solely forR&D [research and development] purposes shouldbe excluded altogether fromTSCA section 4 rules. Thus, rather than placing R&D manufacturers in a "second tier," they would notbe legally subject unless specified in a particular testrule... EPA doesnot believe that it should grant atotal exemption toR&D manufacturers. TSCA section 4 givesEPA authority torequire testing ofchemicals manufactured forR&D. Congress did not exempt R&Dmanufacturers from being subjectto TSCA section 4, as inthe case of [rules under] sections 5or 8ofTSCA. Inthis rule, EPA haslifted the procedural burden imposed on R&Dmanufacturers bytest rules, recognizing that test sponsors would rarely, ifever, seekreimbursement fromR&D manufacturers. By maintaining legal authority over R&Dmanufacturers, however, EPA hasreserved theright ofatest sponsor to seekreimbursement fromall persons legally subject toatest rule. (Ref.69, p. 18883).

The final rule amending the testing procedural rule indicates thatpersons in Tier 2 are subject to the requirement to conduct testing under a test rule during the period from the effective date ofthe
test rule to the end ofthe reimbursement period, but will not generally be required to submit letters of intent to test or exemption applications unless no other manufacturer ofthe chemical submits aletter ofintent to test (Ref.69, p. 18882). In addition,
persons in Tier 2willbe required to submitletters ofintent to test or exemption applications ifa problem

occurs with the initiation, conduct, or completion ofthe required testing orthe submission ofthe required data with respect to a chemical substance included in the test rule.

However, although Tier 2 entities are subject to providing reimbursement, EPA's experience under previous test rules has been thatpersons who manufacture the largest quantities ofa test rule substance have generally found it to be in their best interest to develop cost-sharing arrangements (which typically donot include all persons subject to providing reimbursement) to

cover the costs oftesting, rather than attempting to reach an agreement regarding reimbursement among the broader group made up ofall persons potentially subject to providing reimbursement, or soliciting the involvement ofthe Agency under the reimbursement regulations at 40 CFR part 791 in developing a reimbursement arrangement. The development of such private cost-sharing arrangements appears to avoid possible difficulties that could be associated with coordinating the larger group ofall
persons potentially subject to reimbursement under atest rule, and provides flexibility to the parties to the arrangement because it may take any form they choose. Ifthe parties are unable to agree upon acost-sharing arrangement, they may contact EPA and initiate formal reimbursement procedures under 40 CFR part 791. These procedures would include all
persons subject to the rule, i.e., all entities from both Tier 1 and Tier 2.

Other comments related to the issue ofreimbursement byTier 2entities are listed below:

a. Persons not initially required to comply with atest rule have never been required to reimburse before (ACC, ACC/O, API). EPA disagrees. Since 1990, EPA has included processors, small-quantity manufacturers (i.e., manufacturers ofless than 500 kg (1,100 lbs.) ofa test rule chemical), andR&D manufacturers in Tier 2 (See 40 CFR 790.42(a)(2), 40 CFR 790.42(a)(4), and 40 CFR 790.42(a)(5), respectively). As a result, for the last decade these entities have been considered subject to test rules, but not initially required to comply with the requirement that letters ofintent to test or exemption applications be submitted to EPA. Shifting groups ofmanufacturers and/or processors to Tier 2does not "change the legal rights and obligations of
persons subject to TSCA section 4 test rules, but would only eliminate some of the paperwork burden associated with compliance." (Ref.69, p. 18882). Infact,
persons included in Tier 2 "would still be subject to testrules (and export notification requirements as specified in TSCA section 12(b)), andwould not be exemptfrom reimbursement claims." (Ref.69, p. 18882).

The Agency shifted R&D and smallquantity manufacturers to Tier 2based

on its recognition that, in practice, the administrative costs of seeking reimbursement fromthese entities would likely exceed the reimbursement that might be gained by their participation. Therefore, the filing of exemption applications by R&D and small-quantity manufacturers serves no practical purpose (i.e., there is noneed for them to self-identify by submitting exemption applications). As discussed in the proposed rule, processors were originally putin Tier 2for another
reason, i.e., manufacturers would not likely seek reimbursement directly from them,but wouldrather pass their costs

on to processors indirectly via the market. In addition, the large numbers ofprocessors would create administrative difficulties in making testing decisions (Ref.5, p. 31081).

Persons who are subject to a testrule, but who are not initially required to comply with the test rule have always been potentially subject to reimbursement under the formal reimbursement procedures at 40 CFR part 791. For example, see the interim final rule amending the procedural rule
at40 CFR part 790 (Ref. 74, p. 20654), which states that,where manufacturers and processors are subject to a testrule, processors will automatically be given a conditional exemption from the requirement that letters ofintentto test

or exemption applications be submitted
to EPA. This exemption is conditional because itwould be lifted ifnone ofthe
persons initially required to comply with the rule (i.e., manufacturers) submit a letter ofintent to test. In addition,processors maybe required to provide reimbursement directly to those sponsoring the testing.

Although Tier 2entities are subject to reimbursement under this final test rule and havebeen subject under past test rules (see final rule amending the testing procedural rule at 40 CFR part 790 (Ref.69), EPA believes thatthey have not historically participated in reimbursement because other manufacturers have always created cost22421

HeinOnline -- 69 Fed. Reg. 22421 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

sharing arrangements that did not require their involvement.

b. Tier 1manufacturers should be those persons who undertake the activities that, for the mostpart, give rise to the need for testing. As a result, they shouldbe the only ones responsible for reimbursement. EPA shouldidentify upfront in a rule the persons whose activities warrant their contribution to the cost oftesting. All of these persons shouldbe included in Tier 1, and reimbursement should only apply to those Tier 1persons (unless EPA has to resort torequiring entities in Tier 2to submit letters ofintent to test/ exemption applications, and then Tier 2 would have to reimburse also) (API). Entities in Tier 1that obtain an exemption in lieu oftesting should generally be the onlypersons responsible for reimbursing. EPA should retain flexibility to impose costs on Tier 2entities when circumstances warrant (ACC, ACC/O).

Under TSCA section 4(b)(3)(B), once EPA has made the requisite regulatory findings with respect to a chemical, "each person" who manufactures (or intends to manufacture) and/or
processes (orintends toprocess) the chemical "shall" be required to conduct
tests and submit data. Tier 2entities have "automatic conditional exemptions" from the requirement that they conduct testing (see §799.5115(c)(3) ofthe regulatory text). TSCA sections 4(c)(3) and 4(c)(4) indicate that persons granted exemptions from the requirement that testing be conducted and data submitted
may be required to reimburse the costs oftesting under reimbursement regulations promulgated bythe Agency ifthe persons subject to the rule do not otherwise agree onthe amount and method ofreimbursement. As a result, although EPA initially exempts Tier 2 entities from requirements associated with testing and the submission ofdata, these entities are not exempt from the requirement that theyreimburse the
costs oftesting.

EPA does not believe TSCA provides flexibility to impose reimbursement obligations onTier 2entities only when it makes a determination that the circumstances warrant it, or based on determinations as to whether particular manufacturers/processors or specific groups ofsuch entities undertake activities that relate directly to the rationale for requiring testing. TSCA section4 indicates that testing responsibilities are not restricted to those who manufacture or process a test rule chemical in certain forms (suchas restricting the requirements ofthe rule onlyto Tier 1entities). Rather, persons who manufacture and/orprocess (depending on the findings made) a test rule chemical are generally subject to the requirements of afinal test rule. TSCA section 4(b)(3)(B). See also biphenyl final test rule (Ref. 77, pp. 37184-37185). EPA has created an exception to this general approach solely for persons who do not know or who cannot reasonably ascertain that they manufacture and/orprocess a test rule chemical.

c. Reimbursement requirements should only apply to persons who may be required to conduct tests and submit data, i.e., Tier 1 (ACC).

All persons included in either Tier 1

orTier 2may be required toreimburse the costs oftesting because all manufacturers andprocessors ofthe chemical substances included in this final test rule are subject to the final test rule. As the reimbursement regulations (promulgatedpursuant to TSCA section 4(c)(3)(A)) provide: "[p]ersons subject to

atest rule have an obligation

...either
to test or to obtain an exemption and
pay reimbursement" (40 CFR 791.2(a)). Tier 2 entities have automatic conditional exemptions from testing requirements, as discussed earlier. Although Tier 2entities are not as likely
to be required to conduct testing as Tier 1entities, both groups are responsible for reimbursing the person(s) who actually conduct testing.

d. EPA's proposed extension of reimbursement obligations to Tier 2 entities might complicate future efforts
to conduct testing under ECAs (ACC, ACC/O).

EPA is not significantly changing the
status quo with regard toreimbursement obligations established under previous TSCA section4 regulations. Persons in Tier 2under previous test rules have been subject toproviding reimbursement. See the final rule amending the testing procedural rule at 40 CFR part 790 (Ref.69). The primary effect ofthe approach to "persons required to test" that was proposed and is being adopted in this final rule is to better focus the set ofpersons included in Tier 1, and to expand and clarify the
set ofpersons included in Tier 2.EPA is unaware of any reason to believe that this approach to "persons required to test" will make itmore difficult to develop ECAs.

e. EPAhas said that manufacturers of impurities, byproducts, and components ofClass 2 substances have not historically participated in testing or reimbursement. This istrue ofall other entities included in Tier 2under this final rule. Extending reimbursement to Tier 2 disregards this experience (ACC, ACC/O). EPA agrees that manufacturers of impurities, byproducts, components of Class 2 substances, and all other entities included in Tier 2under this final rule haveprobably nothistorically participated in testing or reimbursement. However, the likely

reason they have notparticipated is because the costs oftesting under test rules promulgated to date have been contributed toby a smaller group of entities subject to the rule (the larger manufacturers ofeach test rule substance), without the need for EPA's involvement. EPA anticipates that similar cost-sharing arrangements would continue to occur underthis final rule and other rules using this revised approach to "persons required to test,"

as they offer significant advantages to the persons subject to the rule. IfEPA

were tobecome involved in reimbursement via the reimbursement procedures at 40 CFR part 791, then all Tier 1 andTier 2manufacturers and processors would be included in those proceedings.

9.EPA shouldclarifythatthe approaches to the "personsrequired to test" sectionsin the OSHA dermaland HAPsproposedrules willnotaffect the applicability ofrequirementsunder TSCA programsoutsidethose implementingTSCA section4. ACC/O and ACC commented that where a particular group (e.g., manufacturers of non-commercial byproducts) is currently exempt under certain TSCA regulations, it should continue tobe exemptunder those regulations regardless ofthe "persons required to test" approach taken in test rules under TSCA section 4.

The approach the Agency takes in the "persons required to test" portion of any given test rule is not intended to affect the status ofpersons under regulations other thanthose relevant to the given
test rule.

J.EconomicImpactAnalysis

API noted that EPA's Economic Impact Analysis estimates administrative costs only for companies initially required to comply with the final test rule (companies in Tier 1). API believes that this analysis is inappropriate ifEPApursues imposing reimbursement obligations on Tier 2 entities. Ifreimbursement obligations

are imposed on Tier 2companies, API
asserts there will be associated administrative, negotiation, and other
costs that EPA shouldinclude in its analysis.

EPA disagrees with this comment. Although Tier 2entities are subject to reimbursement, EPA's experience under past test rules has been that Tier 1 

### 22422

HeinOnline -- 69 Fed. Reg. 22422 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

persons have found itto be in theirbest interest to develop cost-sharing arrangements among themselves to

cover the cost oftesting. The development of suchprivate costsharing arrangements appears to avoid possible difficulties that could be associated with coordinating a larger group ofpersons subject to reimbursement under atest rule, and provides maximum flexibility to the parties to the arrangement. Because manufacturers in Tier 1have been identified for each subject chemical (see discussion ofeconomic analysis in Unit VIII. (Ref. 57)), EPA expects that at least

one such person will comply with the testing requirements. EPAis not aware ofany circumstances in which Tier 1 entities have soughtreimbursement from Tier 2 entities either through private agreements or by soliciting the involvement ofthe Agency under the reimbursement regulations at 40 CFR part 791. Given this consistent experience with previous TSCA testing actions, EPA does not believe that there will be any administrative, negotiation,

orany other costs associated with seeking reimbursement from Tier 2 companies.

K.DefinitionofSmallBusiness

In the preamble ofthe proposal to this rule (Ref.5), EPArequested comment on whether the Agency should establish an alternative smallbusiness definition to

use in the small entity impact analyses for future TSCA section 4(a) test rules, and what size cutoffmay be appropriate.

SOCMA commented that the most appropriate definition to use in conducting small entity analyses for TSCA section 4(a) test rules is the employee-based definition established by the U.S. Small Business Administration (SBA), which for most industries classifies firms as small based

onthe number ofemployees in the firm. The SBA set the numerical threshold for what is considered small on an industry-by-industry basis. SOCMA believes that this definition provides EPA with a straightforward and appropriate distinction between small and large companies that are closely related to a company's total annual sales. SOCMA also commented that it does not believe that an alternative approach, such as the small business definition from TSCA section 8 would be appropriate for conducting impact analyses for TSCA section 4(a) test rules. However, SOCMA believes ifEPA

were topursue a sales volume-based definition of"small business," an appropriate level would be, at a minimum, atotal annual sales of$100 million.

EPA did use SBA's size criteria, which SOCMA statedit prefers, in its economic analysis for this final rule. Based onthe SBA definitions, EPAhas concluded that there are no significant impacts on small entities (Ref.57). Regarding SOCMA's second comment, EPA notes that SOCMA did not provide its reasoning as to why it considers a definition of small business based ona combination ofrevenue and production volume inappropriate, nor did it provide any research orjustification as to why an appropriate level ofannual sales used in such a definition should be set ata minimum of$100 million.

As a more general matter, EPA disagrees with SOCMA's position that the SBA small business size standards

are the most appropriate to use in analyzing the impacts ofTSCA section 4 testing rules. The Regulatory Flexibility Act (RFA) of 1980, as amended bythe Small Business Regulatory Enforcement Act (SBREFA) of1996, requires that special consideration be given to small businesses affected byproposed Federal regulations. The SBA size standards, which are primarily intended to determine whether abusiness entity is eligible for government programs and preferences reserved for small businesses (13 CFR 121.101), "seek to

ensure that a concern that meets a specific size standard is not dominant in its field ofoperation." (13 CFR 121.102(b)). See section 632(a)(1) ofthe Small Business Act. Section 601(3) of RFA establishes as the default definition of"small business" the definition used in section 3 ofthe Small Business Act, 15 U.S.C. 632, under which the SBA establishes small business size standards for each industrial sector using an employment threshold that entities in that sector may not exceed to be classified as small. (13 CFR 121.201). RFA recognizes that itmay be appropriate at times to use an alternate definition of small business for the
purpose ofanalyzing potential regulatory impacts. As such, section 601(3) ofRFA provides that an agency may establish adifferent definition of small business afterconsultation with the SBA Office ofAdvocacy and after notice and an opportunity for public
comment.

When assessing the potential impacts oftest rules on chemical manufacturers, EPA believes that a standardbased on total annual sales may provide amore appropriate means tojudge the ability of

a chemical manufacturing firm to support chemical testing without incurring significant costs orburdens. Therefore, EPA is currently determining what levels of annual sales would provide the most appropriate size cutoff with regard to various segments ofthe chemical industry usually impacted by TSCA section 4(a)test rules. EPA may propose, following conclusion ofits analysis, that an alternative definition based on sales be established in accordance with section 601(3) ofthe RFA.

IV.Findings

A. What is theBasis forEPA'sFinal Ruleto Test These Chemical Substances?

As indicated in Unit II.B., in order to promulgate a rule under TSCA section 4(a) requiring testing ofchemical substances ormixtures, EPA must make certain findings for those chemical substances ormixtures regarding either hazard (TSCAsection 4(a)(1)(A)(i)); or exposure (TSCA section 4(a)(1)(B)(i)). EPA is requiring testing ofthe chemical substances included in this final rule based onits findings under TSCA section 4(a)(1)(B)(i) relating to "substantial production" and "substantial human exposure," as well

as findings under TSCA sections 4(a)(1)(B)(ii) and (iii). The chemical substances included in this final rule

are listed in §799.5115(j) ofthe regulatory text along with theirCAS numbers.

In EPA'spolicy for making findings underTSCA section 4(a)(1)(B)(i) (i.e., the "B" policy), "substantial production" of a chemical substance or mixture is generally interpreted to be aggregate production (including import) volume equaling or exceeding one millionpounds per year (Ref.55, p. 28746). The general "B" policy threshold for "substantial human exposure" ofworkers is the exposure of 1,000 workers annually to a chemical substance or mixture (Ref.55, p. 28746). See EPA's "B" policy (Ref.55) for further discussion on how EPA generally makes decisions under TSCA section 4(a)(1)(B)(i).

EPA finds that, underTSCA section 4(a)(1)(B)(i), each ofthe 34 chemical substances included in this final rule is produced in "substantial quantities" and there is or maybe "substantial human exposure" to each chemical substance (Ref.56). In addition, under TSCA section 4(a)(1)(B)(ii), EPA believes that there are insufficient data and experience to reasonably determine

or predict the effects ofthe manufacture, processing, or use ofthese chemical substances, or of any combination of such activities, on human health or the environment. Inparticular, as discussed 

### 22423

HeinOnline -- 69 Fed. Reg. 22423 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

in Unit IV.D., EPA has determined that there are insufficient in vitrodermal absorption rate data on these chemicals. EPA also finds that testing ofthe 34 chemical substances is necessary to develop such data (TSCA section 4(a)(1)(B)(iii)) (see Unit MVE.). EPAhas
not identified any "additional factors"

as discussed in the "B" policy (Ref. 55, p. 28746) to cause the Agency to use decision making criteria other than the general thresholds described in the policy withrespect to the chemicals included in this final rule.

B.Are These ChemicalSubstances Producedand/or Importedin SubstantialQuantities?

Each ofthe chemical substances included in this final rule is produced and/or imported in an amount equal to

orgreater than one million pounds per year (Ref.57), based on information gathered pursuant to the 2002 TSCA section 8(a)IUR (40 CFR part 710). The IUR is the most recently available compilation ofTSCA Inventory data, and is contained in the TSCA Chemical Update System. EPAbelieves that these annual production volumes are "substantial" as that term isused with reference toproduction in TSCA section 4(a)(1)(B)(i) (Ref.55).

C.Are a Substantial NumberofWorkers Exposedto These Chemicals?

EPA finds that the manufacture, processing, and use ofthe chemical substances included in this action result

ormay result in exposure to a substantial number ofworkers. These chemical substances are used in a wide variety ofindustrial applications which result in potential exposures to workers,

as described in the exposure support document for this final rule (Ref. 56).

EPA defines human exposure as the
contact with a chemical or agent at the visible exterior ofa person (i.e., skin and openings into the body such as mouth and nostrils) (Ref.58, p. 22891). Worker exposure is the human exposure to a chemical or agent that occurs while

aperson is working. Worker exposure may have various causes, with chemical releases being a common cause of
exposure. Chemical manufacturing and processing plants can release chemicals from pumps as fugitive emissions, from
reactor and condenser vents as stack emissions, in the form ofa vapor and/

oras a particulate. Diffusion and air
currents may carry achemical throughout the plant and workers may breathe air containing the chemical, resulting in exposures. Certain human activities such asmanually transferring

a chemical from one container to another may also cause exposures. Each ofthe chemicals in this final rule was identified in the NOES as having a total worker exposure of1,000 workers or more (Ref.56). EPA believes that an exposure of1,000 workers or

more to a chemical substance is or may be "substantial" as that term isused with reference to "human exposure" in TSCA section 4(a)(1)(B)(i) (Ref.55).

D.DoSufficientDataExistforThese ChemicalSubstances?

As discussed in this preamble, dermal absorption rate is an important factor in ascertaining the health effects ofthe 34 chemicals in this final rule. EPA has determined that for the 34 chemicals for which in vitrodermal absorption rate testing is required under this final rule, there is either no dermal absorption rate information available orwhere there is

some information, these data are insufficient to estimate dermal absorption rate. Therefore, existing data

are insufficient to reasonably determine

orpredict the human health effects that
may result from dermal exposures to the chemical substances included in this final rule during the manufacturing, processing, oruse ofthe subject chemical substances. This finding is based onthe review and analysis of relevant databy the ITC (which included EPAparticipation), as described in Unit II.A.

E.Is TestingNecessary forThese ChemicalSubstances?

EPA believes that the testing ofthese 34 subject chemical substances is
necessary to determine ifthe manufacturing, processing, or use of these chemical substances may present

an unreasonable risk ofinjury to human health. In particular, the testing required by this final rule will provide dermal absorption rate data which OSHA can consider together with toxicity data to evaluate the need for skindesignations which are used toprotect against potential health risks associated with
exposures to these chemicals in the workplace. See Unit III.B.3. for a detailed description ofthis and other data needs that will be filled by the testing required bythis final rule.

V. Final Rule

A. What Testing isRequiredbythis Action?

EPA is specifying testing and reporting requirements for the chemical substances listed in Table 2in §799.5115(j) ofthe regulatory text according to the in vitro dermal absorption rate test standard set forth in §799.5115(h) ofthe regulatory text. The test standard that will be used underthis final rule was refined as described in Unit III.B. ofthe proposed rule (Ref.5). In addition, certain modifications which added flexibilityto the test standard have been made in
response to comments submitted to EPA and addressed in UnitIII.E.2. ofthis final rule.

B. When Will the TestingImposedby thisFinal Rule Begin?
Once this final rule is effective, which willbe 30 days after its publication in the Federal Register, the required testing mustbe initiated at a time sufficient to allow the final report to be submitted by the deadline indicated in §799.5115(i) ofthe regulatory text, i.e., 13 months after the effective date ofthe final rule.

C.HowMustthe StudiesRequired Underthis TestRulebe Conducted?

Persons required to comply with this final rule must conduct the necessary testing in accordance with the testing and reporting requirements described in the regulatory text, and with the TSCA Good Laboratory Practice Standards (GLPS) (40CFR part 792). Clarification

was provided in the test standard concerning how data shouldbe reported. The clarification indicates that

means and standard deviations must be usedwhen reporting the required determinations. Although the test standard in the proposed rule would haverequired three separate determinations for each chemical (i.e.,

one each for Kp, 10-minute, and 60- minute short-term dermal absorption rates), reporting each as a mean and standard deviation was not specified. However, good scientific practice would suggest that the determinations be reported in this way, and EPAbelieves that this clarification does not substantively change the reporting requirements or theirburden and costs (Ref.57).

D. WhatSubstancesWill be Tested UnderthisFinal Rule?
The "Class 1" chemical substances listed in Table 2in §799.5115(j) ofthe regulatory text (i.e., 32 ofthe 34 chemical substances included in this final rule) must be tested at a purity of
atleast 99%. The term Class 1 chemical substance refers to a chemical substance having a chemical composition that consists of a single chemical species (not including impurities) that can be represented by a specific, complete
structure diagram. Inthose instances in which the test sponsor(s) believes that a 99% level ofpurity is unattainable for

a given chemical, the sponsormay 

### 22424

HeinOnline -- 69 Fed. Reg. 22424 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

request a modification under the procedures described in 40 CFR 790.55.

For the "Class 2" chemical substances listed in Table 2in §799.5115(j) ofthe regulatory text (i.e., 2 ofthe 34 chemical substances included in this final rule), EPA is requiring that the substance to be tested be any representative form ofthe chemical substance.

In providing a different approach for identifying the substance tobe tested with regard to Class 2 substances, EPA recognizes two characteristics which further distinguish Class 2from Class 1 chemical substances. First, unlike Class 1 substances, knowledge ofthe composition ofcommercial Class 2 substances can vary in quality and specificity from substance to substance. The composition ofthe chemical species which comprise a Class 2 substance may be:

* Well characterized in terms of molecular formulae, structural diagrams, and compositional percentages of all species present (for example, methyl phenol);

* Less well-characterized, for example, characterized onlyby molecular formulae, nonspecific structural diagrams, and/orby incomplete orunknown compositional percentages ofthe species present (for example C12-C 14 tert-alkyl amines); or

* Poorly characterized because all that is known is the identity of only

some ofthe chemical species present and their percentages ofcomposition, or ofonly the feedstock and method used
to manufacture the substance (for example, nut shell liquors ofcashews).

Second, the composition of some Class 2 substances may vary from one manufacturer to another, or, for a single manufacturer, from production run to production run, because ofsmall variations in feedstock, manufacturing methods, or other production variables. A "Class 2" designation mostfrequently applies to a substance consisting ofa combination ofdifferent chemical species that are either structurally similar or related bybeing formed together when a certain chemical reaction orprocess is carried out on a certain chemical feedstock. Small variations in the feedstock or in chemical production methods or conditions can account for the types of small variations in composition typically allowable within a given Class 2Inventory listing. By contrast, a "Class 1" designation generally applies to a substance which is an individual chemical whose onlyvariables are its impurities and byproducts.

EPA believes that, for purposes ofthis final rule which would require the determination ofa Kp andtwo in vitro short-term dermal absorption rates, the testing ofany representative form ofa subject Class 2 substance would be relevant to a determination ofwhether the chemical substance would or would
not present an unreasonable risk to human health. However, EPA would encourage the selection of representative forms ofthe test substances that meet industry or

consensus standards, where they exist. In accordance with TSCA GLPS at40 CFR part 792, the final study report must include test substance identification information, including
name, CAS No., strength, purity, and composition, or other appropriate characteristics. (See 40 CFR 792.185).

E.Am IRequiredto Test Underthis Final Rule?
Under TSCA section 4(a)(1)(B), EPA finds that there are insufficient data and experience to reasonably determine or predict health effects resulting from the manufacture, processing, oruse ofthe chemical substances listed in this rulemaking. As a result, under TSCA section 4(b)(3)(B), manufacturers and
processors ofthese substances are subject to the final rule with regard to those listed chemicals which they manufacture or process.

1.Am Isubjectto this final rule?You

are subject to this final rule and maybe required to test ifyou manufacture (whichis definedby statute to include import) or process, or intend to manufacture or process, one ormore chemical substances listed in Table 2in §799.5115(j) ofthe regulatory text duringthe time period discussed in Unit V.E.2. However, ifyou do not know or cannot reasonably ascertain that you manufacture orprocess a listed
test substance (based onall information in your possession or control, aswell as allinformation that areasonable person similarly situated might be expected to possess, control, or know, or could obtain without an unreasonable burden), you are not subject to the final rule forthat listed substance.

2. When will mymanufactureor processing(ormy intentto do so)cause

me tobe subjectto this final rule?You

are subject to this final rule ifyou manufacture or process, or intend to manufacture or process, a substance listed in Table 2in §799.5115(j) ofthe regulatory text at any time from the effective date ofthe final test rule to the end ofthe test cost reimbursement period.

The term reimbursement periodis defined at 40 CFR 791.3(h) andmay vary in length for each substance tobe testedunder a final TSCA section 4(a)
test rule, depending on whattesting is required and when testing is completed. (See UnitV.E.4.).

3. Will Ibe required to testifIam subjectto the final rule?It depends on the nature ofyour activities. All persons who are subject to this TSCA section 4(a) testrule, which, unless otherwise noted in the regulatory text, incorporates EPA's generic procedures applicable to TSCA section 4(a) test rules (contained within 40 CFR part 790), fallinto one oftwo groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who must initially comply with the final rule)
must either: Submit to EPA letters of intentto conduct testing, conduct this testing, and submit the test data to EPA

or apply to and obtain from EPA exemptions from testing. Persons in Tier 2 (thosewho do not have to initially comply with the final rule)need not take any action unless they are notified by EPAthat they arerequired to do so,

as described in Unit V.E.3.d. Note that
persons in Tier 1who obtain exemptions and persons inTier 2 are nonetheless subject to providing reimbursement to persons who actually conduct the testing, as described in Unit V.E.4.

a. Who is in Tieri andTier2? All
persons subject to this final rule are considered to be in Tier 1unless they fallwithin Tier 2. The following table describes who is in Tier 1 andTier 2. 

### 22425

HeinOnline -- 69 Fed. Reg. 22425 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

TABLE 1.- PERSONS SUBJECT TO THE FINAL RULE: PERSONS IN TIER 1 AND TIER 

### 2

b. When isit appropriate foraperson requiredto complywith theruleto apply foran exemption ratherthanto submita letterofintentto conduct testing?You may apply for an exemption ifyou believe that the required testing will be performed by another person (or a consortium of
persons formed under TSCA section 4(b)(3)(A)). You can find procedures relating to exemptions in 40 CFR 790.80 through 790.99, and §799.5115(c)(2), (c)(5), (c)(7), and (c)(11) ofthe regulatory
text. In this final rule, EPA will not require the submission ofequivalence data (i.e., data demonstrating that your substance is equivalent to the substance actuallybeing tested) as a condition for approval ofyour exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 donot apply to this final test rule.

c. WhatwillhappenifIsubmitan exemptionapplication? EPAbelieves that requiring the collection of duplicative data isunnecessarily burdensome. As a result,ifEPAreceives

aletter ofintent to test from another

source or has received (or expects to receive) the test data that are required under this final rule, the Agency will conditionally approve your exemption application under 40 CFR 790.87. The Agency will terminate conditional exemptions ifa problem occurs with the initiation, conduct, or completion ofthe required testing, or with the submission ofthe required data to EPA. EPA may then require you to submit a letter of intent to test or an exemption application. See 40 CFR 790.93 and §799.5115(c)(10) ofthe regulatory text. Persons who obtain exemptions or receive them automatically will nonetheless be subject to providing reimbursement to persons who actually conduct the testing, as described in Unit V.E.4.

d. Whataremy obligationsifIam in Tier2?Ifyou are inTier 2, you are subject to the final rule and you are responsible for providing reimbursement to persons in Tier 1, as described in Unit V.E.4. You are considered to have an automatic conditional exemption. You do not need
to submit a letter ofintent to test or an exemption application unless you are notified by EPAthat you are required to do so.

Ifa problem occurs with the initiation, conduct, or completion ofthe required testing, orthe submission of the required datato EPA, the Agency may require you to submit a letter of intent to test or an exemption application. See 40 CFR 790.93 and §799.5115(c)(10) ofthe regulatory text. In addition, you will need to submit a letter ofintent to test or an exemption application if:

* No manufacturer in Tier 1has notified EPA ofits intent to conduct testing. * EPAhas published aFederal Register document directing persons in Tier 2to submit to EPA letters ofintent
to conduct testing or exemption applications. (See §799.5115(c)(4), (c)(5), (c)(6), and (c)(7) ofthe regulatory text.)
The Agency will conditionally approve

an exemption application under 40 CFR 790.87, ifEPA has received a letter of intent to test or has received (or expects to receive) the test data required under this final rule.

e. Subdivision ofTier2 entities.In the proposed rulethat preceded this final rule, EPA solicited comment onthe issue ofwhether the Agency should prioritize which persons in Tier 2 would be required to perform testing, if needed (Ref. 5,p. 31082). Specifically, the Agency suggested that it could subdivide Tier 2entities into:

* Tier2A. Tier 2manufacturers, i.e., those who manufacture, orintend to manufacture, atest rule substance solely

as one or more ofthe following: A byproduct; an impurity; a naturally occurring substance; a non-isolated intermediate; a component of aClass 2 substance; in amounts less than 1,100 lbs. annually; or in small quantities solely for research and development.

* Tier2B. Tier 2processors, i.e., those who process, or intend to process,

a test rule substance (in any form). The
terms "process" and "processor" are defined by TSCA section 3(10) and (11), respectively.

After consideration of comments received by the Agency (see Unit 111.1.3.), EPAhas decided that itwill subdivide Tier 2in the suggested
manner, and the final rule regulatory
text is structured to reflect this. Ifthe Agency needs testing frompersons in Tier 2,EPA will seek testing from
persons in Tier 2A before proceeding to Tier 2B. It is appropriate to require manufacturers in Tier 2A to submit letters ofintent to test or exemption applications before processors are called uponbecause the Agency believes that testing costs are traditionally passed by manufacturers along to processors, enabling them to share in the costs of testing (Ref. 74, p. 20654). In addition, "[t]here are [typically] so many processors [ofa given test rule chemical] that itwould be difficult to include them all in the technical decisions about the tests and in the financial decisions about howto allocate the costs" (Ref. 79, p. 31789).

f. HowdidEPA decidewho wouldbe in Tieri andTier2 andwho wouldbe excluded from the rule?Under 40 CFR 790.2, EPA may establish procedures applying to specific testrules that differ fromthe generic procedures governing TSCA section 4 test rules in 40 CFR part 790. Forthe purposes ofthis final rule, EPA is setting forth certain requirements Persons who manufacture (as defined at TSCA Tier 2A

section 3(7)), or intend to manufacture, a Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a test test rule substance who are not listed under rule substance solely as one or more of the following: Tier 2 -As a byproduct (as defined at 40 CFR 791.3(c)); -As an impurity (as defined at 40 CFR 790.3); -As a naturally occurring substance (as defined at 40 CFR 710.4(b)); -As a non-isolated intermediate (as defined at 40 CFR 704.3); -As a component of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i)); -In amounts of less than 500 kg (1,100 Ibs) annually (as described at 40 CFR

790.42(a)(4)); or -In small quantities solely for research and development (as described at 40 CFR

790.42(a)(5)) Tier 2B Persons who process (as defined at TSCA section 3(10)) or intend to process a test rule

substance (see 40 CFR 790.42(a)(2)) 

### 22426

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply)

HeinOnline -- 69 Fed. Reg. 22426 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

that differ from those under 40 CFR part 790.

In this test rule, EPAhas reconfigured the tiers in 40 CFR 790.42. EPA has added the following persons to Tier 2: Byproduct manufacturers; impurity manufacturers; manufacturers of naturally occurring substances; manufacturers ofnon-isolated intermediates; and manufacturers of components of Class 2 substances. The Agency took administrative burden and complexity into account in determining who was to be in Tier 1in this rule. EPA believes that those persons in Tier 1 who will conduct testing under this final rule will generally be large chemical manufacturers who, in the experience ofthe Agency, have traditionally conducted testing or participated in testing consortia under previous TSCA section 4(a) test rules.

The Agency alsobelieves that byproduct manufacturers, impurity manufacturers, manufacturers of naturally occurring substances, manufacturers ofnon-isolated intermediates, and manufacturers of components of Class 2 substances historically have not themselves participated in testing or contributed to the reimbursement ofthose persons who have conducted testing. EPA understands that these manufacturers
may include persons for whom the marginal transaction costs involved in negotiating and administering testing arrangements are deemed likely to raise the expense andburden oftesting to a level that is disproportionate to the additional benefits ofincluding these
persons in Tier 1.Therefore, EPA does
not believe that the likelihood ofthe persons who are being added to Tier2 actually conducting the testing is sufficiently high tojustify burdening these persons with Tier 1requirements (e.g., submitting requests for exemptions). Nevertheless, these persons, along with all other persons in Tier 2, are subject to reimbursement obligations to persons who actually conduct the testing, as described in Unit V.E.4.

TSCA section 4(b)(3)(B) requires all manufacturers andprocessors of a chemical substance to test that chemical substance ifEPAhas made findings for that chemical substance, and therefore issued a TSCA section 4(a) test rule requiring testing. However, practicality
must be a factor in determining who is subject to a particular test rule. Thus,
persons who donot know or cannot reasonably ascertain that they are manufacturing or processing the substances subject to this final rule, e.g., manufacturers orprocessors ofthe substances as trace contaminants who are not aware ofthese activities, are not subject to the final rule. (See Unit V.E.1. and §799.5115(b)(2) ofthe regulatory text.)

4. How do the reimbursement procedureswork? In the past, persons subject to test rules have independently worked out among themselves their respective financial contributions to those persons who have actually conducted the testing. However, if
persons are unable to agree privately on reimbursement, they may take advantage ofEPA's reimbursement procedures at 40 CFR part 791, promulgated under the authority of TSCA section 4(c). These procedures include:

* The opportunity for a hearing with the American Arbitration Association.
* Publication by EPA ofa Federal Register document concerning the request for a hearing.
* The appointment ofa hearing officer to propose an order for fair and equitable reimbursement.

The hearing officer may base his or her proposed order on the production volume formula set out at 40 CFR 791.48, but is not obligated to do so. Under this final rule, amounts manufactured as impurities will be included in production volume (40 CFR 791.48(b)), subject to the discretion of the hearing officer (40 CFR 791.40(a)). The hearing officer's proposed order
may become the Agency's final order, which isreviewable in Federal court (40 CFR 791.60).

F. WhataretheReportingRequirements UnderthisFinalRule?

A final report mustbe submitted for each chemical 13 months after the effective date ofthe final rule, i.e., by the deadline indicated in §799.5115(i) ofthe regulatory text. Although EPA originally proposed a deadline of9 months after the effective date, EPA extended the reporting deadline to 13 months after the effective date in
response to public comments. (See Unit III.E.2.f.). EPAis not requiring the submission ofinterim progress reports for the in vitrodermal absorption rate testing required in this final rule. For the short-term studies required bythis final rule, interim progress reports would likely yield little useful information. Furthermore, by not requiring interim progress reports for these short-term studies, the overall burden ofthe final rule will be somewhat reduced. G. What WouldINeedtoDo ifI Cannot Complete the Testing?

A company that submits a letter of intentto test under this final rule and that subsequently anticipates difficulties in completing the testing bythe deadline may submit a request to the Agency to modify the test schedule, pursuant to 40 CFR 790.55. EPA will determine whether modification ofthe
test schedule is appropriate, andmay first seek public comment on the modification.

H. Will Therebe Sufficient Test FacilitiesandPersonnelto Undertake the Testingin this TestRule?

Various surveys ofthe availability of test facilities and personnel to handle the additional demand for testing services created by TSCA section 4(a)
test rules indicate that available test facilities and personnel will adequately accommodate the testing specified in this final rule (Refs. 46, 52, and 53) (see also UnitIII.G.).

L MightEPA SeekFurther Testing ofthe Chemicalsin this Final Rule?
IfEPA determines that it needs additional dataregarding any ofthe chemical substances included in this final rule, the Agency might seek further health and/or environmental effects testing for these chemical substances. Should the Agency decide to seek such additional testing, EPA would initiate a separate action under TSCA section 4 for thatpurpose.
VI.Export Notification

Any person who exports, or who intends to export, one ofthe chemical substances contained in this final rule in any form is subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D. However, export notification is generally not required for articles, as providedby 40 CFR 707.60(b).

VII. Decision to Terminate Rulemaking

EPA is withdrawing the in vitro dermal absorption rate testingproposed

onJune 9, 1999 (64FR 31074) for 13 chemicals: Ethyl ether, isobutyl alcohol, sec-butyl alcohol, o-dichlorobenzene, pnitrotoluene, beta-chloroprene, n-amyl acetate, N-isopropylaniline, odinitrobenzene, ethyl bromide, ochlorotoluene, disulfiram, and NNdimethylaniline. The rationale for the decision to withdraw this proposed testing is presented in this unit.

A. EthylEther

DEPA commented that ethyl ether (CAS No. 60-29-7) should be removed fromthe rule, in part, because dermal 

### 22427

HeinOnline -- 69 Fed. Reg. 22427 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

absorption rate data had previously been developed and because the high volatility ofethyl ether would not allow

a dermal absorption rate tobe adequately determined under the proposed standard (Ref. 21).

EPA and OSHA have reviewed the dermal absorption rate study byBlank et al., 1967 (JournalofInvestigative Dermatology.49:582-589), submitted by DEPA as an attachment to its comments (Ref.21). The study measured a Kp for

an aqueous solution ofethyl ether through a human abdominal epidermal membrane using an in vitrostatic diffusion cell. Barrier function was maintained as verified by measuring penetration oftritiated water. Most other experimental parameters conformed with the standard proposed by EPA for determining an in vitro dermal absorption rate. A sensitive gas chromatographic method was used to analyze the receptor fluid in place of radiolabeled compound. Itis unclear whether absorption was determined under occluded or unoccluded conditions, but the Kp values are close
to theoretical calculations, indicating that ethyl ether evaporation likely did
not confound absorption measurements under these experimental conditions. Skin penetration ofthe neat liquid was not reported, but EPA and OSHA believe this canbe estimated using the
aqueous Kp value and data on water solubility and liquid density. Therefore, EPA and OSHA believe that this study provides sufficient data for an adequate determination ofthe dermal absorption
rate information sought in this rulemaking and testing ofethyl ether is
not required at this time (Ref.62).

B. IsobutylAlcohol andSec-Butyl Alcohol

ACC, in its comment proposing a category approach when testing chemical substances to determine in vitrodermal absorption rates, noted that in its suggested aliphatic alcohol category, three ofthe four possible isomers for butyl alcohol were included in the proposed rule (Ref. 15). ACC stated that given their same molecular weight and functionality, and taking into consideration the likelihood of there being existing dermal absorption
rate data for other three-, four-, and fivecarbon alcohols, evaluating the three isomers using a structure activity relationship (SAR) approach would
appear reasonable, in lieu oftesting three chemicals under this rule.

The three butyl alcohols referred to by ACC are isobutyl alcohol (CAS No. 78- 83-1), sec-butyl alcohol (CASNo. 78- 92-2), and tert-butyl alcohol (CASNo. 75-65-0). The first two were included in the proposed rule. The third substance, tert-butyl alcohol was cited in the proposed rule (Ref. 5) as a chemical substance that was removed from the test list as aresult of a 1998 study.The fourth butyl alcohol, not included in the proposed test rule, isnbutyl alcohol (CASNo. 71-36-3) which the ITC found to have sufficient dermal absorption rate data.

EPA agrees with ACC that sufficient data on in vitro dermal absorption rates have been generated on three, four, and five carbon aliphatic alcohols to adequately predict Kps for isobutyl alcohol and sec-butyl alcohol (Ref.62). In vitrodermal absorption rates and Kps using human skin have already been measured for a series ofhomologous
two [ethanol], three [propanol], four [nbutanol], and five [pentanol] carbon aliphatic alcohols (Ref.65). This provides adequate structure activity information topredict the dermal absorption rates for the closely related branched chain alcohols, isobutyl alcohol and sec-butyl alcohol, with reasonable accuracy. Therefore, EPA is
not requiring the testing ofisobutyl alcohol and sec-butyl alcohol under this final rule.

C. o-Dichlorobenzene

The Chlorobenzene Producers Association citedtwo documents to support its position that testing ofodichlorobenzene (CAS No. 95-50-1) is unnecessary (Ref. 31). The Association cited EPA's DermalExposure Assessment:Principles and Applications (Ref.42), which described

a calculated Kp for o-dichlorobenzene. The Association also noted thata study conducted atthe North Carolina State University atRaleigh entitled Percutaneous AbsorptionofVolatile Compounds (Ref.50) analyzed the relative absorption andpenetration ofodichlorobenzene on the skin surface in the context of evaluating volatile organic compounds.

The Kp value for o-dichlorobenzene cited in the 1992 EPA Report on dermal
exposure assessment is estimated from empirical models rather than experimental data and, therefore, does
not meet OSHA needs. However, the data developed for o-dichlorobenzene in the context of evaluating percutaneous absorption ofvolatile organic compounds does provide ameasure of the dermal absorption rate ofodichlorobenzene. Therefore, testing ofodichlorobenzene is not required in this final rule.

D.p-Nitrotoluene

First Chemical Corporation provided EPA with biological monitoring information (Ref. 17a.), toxicity studies (Ref. 17b.), and specific information on the numbers ofworkers exposed topnitrotoluene (CASNo. 99-99-0) (Ref. 17). First Chemical Corporation concluded from the submitted information thatp-nitrotoluene does not present a significant hazard from dermal
contact and proposed that this chemical be removed from the test list. One study (Ref. 17a.) discussed biological monitoring in workers but did not

measure dermal absorption. An acute toxicity study with short-term dermal administration to experimental animals

was negative (Ref. 17b.). This study also did not attempt to measure dermal absorption, and, therefore is not adequate to eliminate the testing requirement. A submission under section 8(d) ofTSCA "found no evidence of skin absorption when a dermal dose of1.0 g/kg was applied to rabbits" (Ref.17) but further review by EPA finds nomention ofthe methodology or data that support this
statement in the submission. EPA does
not consider the data cited byFirst Chemical Corporation tobe sufficient to determine a dermal absorption rate for p-nitrotoluene (Ref.62).

First Chemical Corporation also submitted datarelevant to EPA's finding ofsubstantial human exposure. First Chemical Corporation is the only domestic manufacturer ofp-nitrotoluene and accounts for the vast majority ofthe total quantity onthe U.S. market. The
company provided information on handling procedures, onsite operations, and a summary ofthe number of workers with potential exposure to the chemical. This summary was based on

a survey ofonsite operations and inquiries to each offsite company known to handle p-nitrotoluene. EPA has reviewed these data and agrees with First Chemical Corporation that the number ofworkers exposed to pnitrotoluene at its facilities andthose of its customers (processors) do notmeet the general worker threshold for substantial human exposure that EPA has established to require testing under TSCA section 4(a)(1)(B). EPAhas also reviewed the information submitted in
response to the TSCA section 8(a)PAIR forp-nitrotoluene (Ref.8). PAIR information for 1994revealed that another company in the p-nitrotoluene market did not use p-nitrotoluene in its
processes, sell itto its customers, or report any worker exposure, thus makingthe number ofexposed workers reported by FirstChemical Corp. the total ofthe reported worker exposures in the United States. Therefore, EPA is 

### 22428

HeinOnline -- 69 Fed. Reg. 22428 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

not requiring testing ofp-nitrotoluene under this final rule.

E.beta-Chloroprene

DuPont DowElastomers (DDE) provided EPA with specific information

onproduction and worker exposure to beta-chloroprene (CASNo. 126-99-8) duringproduction and use (Ref.24). According to DDE, domestic production ofbeta-chloroprene occurs only at DDE's facility in LaPlace, Louisiana. DDE also states that no beta-chloroprene is imported. DDE acknowledges that beta-chloroprene is manufactured in quantities in excess ofone million pounds per year which satisfies the "substantial production" TSCA section 4(a)(1)(B) finding. However, the company maintains that the number of workers exposed to beta-chloroprene does not meet the general "substantial human exposure" TSCA section 4(a)(1)(B) finding.

According to DDE, more than 90% of beta-chloroprene produced annually is used for the production of dry polychloroprene. Most ofthe remaining beta-choloroprene is used to produce polychloroprene latex, a colloidal suspension ofpolychloroprene in water. A small portion is used to manufacture

a comonomer, subsequently incorporated in polychloroprene polymerization. DDE states thatpolymer manufacture is the only commercial use ofbeta-chloroprene. From its sole betachloroprene production facility in Louisiana, DDE produces betachloroprene monomer to supply its polychloroprene manufacturing operations. DDE, the only domestic producer ofbeta-chloroprene or polychloroprene, handles betachloroprene at only two ofits facilities and the total number ofDDE employees
atthese sites is approximately 500. DDE
states that the actual number ofthe workers exposed via the dermal route is significantly less than the total number ofDDE employees at the two facilities that manufacture orhandle betachloroprene. DDE has determined that the total number ofworkers potentially exposed to beta-chloroprene vapor is less than 200. Due to the nature ofthe beta-chloroprene andpolychloroprene manufacturing processes, the number of workers with potential exposure to liquid beta-chloroprene is apparently significantly less than those potentially exposed to beta-chloroprene vapor.

EPA has reviewed the production and worker exposure information submitted by DDE and concurs with DDE in its
assessment ofthe potential number of workers exposed to beta-chloroprene. Because the potential number of workers exposed to beta-chloroprene does not appear to meet the threshold that EPA generally relies upon in making the TSCA section 4(a)(1)(B) "substantial human exposure" finding

onthe basis ofworker exposure, testing ofbeta-chloroprene is not required under this final rule.

F. n-Amy] acetate

EPA and OSHA have reviewed a dermal absorption study for n-amyl
acetate (CASNo. 628-63-7) submitted by Union Carbide Corporation (Ref.47). A Kp and 6-24 hours dermal absorption
rates for n-amyl acetate were determined. Absorption data were also collected at earlier time points of 10 minutes and 1hour. The method used

an in vitrostatic diffusion cell technique with human cadaver skin and was similar,but not identical, to the test standard for the study required in this final rule. The test substance was a mixed isomer ofprimary amyl acetate applied neat (65% n-amyl acetate) rather than as apure compound. A sensitive (non-radiolabeled) gas chromatographic technique specific to n-amyl acetate was used as a detection method. The anatomical region ofthe skin andmembrane thickness were not stated, although variability in the results and the method ofepidermal membrane preparation were found to be acceptable. The receptor fluid was ethanol in water instead ofthe PEG solution required in the test standard for this final rule; however, itis unlikely that this influenced the results ofthe study because ethanol in water, as statedpreviously in Unit III.E.2.o.vii., is generally a suitable receptor fluid. This is the case despite the fact thatunder this final rule EPA is requiring the use ofa PEG solution as the receptor fluid for allhydrophobic chemicals for
purposes ofconsistency. Therefore, EPA and OSHAbelieve that this study provides sufficient data for an adequate determination ofdermal absorption rate and further testing ofn-amyl acetate is
not required under this final rule (Ref. 64).

G. N-Isopropylaniline

Monsanto Company provided EPA with specific information on production and worker exposure toNisopropylaniline (CASNo. 768-52-5) duringproduction and use (Ref. 16). Monsanto Company stated thatNisopropylaniline is an intermediate in the production ofthe pesticide propachlor, the active ingredient in Ramrod branded herbicides, and is produced and consumed atthe Monsanto plant in Muscatine, Iowa. No N-isopropylaniline is sold or used domestically for any otherpurpose. Propachlor, which was introduced on the market in 1965, is nearing the end ofits commercial life cycle and production ofN-isopropylaniline has fallen accordingly. Thus, itis anticipated that N-isopropylaniline will be produced in amounts far less than the Agency's general "substantial production" threshold of one million pounds per year.

Monsanto Company also provided EPA with a detailed description ofthe number ofworkers exposed to Nisopropylaniline during production and

use. N-isopropylaniline is produced and consumed in enclosed systems. Monsanto Company projected a maximum of 35 workers are potentially exposed to N-isopropylaniline.

EPA has reviewed the production and worker exposure information submitted by Monsanto Company forNisopropylaniline. EPAhas confirmed, via 1998 and 2002 IUR data (see 40 CFR part 710), that manufacture (including import)ofN-isopropylaniline is below the one million pounds per year threshold which EPA generally relies upon as "substantial production" under TSCA section 4(a)(1)(B). In addition, the potential number ofworkers exposed to N-isopropylaniline does not appear to meet the "substantial human exposure" threshold ofexposure equal to orgreater than 1,000 workers which EPA generally relies upon in making the TSCA section 4(a)(1)(B) "substantial human exposure" finding on the basis ofworker exposure. As aresult, testing ofN-isopropylaniline is not required underthis final rule.

H. o-Dinitrobenzene

EPA received no comments in response to its proposal torequire that o-dinitrobenzene (CAS No. 528-29-0) be testedto determine an in vitro dermal absorption rate. In developing a finding for the final rule of"substantial production" under TSCA section 4(a)(1)(B) for this chemical, EPA found that according to 1998 IUR data (see 40 CFR part 710), o-dinitrobenzene is no longer produced or imported in
amounts equal to or greater than one millionpounds per year.The 1998 IUR databecame available afterthe publication ofthe proposed rule, which made a finding for substantial production based on 1994 IURdata. Also, there were no 2002 IUR data reported for o-dinitrobenzene. Because the 1998 IURdata and the lack of 2002 IURdata do not support afinding of substantial production as required underTSCA section 4(a)(1)(B)(i), testing ofo-dinitrobenzene to determine an in vitroabsorption rate is not required at this time. 

### 22429

HeinOnline -- 69 Fed. Reg. 22429 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

L EthylBromide,o-Chlorotoluene, Disulfiram,andNN-Dimethylaniline

In developing findings for the final rule of"substantial production" under TSCA section 4(a)(1)(B) for ethyl bromide (CAS. No. 74-96-4), ochlorotoluene (CASNo. 95-49-8), disulfiram (CAS No. 97-77-8), and NNdimethylaniline (CASNo. 121-69-7), EPA found thataccording to 2002 IUR data (see 40 CFR part 710), these four chemical substances are no longer manufactured orimported in amounts equal to or greater than one million pounds per year. Because the 2002 IUR data show manufacture (including import)below the one million pounds
per year threshold which EPA generally relies upon as "substantial production" under TSCA section 4(a)(1)(B)(i), testing ofethyl bromide, o-chlorotoluene, disulfiram, and NN-dimethylaniline to determine in vitrodermal absorption
rates is not required at this time.

VIII. Economic Impacts

EPA has prepared an economic
assessment entitled EconomicImpact Analysis andSmallEntityImpact Analysis ofthe TSCA Section4(a) Test Rulefor34 ChemicalsTargeted forIn Vitro Dermal AbsorptionRate Testing (Ref.57), a copy ofwhich has been placed in the official public docket. This economic assessment evaluates the potential for significant economic impacts as a result ofthe testing that would be required by this final rule. The total cost ofproviding test data on the 34 chemicals that were evaluated in this economic analysis is estimated tobe a total of $1.16 million for all 34 chemicals, or $33,987 per chemical (Ref. 57).

While legally subject to this test rule, Tier 2manufacturers and all processors ofa subject chemical would only be required to comply with the requirements ofthe final rule ifthey are directed to do so by EPA as described in §799.5115(c)(5), (c)(7) and (c)(10) of the regulatory text. EPA would require Tier 2manufacturers or processors to test only ifno Tier 1manufacturer has submitted aletter ofits intent to conduct testing, or if,under 40 CFR 790.93, a problem occurs with the initiation, conduct, or completion ofthe required testing, or the submission of the required data to EPA. Because EPA has identified at least one manufacturer in Tier 1for each subject chemical, the Agency expects that, for each chemical in this final rule, at least one such
person will submit a letter ofintent to conduct the required testing and that person will conduct such testing and will submitthe test data to EPA. EPA believes, therefore, that there will notbe any costs to Tier 2manufacturers or processors for conducting the testing required bythe final rule. In addition,

as explained in Unit III.J., EPAis not

aware ofany circumstances in which Tier 1 entities have sought reimbursement fromTier 2entities either through private agreements orby soliciting the involvement ofthe Agency under the reimbursement regulations at 40 CFR part 791. Given this consistent experience with previous test rules, EPA does not believe that there will be any administrative, negotiation, or any other
costs associated with seeking reimbursement fromTier 2companies.

To evaluate the potential for an adverse economic impact oftesting on manufacturers ofthe chemical substances in this final rule, EPA employed a screening approach that
compares the annual revenues from the sale of achemical to the annualized testing costs for that chemical and
expresses the testing costs as a percent ofrevenues generated from each chemical. Annualized testing costs divide testing expenditures into an equivalent, constant yearly expenditure

over a longer period oftime. To calculate the percent price impact, testing costs (including laboratory and administrative expenditures) are annualized over 15 years using a 7% discount rate. Annualized testing costs

are then divided bythe estimated annual revenue ofthe chemical to derive the cost-to-sales ratio.

EPA estimates the annualized cost of testing the 34 chemicals evaluated in the economic analysis to be $3,732 per chemical or atotal annualized cost of $126,888 for all 34 chemicals (34 x $3,732) (Ref.57). In addition, the TSCA section 12(b) export notification that is required for the first export to a particular country of a chemical subject
to the final rule, is estimated to be $61.31 for the first time that an exporter must comply with TSCA section 12(b) export notification requirements, and $18.07 for each subsequent export notification submitted by an exporter (Ref.57). The Agency's estimated total
costs oftesting (includingboth laboratory and administrative costs), annualized testing costs, price impacts, andpublic reporting burden hours for this final rule are presented in the economic impact analysis (Ref. 57).

Price data were available for 26 ofthe 34 chemicals, with an average cost of $.88 per pound for those 26 chemicals. The price impact ofthe test costs is a function ofthe chemical's price per pound and the production volume. For 21 ofthe 26 chemicals (80.8%) for which price data were available, the price impact is less than 1.0% when the production volume for each chemical is assumed tobe one million pounds, which is the threshold for substantial production. The average test cost impact for all 26 chemicals withprice data was 0.68%. This means that the testing costs represent, on average, 0.68% of

revenues generated from each chemical. The actual impacts are likely to be lower, however, because all ofthe subject chemicals are produced in volumes of atleast one million pounds
peryear. With a price impact ofless than 1.0%, EPA concludes that for these 21 chemicals the potential for adverse economic impacts is low.

For five ofthe twenty-six chemicals (19.2%) with price data, the price impact is in excess of 1.0%. The average price impact for these five chemicals is 1.96% and the maximum is 3.7%. Again, these impacts occur when the production volumes are assumed to be

one million pounds. The actual impacts decline in direct proportion to a chemical's actual production volume above one millionpounds. Thus, ifthe actual production volume is two million pounds, the impact is reduced by 50%. The Agency verified production volumes for these five chemicals based

on the 2002 reports to the TSCA Chemical Update System Database, and has found that the actual production volume in each case exceeds 10 million pounds per year. Therefore, the Agency believes that the impact for allfive of these chemicals is below 1.0%.

The Agency computed "critical prices" for the remaining eight chemicals forwhich price data were not available. The "critical price" isthe price per pound below which there wouldbe an impact of 1.0% orgreater. Assuming aminimum production volume of one million pounds peryear and annualized testing costs of $3,732
per chemical, the critical price is $0.37
perpound. Below thatprice, the testing
costs wouldrepresent more than 1.0% ofthe revenues from the chemical at a

one million pound production volume level. The average price for the 26 chemicals with actual price data available is $0.88 perpound. Thus,the critical price is substantially below this
average. While it cannot be shown conclusively that the price impacts will be less than or greater than 1.0% ofthe sales for these chemicals, the Agency believes that adverse impacts are unlikely, given thatboth the chemicals' prices would have to be below $.37 per pound, and the production volume would have to meet the worst-case assumption of one million pounds per year. 22430

HeinOnline -- 69 Fed. Reg. 22430 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

On the basis ofthese calculations, EPA believes that the required chemical testing presents alow potential for adverse economic impact for the majority ofthe chemicals subject to the final rule. Because the subject chemical substances have relatively large production volumes, the annualized
costs oftesting, expressed as a percentage of annual revenues, are very small for most chemicals. There are, however, eight chemicals for which it
cannot conclusively be shown that the price impact will bebelow 1.0% ofthe

revenue for these chemicals. For these eightchemicals, companies may choose
to use revenue sources other than profits from the individual chemicals to pay for testing. To account for this, the Agency also compared the costs of compliance
to company sales data. These calculations were made as part ofthe Agency's small entity impact analysis (Ref.57), conducted in accordance with the requirements ofthe Regulatory Flexibility Act, as amended bythe Small Business Regulatory Enforcement Fairness Act. These results are presented in Unit X.B.

IX. Materials in the Docket

An official docket was established under docket ID number OPPT-2003- 0006. The official public docket includes information considered by EPA in developing this final rule, such as the documents specifically referenced in this action, any public comments received, and other information related
to this action. In addition, interested parties should consult documents that

are referenced in the documents that EPA has placed in the docket, regardless ofwhether these referenced documents

are physically located in the docket. For assistance in locating documents that

are referenced in documents that EPA has placed in the docket, but that are not physically located in the docket, please consult one ofthe technical
persons listed under FOR FURTHER INFORMATION CONTACT. The official public docket is available for review as specified in ADDRESSES. The following is a listing ofthe documents referenced in this preamble that have been placed in the official docket for this final rule:

A. Supporting Documentation
1.U.S. Census Bureau. Bridge between NAICS and SIC. 1997 Economic Census. Core Business Statistics Series. Issued June 2000.

2.United States Environmental Protection Agency (USEPA). Laboratory Cost Estimate for In VitroDermal Absorption Rate Testing-Short-term Absorption Rate. Prepared by Economic and Policy Analysis Branch (EPAB), Economics, Exposure andTechnology Division (EETD), OPPT. February 20, 2003.

3.USEPA. Laboratory Cost Estimate for In Vitro Dermal Absorption Rate Testing-Long-term Absorption Rate. Prepared byEPAB, EETD, OPPT. March 26, 2003.

4. Background information listed in §799.5115(h)(8) ofthe regulatory text:

a. Bronaugh, R.L., Stewart, R.F., and Simon, M. Methods for in vitro Percutaneous Absorption Studies VII: Use ofExcised Human Skin. Journalof Pharmaceutical Sciences. 75:1094- 1097. 1986.

b. Bronaugh, R.L. and Stewart, R.F. Methods for in vitroPercutaneous Absorption Studies IV: The FlowThrough Diffusion Cell. Journalof Pharmaceutical Sciences. 74:64-67. 1985.

c. Bronaugh, R.L., Stewart, R.F., and Storm,J.E. Extent ofCutaneous Metabolism During Percutaneous Absorption ofXenobiotics. Toxicology andAppliedPharmacology. 99:534- 543. 1989.

d. Walker, J.D., Whittaker, C. and McDougal, J.N. Role ofthe TSCA Interagency Testing Committee in Meeting the U.S. Government Data Needs: Designating Chemicals for Percutaneous Absorption Rate Testing. Dermatotoxicology.F. Marzulli and H. Maibach, Eds. Taylor &Francis, Washington, DC. pp. 371-381. 1996.

e. Bronaugh, R.L., and Collier, S.W. Protocol for In Vitro Percutaneous Absorption Studies. In Vitro Percutaneous Absorption:Principles, Fundamentals, andApplications.R.L. Bronaugh and H.I. Maibach, Eds. CRC Press, Boca Raton, FL. pp. 237-241. 1991.

B. References
1.Interagency Testing Committee (ITC). Thirty-First Report ofthe TSCA Interagency Testing Committee to the Administrator; Receipt ofReport, Request forComments, Opportunity to Initiate Negotiations for TSCA Section 4 Testing Consent Agreements. Federal Register (58 FR 26898, May 5, 1993) (FRL-4583-4).

2.ITC. Thirty-Second Report ofthe TSCA Interagency Testing Committee to the Administrator; Receipt ofReport, Request forComments, Notice of Opportunity to Initiate Negotiations for TSCA section4 Testing Consent Agreements. Federal Register (58 FR 38490, July 16, 1993) (FRL-4630-2).

3.ITC. Thirty-Fourth Report ofthe TSCA Interagency Testing Committee to the Administrator; Receipt ofReport and Request for Comments. Federal Register (59FR 35720, July 13, 1994) (FRL-4870-4).

4. ITC. Thirty-Fifth Report ofthe TSCAInteragency Testing Committee to the Administrator; Receipt ofReport, Request for Comments, Solicitation of Interested Parties in Developing Testing Consent Agreement. Federal Register (59 FR 67596, December 29, 1994) (FRL-4923-2).

5. USEPA. Proposed Test Rule for In VitroDermal Absorption Rate Testing of Certain Chemicals ofInterest to Occupational Safety and Health Administration. Federal Register (64FR 31074, June 9, 1999) (FRL-5760-3).

6. USEPA. Preliminary Assessment Information and Health and Safety Data Reporting; Addition of Chemicals. (TSCA Sections 8(a) and 8(d) Final Rules for Chemicals contained in the ITC's 31st Report to the EPA Administrator). Federal Register (58FR 68311, December 27, 1993) (FRL-4644- 1).7. USEPA. Preliminary Assessment Information and Health and Safety Data Reporting; Addition of Chemicals. (TSCA sections 8(a) and 8(d)Final Rules for Chemicals contained inthe ITC's

32nd Reportto the EPA Administrator). Federal Register (59 FR 5956, February 9, 1994) (FRL-4745-5).

8. USEPA. Preliminary Assessment Information and Health and Safety Data Reporting; Addition of Chemicals. (TSCA Sections 8(a) and 8(d) Final Rules for Chemicals contained in the ITC's 3 5 th Report to the EPA Administrator). Federal Register (60FR 34879, July 5, 1995) (FRL-4954-9).

9. USEPA. Thirty-Sixth Report ofthe TSCAInteragency Testing Committee to the Administrator; Receipt ofReport, Request for Comments, Solicitation of Use and Exposure Data. Federal Register (60FR 42982, August 17, 1995) (FRL-4965-6).

10. USEPA. Request for Proposals for Enforceable Consent Agreements; Dermal Absorption Rate Testing of Eighty OSHA Chemicals; Solicitation of Interested Parties; Text ofTest Protocol. Federal Register (61 FR 14773, April 3, 1996) (FRL-5359-3).

11. ARCO Chemical Company. Proposal to conduct in vivo dermal absorption rate testing for tert-butyl alcohol under an enforceable consent agreement (ECA). Letter from Joan McCuen to Charles M. Auer, OPPT, USEPA. June 26, 1996.

12. ARCO Chemical Company. A letter fromJoan McCuen to Keith Cronin, OPPT, USEPA transmitting a dermal absorption rate study (Ref. 12a.). March 23, 1998.

12a. Huntington Life Sciences Ltd., Suffolk, England. [14C]-t-Butyl Alcohol: 

### 22431

HeinOnline -- 69 Fed. Reg. 22431 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

Topical Application: Dermal Absorption Study in the Male Rat; Final Report. Prepared for ARCO Chemical Company. January 7, 1998. 13. Bronaugh, R.L. and Collier, S.W. Protocol for in vitro Percutaneous Absorption Studies. In Vitro Percutaneous Absorption:Principles, Fundamentals, andApplications.R.L. Bronaugh and H.I. Maibach, Eds. CRC Press, Boca Raton, FL. Chapter 19, pp. 237-241. 1991.

14. Chemical Manufacturers Association (CMA). Comments on ITC proposal for dermal penetration testing andprotocol (Ref. 14a.) proposed by CMA. Letter from Sarah Doelp to Charles M. Auer, USEPA. October 21, 1994.

14a. CMA, Existing Chemicals Testing Task Group. Proposed Protocol for In Vitro Percutaneous Absorption Studies. October 4, 1994.

15. ACC. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 10, 1999. 16. Monsanto Company. Comments

onEPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. July 19, 1999.

17. First Chemical Company. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 4, 1999.

17a. Linch, A.L. Biological monitoring for industrial exposure to cyanogenic aromatic nitro and amino compounds. AmericanIndustrialHygiene AssociationJournal.35:426-432. 1974. 17b. Kinkead, E.R., MacEwen, J.D., Haun, C.C., Vernot, E.H., and Dacre, J.C. Toxic hazards evaluation offive atmospheric pollutants from Army ammunition plants. Prepared by University of California, Irvine for Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, OH. Report number AMRL-TR-77-25. June 1977.

18. American Forest &Paper Association. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999. 19. American Petroleum Institute. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

20. Biphenyl Work Group, Washington, DC. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals of Interest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 6, 1999.

21. Diethyl Ether Producers Association, Inc. Comments onEPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals of Interest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

22. Synthetic Organic Chemical Manufacturers Association, Inc. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

23. Acetonitrile Task Force. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

24. DuPont DowElastomers. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

25. Fragranced Products Information Network. Comments onEPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. July 6, 1999. 26. Association ofVeterinarians for Animal Rights. Comments onEPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals of Interest to OSHA submitted to the TSCA Public Docket Office, USEPA. July 17, 1999.

27. People for the Ethical Treatment ofAnimals. Comments onEPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. July 30, 1999. 28. Animal Protection Institute, Midwest Regional Office. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 4, 1999.

29. Humane Society ofthe United States. Comments onEPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

30. Doris Day Animal League. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

31. Chlorobenzene Producers Association. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

32. Tetrahydrofuran Task Force. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

33. Private Citizen. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. June 15, 1999.

34. ACC Naphthalene Panel. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

35. ACC Propylene Glycol Ethers Panel. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 6, 1999.

36. ACC Olefins Panel. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing ofCertain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

37. ACC Hydrocarbon Solvents Panel. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

38. ACC Ketones Panel and Oxo Process Panel. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In VitroDermal Absorption 

### 22432

HeinOnline -- 69 Fed. Reg. 22432 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

Rate Testing ofCertain Chemicals of Interest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

39. ACC Carbon Disulfide Panel. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals ofInterest to OSHA submitted to the TSCA Public Docket Office, USEPA. August 9, 1999.

40. Buell, D.A., Blaustein, M.B., and Lynch, J.R. An Assessment ofthe National Occupational Exposure Survey. Prepared byTemple, Barker & Sloane, Inc. and Exxon Corp. Undated.

41. Seta,J.A., Sundin, D.S., and Pedersen, D.H. NationalOccupational ExposureSurveyFieldGuidelines. National Institute for Occupational Safety and Health, Cincinnati, OH. DHHS (NIOSH) Publication No. 88-106. 1988.

42. USEPA, Office ofResearch and Development. DermalExposure Assessment:Principles and Applications.EPA/600/8-91/011B. January 1992.

43. USEPA. Voluntary Children's Chemical Evaluation Program. Federal Register (65 FR 81699, December 26, 2000) (FRL-6758-5).

44. OECD, Paris. Guidance Document for the Conduct ofIn VitroSkin Absorption Studies. (Draft). April 1999.

45. Harrison, S.M., Barry, B.W., and Dugard, P.H. Effects offreezing on human skin permeability. Journal of PharmacyandPharmacology.36: 261. 1984.

46. USEPA. Laboratory Capacity and the HPV Challenge Program. OPPT/ EETD/EPAB, Washington, DC. October 14, 1999.

47. Union Carbide Corporation (now Dow Corporation). A letter from Dr. Imogene Treble to Frank Kover, USEPA transmitting a study entitled Primary Amy] Acetate,MixedIsomers:In Vitro Percutaneous Absorption Studyin Human Skin. July 5, 2000.

48. USEPA. Proposed Test Rule for Hazardous Air Pollutants. Federal Register (61 FR 33178, June 26, 1996) (FRL-4869-1).

49. National Institute for Occupational Safety andHealth. National Occupational Exposure Survey. March 29, 1989.

50. Riviere, J.E., Brooks, J.D., Qiao, G.L., and Monteiro-Riviere, N.A. Percutaneous Absorption ofVolatile Chemicals.Prepared byNorth Carolina State University, Raleigh, NC for AFSOR/NL, Bolling AFB, Washington, DC. NTIS number ADA332910. November 1997. 51. USEPA. Data Collection and Development on High Production Volume (HPV)Chemicals. Federal Register (65 FR 81686, December 26, 2000) (FRL-6754-6).

52. USEPA. EPA Census ofTSCA Testing Laboratories. Prepared by OPPT, EETD, EPAB, Washington, DC. October 10, 1996.

53. USEPA. Analysis ofU.S. Laboratory Capacity for Developmental and Reproductive Toxicity Testing and the Impact ofExpanded TSCA Test Rules. Prepared by OPPT/EETD/EPAB, Washington, DC. May 28, 1999. 54. USEPA. ChemRTK, HPV Challenge Program Chemical List. Prepared by OPPT. (Thislist isupdated periodically, andis available electronically athttp://www.epa.govchemrtk/hpvchmlt.htm)

55. USEPA. TSCA section 4(a)(1)(B) Final Statement ofPolicy.Federal Register (58 FR 28736, May 14, 1993) (FRL-4059-9).

56. USEPA. Information on OSHA Dermal Test Rule Chemicals: TRI Release Data and Number ofWorkers Exposed. Prepared by OPPT/EETD/ Chemical Engineering Branch (CEB), Washington, DC. April 24, 2001 and March 1998. 57. USEPA. Economic Impact Analysis and Small Entity Impact Analysis ofthe TSCA Section 4(a) Test Rule for 34 Chemicals Targeted for In Vitro Dermal Absorption Rate Testing. Prepared by OPPT/EETD/EPAB, Washington, DC. February 3, 2004. 58. USEPA. Guidelines for Exposure Assessment. Federal Register (57 FR 22888, May 29, 1992) (FRL-4129-5).

59. Small Business Administration, Office of Size Standards. Small Business Size Standards matched to North American Industry Classification System (NAICS). Onwebsite: http:// www.sba.gov/size/sizetable2002.html.

60. USEPA. Treatment of 12(b) Export Notification Unit Costs for section 4 Test Rule Analyses. Prepared byLynne Blake-Hedges OPPT/EETD/EPAB, Washington, DC. April 1, 1999. 61. USEPA. Economic Analysis in Support ofthe TSCA 12(b) Information Collection Request. Prepared by Joseph Callahan OPPT/EETD/EPAB, Washington, DC. October 30, 1998. 62. OSHA. OSHA dermal test rule. Electronic mail from Val Schaeffer to Keith Cronin, USEPA. May 22, 2000. 63. OSHA. Dermal rule. Electronic mail from Val Schaeffer to Keith Cronin, USEPA. March 20, 2002. 64. OSHA. Dermal rule. Electronic mail from Val Schaeffer to Keith Cronin, USEPA. August 25, 2000. 65. Scheuplein, R.J. and Blank, I.H. Mechanism ofpercutaneous absorption. IV. Penetration ofnonelectrolytes (alcohols)from aqueous solutions and frompure liquids.Journalof InvestigativeDermatology.60:286-296. 1973.

66. USEPA. Wage Rates forEconomic Analysis ofthe Toxics Release Inventory Program. Prepared by Cody Rice, Analytical Support Branch, Environmental Analysis Division, Office ofEnvironmental Information. April 11, 2002.

67. USEPA. Review of comments received on proposed dermal absorption
test rule. Memorandum from Greg Macek, CEB to Keith Cronin, Chemical Control Division. October 8, 1999.

68. USEPA. Office ofWater Chemicals; Final Test Rule.Federal Register (58FR 59667, November 10, 1993) (FRL-4047-2).

69. USEPA. Testing Consent Agreements and Test Rules; Final Rule.Federal Register (55 FR 18881, May 7, 1990) (FRL-3687-6).

70. USEPA. Amended Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period. Federal Register (62FR 67465, December 24, 1997) (FRL-5742-2).

71. USEPA. Inventory Reporting Requirements; Final Rule. Federal Register (42FR 64571, December 23, 1977) (FRL-817-1).

72. USEPA. Office ofSolid Waste Chemicals; Final Test Rule.Federal Register (53 FR 22300, June 15, 1988) (FRL-3396-8).

73. USEPA. Amended Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period. Federal Register (63FR 19694, April 21, 1998) (FRL-5780-6).

74. USEPA. Toxic Substances; Test Rule Development and Exemption Procedures. Federal Register (50 FR 20652, May 17, 1985) (FRL-2809-7).

75. USEPA. Methylcyclopentane and Commercial Hexane; Proposed Test Rule. Federal Register (51 FR 17854, May 15, 1986) (FRL-3008-8).

76. USEPA. Commercial Hexane and Methylcyclopentane; Final Test Rule. Federal Register (53 FR 3382, February 5, 1988) (FRL-3325-1).

77. USEPA. Toxic Substances; Biphenyl; Final TestRule.Federal Register (50FR 37182, September 12, 1985) (FRL-2871-5).

78. USEPA. Office ofWater Chemicals, Final Test Rule; Clarification. Federal Register (59FR 45629, September 2, 1994) (FRL-4047- 2).79. USEPA. Toxic Substances Control Act; Data Reimbursement.Federal Register (48FR 31785 July 11, 1983) (FRL-2349-8). 

### 22433

HeinOnline -- 69 Fed. Reg. 22433 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

X. Statutoryand Executive Order Reviews

A. Paperwork ReductionAct
The information collection requirements contained in TSCA section 4 test rules have already been approved by OMB under the provisions ofthe Paperwork Reduction Act, 44 U.S.C. 3501 etseq., and havebeen assigned OMB control number 2070-0033 (EPA ICR No. 1139). The information collection activities related to export notification under TSCA section 12(b)(1) are already approved under OMB control number 2070-0030 (EPA ICR No. 0795). This final rule does not contain any new or amended requirements that would require additional review and/or approval by OMB.

The standard chemical testing program involves the submission of letters ofintent to test (or exemption applications), study plans, progress reports, and test results. EPA estimates that the information collection activities related to chemical testing for all chemicals in this final rule (representing the submission ofletters ofintent or exemption applications, study plans, and the final reports; progress reports

are not required bythis final rule because testing will be completed within about 1year) would result in an annual public reporting burden of 165 hours per chemical or a total of 5,610 hours for the 34 chemicals (Ref.57).

The annual public reporting burden related to export notification is estimated to be 0.5 to 1.5 burden hours for each chemical/country combination (Ref.57). In estimating the totalburden hours approved for the information collection activities related to export notification, the Agency has included sufficientburden hours to accommodate
any export notifications that maybe required bythe Agency's issuance of final chemical test rules (Refs. 57, 60, and 61).

For each manufacturer ofthe 34 chemicals identified in the economic analysis, the parent company (ultimate corporate entity, or UCE) was also identified. The economic analysis identified atotal of 84 UCEs that EPA believes would be the likely respondents to the final rule. The public reporting burden for this collection of information is estimated to average 165 hours per chemical. Multiplyingby 34 chemicals (34x 165 = 5,610 hours total), and dividing by 84 UCEs, results in a per respondent estimated burden of66.8 hours. This burden estimate includes time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing andreviewing the collection ofinformation.

As defined byPRA and 5CFR 1320.3(b), "burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose orprovide information to orfor aFederal Agency. This includes the time needed to: Review instructions; develop, acquire, install, and utilize technology and systems for the purposes ofcollecting, 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 which have subsequently changed; train personnel to be able to respond to a collection ofinformation; search data sources; complete and review the collection ofinformation; and transmit orotherwise disclose the information.

Under PRA, an agency may not conduct or sponsor, and a person is not required to respond to, an information collection request unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and included on the related collection instrument. EPA is amending the table in 40 CFR part 9 to listthe OMB approval number for the information collection requirements contained in this final rule. This listing ofthe OMB control numbers and their subsequent codification in the CFR satisfies the display requirements ofPRA and OMB's implementing regulations at 5CFR part 1320. This ICR was previously subject to public notice and comment prior to OMB approval, and given the technical
nature ofthe table, EPA finds that further notice and comment to amend it is unnecessary. As aresult, EPA finds that there is "good cause" under section 553(b)(1)(B) ofthe Administrative Procedure Act, 5U.S.C. 553(b)(1)(B), to amend this table without further notice and comment.

B. RegulatoryFlexibility Act (RFA)
Pursuant to section 605(b) ofthe Regulatory Flexibility Act (RFA), 5 U.S.C. 601 etseq., the Agency hereby certifies that this final rule will not have

a significant adverse economic impact

on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity impact analysis prepared as part ofthe economic analysis for this final rule (Ref. 57), and is briefly summarized here.

Three factors are examined in EPA's small entity assessment (Ref.57) in order to characterize the potential small entity impacts ofthisfinal rule:

* The size ofthe adverse impact (measured as the ratio ofthe cost to sales or revenue).

* The total number ofsmall entities that experience the adverse impact.

* The percentage ofthe total number ofsmall entities that experience the adverse impact.

Section 601(3) ofRFA establishes as the default definition of "small business" the definition usedin section 3 ofthe Small Business Act, 15 U.S.C. 632, under which the SBA establishes small business size standards for each industry sector. (13 CFR 121.201). For this final rule, EPA has analyzed the potential small business impacts using the size standards established under this default definition. The SBA size standards, which are primarily intended
to determine whether a business entity is eligible for government programs and preferences reserved for small businesses (13 CFR 121.101), "seek to

ensure that a concern that meets a specific size standard is not dominant in its field ofoperation." (13 CFR 121.102(b)). See section 632(a)(1) ofthe Small Business Act. Industrial sectors

are identified by a NAICS code. In most
cases, SBA has specified an employee size standard (100; 500; 750; 1,000; or 1,500 employees) or, in some cases, a sales-based, or other industry-specific indicator, cut-offbelow which an entity in thatparticular NAICS code would be considered small (Ref.59).

The SBA employee size standards that apply to most ofthe NAICS codes that

are potentially impacted (Ref.57) by this final rule range from 500 to 1,500 employees. Size standards for three potentially affected non-manufacturing NAICS are defined in terms of sales, and in each case the standards are $5 millionin annual sales, while the standards for the set ofpossible NAICS where another entity is likelyto fall, are expressed in terms ofelectricity generating capacity (4 million megawatt hours).

Sales and employment data were obtained for the 84 UCEs that manufacture the 34 chemicals subject to this final rule to identify those UCEs that qualify for "small business" status, where data were available. Based on the SBA size standards for the NAICS codes that applied to those UCEs, 25 ofthe 84 UCEs (30%) were identified as small. The significance ofthis final rule's impact on these small businesses was analyzed by examining the number of small entities that experienced different levels ofcosts as apercentage oftheir sales. In such an analysis, small businesses are placed in the following 22434

HeinOnline -- 69 Fed. Reg. 22434 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

categories on the basis ofcost-to-sales ratios: less than 1.0%, 1.0% but less than 3.0%, and 3.0% or greater. Ofthe 25 companies thatqualified for small business status according to the SBA size standards, none had a cost-to-sales ratio that exceeded 1.0%. Given these results, EPA concludes that there isnot

a significant economic impact on these small entities as a result ofthisfinal rule.

There were an additional seven UCEs for which the NAICS code, sales, and employment data were not available. Because ofthis, EPA could not determine whether they are small businesses or assess the potential impacts ofthe test rule on them. However, it is very unlikely that all

seven ofthese UCEs are small entities. Moreover, given the Agency's analysis for the identified smallbusinesses, which concluded that there is not a significant economic impact on any of them, EPAbelieves itis reasonable to conclude thateven if some ofthese

seven UCEs are small entities, they will
not experience a significant economic impact. Consequently, EPA concludes that there will not be a significant economic impact on a substantial number ofsmall entities as a result of this final rule.

In analyzing potential impacts on small entities, RFA recognizes that it may be appropriate at times to use an alternate definition of small business. As such, section 601(3) ofRFA provides that an agency may establish a different definition ofsmall business after consultation with the SBA Office of Advocacy and after notice and an opportunity for public comment. Even though the Agency has used the default SBAdefinition ofsmall business to conduct its analysis ofpotential small entity impacts for this final rule, EPA does not believe that the SBA size standards are generally the best standards to use in assessing potential impacts ofTSCA section 4(a) test rules

on small entities. EPA believes that a standard based on total annual sales, such as the definition found in TSCA (40 CFR 704.3), may provide a more appropriate means to determine the ability of a chemical manufacturing firm
to support testing without significant
costs or burdens. EPAis determining what level of annual sales would provide the most appropriate size cutoff with regard to various segments ofthe chemical industry usually impacted by TSCA section 4(a) test rules, but has not yet reached adetermination. Therefore,

as previously stated in this unit, the RFA determination for this final rule is based onan analysis using the default SBA size standards. In the proposal to this rule, EPArequested comment on whether the Agency should establish an alternate small business definition to

use in small entity impact analyses for future TSCA section 4(a) test rules, and what size cutoffmay be appropriate. The comment received onthis subject and the Agency's response are in Unit III.K.

Although EPAhas not yet pursued the establishment ofan alternate definition for use in the analysis conducted for this final rule, the analysis does present the results of calculations using a standard based on total annual sales. Under the TSCA definition at 40 CFR 704.3, a firm is classified as small ifit has either total annual sales below $40 million and annual production or importation volume less than or equal to 100,000 pounds, or, annual sales below $4 million. Ofthe 84 UCEs subject to the final rule, a maximum of9 can be classified as small under the TSCA definition, with data unavailable for an additional 7firms. None ofthose 9 firms will be affected at the level of 1.0% or greater. Impacts could not be determined for the 7firms whose size

was unknown, but as with the analysis conducted using the SBA size standards, the Agency believes it is reasonable to conclude that under the referenced TSCA definition of small, the 7UCEs will not experience significant economic impacts as a result ofthe final rule.

The estimated costs ofthe TSCA section 12(b) export notification, which,

as aresult ofthis final rule, wouldbe required for the first export to a particular country of a chemical subject
to the rule, is estimated to be $61.31 for the first time that an exporter must comply with TSCA section 12(b) export notification requirements, and $18.07 for each subsequent export notification submitted by that exporter (Refs. 57, 60, and 61). EPA has concluded that the
costs ofTSCA section 12(b) export notification would have a negligible impact on exporters ofthe chemicals in this final rule, regardless ofthe size of the exporter.

Therefore, the Agency certifies that this final rule will not have a significant adverse economic impact on a substantial number ofsmall entities.

C. UnfundedMandatesReformAct

Pursuant to Title II ofthe Unfunded Mandates Reform Act of1995 (Public Law 104-4), EPA has determined that this regulatory action does not contain

aFederal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector in any 1year. The analysis ofthe costs associated with this action are described in Unit VIII. In addition, since EPA does
nothave any information to indicate that any State, local, or tribal government manufactures or processes the chemicals covered bythis action such that this final rulewould apply directly to State, local, or tribal governments, EPA has determined that this final rule does not significantly or uniquely affect small governments. Accordingly, this final rule is not subject to the requirements of sections 202, 203, 204, and 205 ofUMRA.

D.Executive Order13132

Executive Order 13132, entitled Federalism(64FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure 'meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications." "Policies that have federalism implications" is defined in the Executive order to include regulations that have "substantial direct effects on the States, onthe relationship between the national government and the States, or onthe distribution of
power and responsibilities among the various levels ofgovernment."

This final rule does nothave federalism implications. Itwill not have substantial direct effects on the States,

on the relationship between the national government and the States, or on the distribution ofpower and responsibilities among the various levels of government, as specified in Executive Order 13132. This final rule establishes testing and recordkeeping requirements that apply to manufacturers (including importers) and processors ofcertain chemicals. Because EPAhas no information to indicate that any State orlocal government manufactures or processes the chemical substances covered bythis action, this final rule does not apply directly to States and localities andwill
not affect State andlocal governments. Thus, Executive Order 13132 does not apply to this final rule. Although Executive Order 13132 was not yet in effect when EPA developed the proposed rule, its predecessor, Executive Order 12875, was andEPA's conclusions under Executive Order 13132 are consistent with EPA's considerations under Executive Order 12875.

E.Executive Order13175

Under Executive Order 13175, entitled ConsultationandCoordination withIndian TribalGovernments(65 FR 67249, November 6, 2000), thisfinal rule does not have tribal implications 22435

HeinOnline -- 69 Fed. Reg. 22435 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

because it will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution ofpower and responsibilities between the Federal Government and Indian tribes, as specified in the Order. As indicated above, EPA has no information to indicate that any tribal government manufactures or processes the chemical substances covered by this action. Thus, Executive Order 13175 does not apply
to this final rule. Although Executive Order 13175 was notyet in effect when EPA developed the proposed rule, its predecessor, Executive Order 13084,

was and EPA's conclusions under Executive Order 13175 are consistent with EPA's considerations under Executive Order 13084.

F.Executive Order13045

This final rule does not require special consideration pursuant to the
terms ofExecutive Order 13045, entitled ProtectionofChildren from EnvironmentalHealthRisks andSafety Risks (62 FR 19885, April 23, 1997), because it is not likely to have an annual effect onthe economy of$100 million or more and it does not have a potential effect or impact on children. This final rule establishes testing and recordkeeping requirements thatapply
to manufacturers (including importers) andprocessors of certain chemicals, and will result in the production of information that will assist the Agency and others in determining whether the chemical substances in this final rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

G. Executive Order13211

This final rule isnot a "significant energy action" as defined in Executive Order 13211, Actions Concerning RegulationsThatSignificantly Affect EnergySupply,Distribution,or Use(66 FR 28355, May 22, 2001) because it is
not likely to have a significant adverse effect onthe supply, distribution, or use ofenergy. As such, the Agency has concluded that this final rule is not likely to have adverse energy effects.

H. NationalTechnology Transferand AdvancementAct

As noted in the proposed rule, section 12(d) ofthe National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113 section 12(d) (15 U.S.C 272 note) directs EPA to

use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary

consensus standards are technical standards (e.g., materials specifications,
test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA toprovide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.

Because this final rule involves technical standards, the Agency conducted a search to identify potentially applicable voluntary

consensus standards. No such standards

were identified and none were brought
to the Agency's attention in comments. Therefore, EPA has decided to use the in vitrodermal absorption rate test standard finalized in this document. This standard was based onthe peer reviewed method ofBronaugh and Collier which was published in 1991 (Ref. 13) andrefined by a panel of Federal scientists from ITC member and liaison agencies (including,for example, CPSC, DoD, EPA, FDA, NIOSH, and OSHA). The method was further refined by this panel in response to public
comments.

L Executive Order12898

Pursuant to Executive Order 12898, entitled Federal Actions toAddress EnvironmentalJusticeinMinority PopulationsandLow-Income Populations(59 FR 7629, February 16, 1994), the Agency has considered environmental justice-related issues with regard to the potential impacts of this action onthe environmental and health conditions in minority and lowincome populations. The Agency believes that the information collected under this final rule will assist EPA and others in determining the hazards and risks associated with the chemicals covered by the final rule. Although not directly impacting environmental justice-related concerns, this information will better enable the Agency toprotect human health and the environment.

J.Congressional ReviewAct
The Congressional Review Act, 5 U.S.C. 801 etseq., generally provides that before a rule may take effect, the Agency promulgating the rule must submit arule report to each House of the Congress and the Comptroller General ofthe United States. EPA will submit areport containing this rule and otherrequired information to the U.S. Senate, the U.S. House of Representatives, andthe Comptroller General ofthe United States prior to publication ofthe rule in the Federal Register. This rule is not a "major rule"

as defined by 5 U.S.C. 804(2).

List ofSubjects

40 CFRPart9

Environmental protection, Reporting and recordkeeping requirements. 40 CFRPart799

Environmental protection, Chemicals, Hazardous substances, Laboratories, Reporting and recordkeeping requirements.

Dated:April 4, 2004. Susan B.Hazen, ActingAssistantAdministrator,Officeof Prevention,PesticidesandToxicSubstances.

* Therefore, 40 CFR chapter Iis amended as follows:

m1. By amendingpart 9 asfollows:

PART 9-[AMENDED]

* a. The authority citation for part9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 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, 1318, 1321, 1326, 1330, 1342, 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 et seq., 6901-6992k,7401-7671q,7542, 9601-9657, 11023, 11048.

* b.In §9.1, the table is amended by adding an entry for §799.5115 in numerical order under the indicated heading to read as follows:
§9.1 OMB approvals under the Paperwork Reduction Act.

40 CFRcitation OMB control No.

Identification of Specific Chemical Substance and Mixture Testing Requirements

799.5115

............................... 2070-0033

* 2. By amendingpart 799 asfollows:

PART 799-[AMENDED]

* a. The authority citation for part 799 continues to read as follows:

Authority: 15 U.S.C. 2603, 2611, 2625.

* b.By adding §799.5115 to subpart D

to read as follows: 

### 22436

HeinOnline -- 69 Fed. Reg. 22436 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

§799.5115 Chemical testing requirements forcertain chemicalsof interesttothe Occupational Safety and Health Administration. (a) Whatsubstanceswillbe tested underthissection?Table 2in paragraph (j)ofthis section identifies the chemical substances that mustbe tested under this section. Forthe chemical substances identified as "Class 1" substances in Table 2in paragraph (j)of this section, the purity ofeach chemical
substance must be 99% or greater, unless otherwise specified in this section. Forthe chemical substances identified as "Class 2" substances in Table 2in paragraph (j)of this section,

arepresentative form ofeach chemical substance must be tested. (b)Am Isubjectto this section?(1)If you manufacture (including import) or intend to manufacture, orprocess or intend to process, any chemical substance listed in Table 2in paragraph (j) ofthis section at any time from May 26, 2004, to the end ofthe test data reimbursement period as defined in 40 CFR 791.3(h), you are subject to this section with respect to that chemical substance.

(2)Ifyou donot know or cannot reasonably ascertain that you manufacture or process a chemical substance listed in Table 2in paragraph (j) ofthis section during the time period described in paragraph (b)(1) ofthis section (based on allinformation in your possession or control, as well as all information that areasonable person similarly situated might be expected to possess, control, or know, or could obtain without an unreasonable burden), you are not subject to this section with respect to that chemical substance.

(c) IfIamsubjectto this section, when

mustIcomply with it?(1)(i) Persons subject to this section are divided into
two groups, as setforth in Table 1of this paragraph: Tier 1 (personsinitially required to comply) and Tier 2 (persons
notinitially required to comply). Ifyou

are subject to this section, you must determine ifyou fall within Tier 1 or Tier 2,based on Table 1 ofthis paragraph.

TABLE 1.- PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 

### 2

Persons initially required to comply with this Persons not initially required to comply with this section (Tier 2) section (Tier 1)

Persons not otherwise specified in column 2 of A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a

this table that manufacture (as defined at chemical substance included in this section solely as one or more of thefollowing: TSCA section 3(7)) or intend to manufacture -As a byproduct (as defined at 40 CFR 791.3(c));

a chemical substance included in this sec- -As an impurity (as defined at 40 CFR 790.3); tion. -As a naturally occurring substance (as defined at 40 CFR 710.4(b)); -As a non-isolated intermediate (as defined at 40 CFR 704.3); -As a component of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i)); -In amounts of less than 500 kilograms (kg) (1,100 Ibs) annually (as described at 40 CFR

790.42(a)(4)); or -For research and development (as described at 40 CFR 790.42(a)(5)). B. Persons who process (as defined at TSCA section 3(10)) or intend to process a chemical

substance included in this section (see 40 CFR 790.42(a)(2)).

(ii)Table 1in paragraph (c)(1)(i) of this section expands the listofpersons specified in §790.42(a)(2), (a)(4), and (a)(5) ofthis chapter, who, while legally subject to this section, must comply with the requirements ofthis section onlyifdirected to do so by EPAunder the circumstances set forth in paragraphs (c)(4) through (c)(7) and (c)(10) ofthis section.

(2)Ifyou are in Tier 1with respect to a chemical substance listed in Table 2in paragraph (j) ofthis section, you must, for each test required under this section for that chemical substance, either submit to EPA a letter ofintent
to test or apply to EPA for an exemption from testing. The letter ofintent to test

orthe exemption application mustbe received byEPA no later thanJune 25, 2004.

(3)Ifyou are in Tier 2with respect to a chemical substance listed in Table 2in paragraph (j) ofthis section, you are considered to have an automatic conditional exemption and you willbe required to comply with this section with regard to thatchemical substance onlyifdirected to do so by EPAunder paragraphs (c)(5), (c)(7), or (c)(10) ofthis section. (4) Ifno person in Tier 1has notified EPA ofits intent to conduct one or more ofthe tests required by this section on any chemical substance listed in Table 2in paragraph (j) ofthis section byJune 25, 2004, EPA will publish a Federal Register document that would specify the test(s) and the chemical substance(s) for which no letter ofintent has been submitted, and notify manufacturers in Tier 2A oftheir obligation to submit a letter ofintent to test orto apply for an exemption from testing.

(5)Ifyou are in Tier 2A with respect to a chemical substance listed in Table 2in paragraph (j) ofthis section, and if
you manufacture this chemical substance as ofMay 26, 2004, orwithin 30 days afterpublication ofthe Federal Register document described in paragraph (c)(4) ofthis section, you must, for each test specified for that chemical substance in the document described in paragraph (c)(4) ofthis section, either submitto EPA aletter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than 30 days after publication of the document described inparagraph (c)(4) ofthis section.

(6) Ifno manufacturer in Tier 1 orTier 2A has notified EPA ofits intent to conduct one or more ofthe tests required by this section on any chemical substance listed in Table 2in paragraph (j) ofthis section within 30 days after the publication ofthe Federal Register document described in paragraph (c)(4) ofthis section, EPA will publish another Federal Register document that would specify the test(s) and the chemical substance(s) for which no letter ofintent has been submitted, and notify
processors in Tier 2B oftheir obligation
to submit a letter ofintent to test or to apply for an exemption from testing.

(7)Ifyou are in Tier 2B with respect to a chemical substance listed in Table 2in paragraph (j) ofthis section, and if
you process this chemical substance as ofMay 26, 2004, orwithin 30 days after publication ofthe Federal Register document described in paragraph (c)(6) ofthis section, you must, for each test specified for that chemical substance in the document described inparagraph (c)(6) ofthis section, either submit to EPA a letter ofintentto test or apply to EPA for an exemption from testing. The 

### 22437

HeinOnline -- 69 Fed. Reg. 22437 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

letter ofintent to test or the exemption application must be received by EPA no later than 30 days after publication of the document described in paragraph (c)(6) ofthis section.

(8) Ifno manufacturer or processor has notified EPA ofits intent to conduct

one or more ofthe tests required by this section for any ofthe chemical substances listed in Table 2in paragraph (j)ofthis section within 30 days after the publication ofthe Federal Register document described in paragraph (c)(6) ofthis section, EPA will notify all manufacturers and processors ofthose chemical substances ofthis fact by certified letter orby publishing a Federal Register document specifying the test(s) for which no letter ofintent has been submitted. This letter or Federal Register document will additionally notify allmanufacturers andprocessors that all exemption applications concerning the test(s) have been denied, and will give the manufacturers andprocessors ofthe chemical substance(s) an opportunity to take corrective action. (9) Ifno manufacturer or processor has notified EPA ofits intent to conduct

one or more ofthe tests required by this section for any ofthe chemical substances listed in Table 2in paragraph (j)ofthis section within 30 days after receipt ofthe certified letter

orpublication ofthe Federal Register document described in paragraph (c)(8) ofthis section, all manufacturers and
processors subject to this section with respect to that chemical substance who

are not already in violation ofthis section will be in violation ofthis section.

(10) Ifa problem occurs with the initiation, conduct, or completion ofthe required testing or the submission ofthe required data with respect to a chemical substance listed in Table 2in paragraph (j)ofthis section, under the procedures in §§790.93 and 790.97 ofthis chapter, EPA may initiate termination proceedings for all testing exemptions with respect to that chemical substance and may notify persons in Tier 1 and Tier 2that they are required to submit letters ofintent to test or exemption applications within a specified period of time. (11) Ifyou are required to comply with this section, but your manufacturing or processing ofa chemical substance listed in Table 2in paragraph (j)ofthis sectionbegins after the applicable compliance date referred
to in paragraphs (c)(2), (c)(5), (c)(7), or (c)(10) ofthis section, you must either submit aletter ofintent to test or apply
to EPA for an exemption. The letter of intent to test or the exemption application must be received by EPA no later than the day you begin manufacturing orprocessing. (d) WhatmustIdo to comply with thissection?(1)To comply with this section you must either submit to EPA

aletter ofintent to test, or apply to and obtain from EPA an exemption from testing. (2)For each test with respect to which you submitto EPA aletter ofintent to test, you must conduct the testing specified in paragraph (h)ofthis section and submitthe test data to EPA.

(3)You must also comply with the procedures governing test rule requirements in part 790 ofthis chapter,

as modified by this section, including the submission ofletters ofintent to test

or exemption applications, the conduct oftesting, and the submission of data; Part 792-Good Laboratory Practice Standards ofthis chapter; and this section. The following provisions of40 CFR part 790 do not apply to this section: Paragraphs (a), (d), (e), and (f) of§790.45; paragraph (a)(2) and paragraph (b) of §790.80; and §790.48. (e) IfIdonot complywith thissection, when willIbe considered in violation of it?You will be considered in violation ofthis section as of 1day after the date by which you arerequired to comply with this section. (f)HowareEPA's datareimbursement proceduresaffectedforpurposesofthis section?Ifpersons subject to this section

are unable to agree onthe amount or method ofreimbursement for test data development for one ormore chemical substances included in this section, any person may request ahearing as described in 40 CFR part 791. In the determination offair reimbursement shares under this section, ifthe hearing officer chooses to use a formula based

onproduction volume, the total production volume amount will include
amounts ofa chemical substance produced as an impurity. (g) Who mustcomply with theexport notificationrequirements? Any person who exports, orintends to export, a chemical substance listed in Table 2in paragraph (j) ofthis section is subject to part 707, subpart D, ofthis chapter. (h)HowmustIconductmy testing? The chemical substances identified by Chemical Abstract Service Registry Number (CASNo.) and chemical name in Table 2in paragraph (j)ofthis section
must be tested as follows: (1)Applicability.This in vitro dermal absorption rate test standard must be used for alltesting conducted under this section. In certain instances, modifications to the test standard may be considered. The procedures for applying for a modification to the test standard are specified in 40 CFR 790.55.

(2)Source.The test standard is based

on the Protocol for In Vitro Percutaneous Absorption Rate Studies, referenced in paragraph (h)(8)(v) ofthis section.

(3)Purpose.In the assessment and evaluation ofthe characteristics ofa chemical substance ormixture for which testing is required under this section (test substance), it is important
to determine the rate of absorption of the test substance in cases where dermal
exposure to the test substance in the workplace may result in systemic toxicity. This test standard is designed
to develop data that describe the rate at which test substances are absorbed through the skin so that the body burden ofa test substance resulting from dermal exposure in the workplace can be better evaluated. (4) Principlesoftheteststandard. Thistest standard describes procedures for measuring a permeability constant (Kp) and two short-term dermal absorption rates for test substances in liquid form. The test standard utilizes in vitrodiffusion cell techniques which allow absorption studies to be conducted with human cadaver skin. In vitrodiffusion studies are necessary for measuring a Kp. This test standard specifies the use of static or flowthrough diffusion cells and non-viable human cadaver skin. It also requires the

use ofradiolabeled test substances unless it can be demonstrated that procedures utilizing anon-radiolabeled
test substance are able to measure the
test substance with a sensitivity equivalent to the radiolabeled method.

(5) Testprocedure-(i)Choiceof membrane-(A)Skin selection.Human cadaver skin must be used in all testing conducted under this test standard.This
test standard does not require use oflive skin, or the maintenance of skin viability during the course ofthe experiment. However, the time elapsed between death and harvest oftissue
mustbe reported.

(B) Numberofskin samples.Data for the determination of aKp must be obtained from a minimum ofsix skin samples and the skin samples must

come from at least three different human subjects (two skin samples from each subject) in order to allow for biological variation between subjects. Datafor the determination ofeach shortterm (i.e., 10 minute and 60 minute) absorption rate must be obtained from a minimum of six skin samples and the skin samples must come from at least three different human subjects (two skin samples from each subject). 

### 22438

HeinOnline -- 69 Fed. Reg. 22438 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

(C)Anatomicalregion.In order to minimize the variability in skin absorption measurements for these tests, samples ofhuman cadaver skin mustbe obtained from the abdominal region of human subjects ofknown source and disease state.

(D) Validationofhumancadaverskin barrier. Prior to conducting an experiment with the test substance, barrier properties ofhuman cadaver skinmust be pretested either by:

(1)Measuring the absorption ofa standard compound such as tritiated
water as discussed, for example, in the reference in paragraph (h)(8)(i) ofthis section;

(2) Determining an electrical resistance to an alternating current, at up to two volts; or (3) Measuring trans-epidermal water loss from the stratum corneum. (ii)Preparation ofmembrane.Full thickness skin must notbe used. A suitable membrane must be prepared from skin either with a dermatome at a thickness of200 to 500 micrometers (um), or with heat separation bytreating the skin at 600 C for 45 seconds to 2 minutes after which the epidermis can be peeled from the dermis. These epidermal membranes canbe stored frozen (-20' 

### C)for up to 3months, if
necessary, ifthey are frozen quickly and the barrier properties ofthe samples are confirmed immediately prior to commencement ofthe experiment.

(iii)Diffusion celldesign.Either static

orflow-through diffusion cells must be used in these studies. To ensure that an increase in concentration ofthe test substance in the receptor fluid does not alterpenetration rate, the testing laboratory must verify that the concentration ofthe test substance in the receptor fluid is less than 10% ofthe initial concentration in the donor chamber. Concentration ofthe neat (i.e., undiluted) liquid must be taken as the density ofthe test substance.

(iv) Temperature.Skin must be maintained at a physiological temperature of320 C duringthe test. (v)Testinghydrophobicchemicals. When testing hydrophobic chemicals, polyethoxyoleate (polyethylene glycol (PEG) 20 oleyl ether) must be added to the receptor fluid at a concentration of 6%.

(vi) Vehicle.Ifthe test substance is a liquid at room temperature and does not damage the skin during the determination ofKp, itmust be applied
neat. Ifthe test substance cannot be applied neat because it is a solid at

room temperature orbecause it damages the skin when applied neat, itmust be dissolved in water. Ifthe concentration ofa hydrophobic test substance in water is not high enough so that a steady-state absorption can be obtained, the test substance must be dissolved in isopropyl myristate. A sufficient volume ofliquid must be used to completely

cover the skin and provide the amount oftest substance as described in paragraph (h)(5)(vii) ofthis section. (vii)Dose-(A)Kp. AKp must be determined for each test chemical. An "infinite dose" ofthe test substance
must be applied to the skinto achieve the steady-state rate of absorption necessary for calculation ofa Kp. Infinite dose is defined as the concentration of atest substance required to give an undepletable reservoir onthe surface ofthe skin. The actual concentration required to give an undepletable reservoir on the surface of the skin depends onthe rate of penetration ofthe test substance. Preliminary studies may be necessary to determine this concentration. Percutaneous absorption must be determined under occluded (i.e., covered) conditions unless itis demonstrated that such conditions

cause leakage ofmaterial or damage to the skin membrane as a result of unrealistically high pressures or excessive hydration. Skin barrier integrity must be verified atthe end of the experiment by the methods discussed in paragraph (h)(5)(i)(D) of this section. (B) Short-termabsorptionrates.Shortterm absorption rates must be determined for alltest chemicals. The dose oftest chemical applied to the skin
must be sufficient to completely cover the exposed skin surface. Aminimum of four diffusion cells must be setup using skinfrom a single subject. Two diffusion cells mustbe terminated at 10 minutes. The remaining two diffusion cells must be terminated at60 minutes. Skin absorption ateach sampling time is the sum ofthe receptor fluid levels and the absorbed test substance that remains in the skin, as discussed, for example, in the reference in paragraph (h)(8)(iii) ofthis section. Unabsorbed chemical must be removed from the skin surface by washing gently with soap and water. This experiment must be repeated with skin from two additional subjects. In order to ensure reliable short-term absorption rates, percutaneous absorption must be determined under occluded conditions unless it is demonstrated that such conditions cause leakage ofmaterial or damage to the skin membrane as aresult ofunrealistically high pressures or excessive hydration.

(viii)Study duration-(A)Kp.The in vitrodermal absorption rate test mustbe performed until atleast four absorption measurements per diffusion cell experiment are obtained during the steady-state absorption portion ofthe experiment. Apreliminary study may be usefulto establish time points for sampling. The required absorption
measurements canbe accomplished in

an hour or two with fast-penetrating chemicals but may require 24 hours or longer for slow-penetrating chemicals. Unabsorbed test substance need not be removed from the surface ofthe skin after each experiment.

(B) Short-termabsorptionrates.The
test substance mustbe applied to skin for durations of 10 and 60 minutes. At the end ofthe study, the unabsorbed test substance mustbe removed from the surface ofthe skinwith soap andwater and the amount absorbed into the skin and receptor fluid must be determined,

as discussed, for example, in the reference in paragraph (h)(8)(iii)ofthis section.

(6) Results-(i)Kp. The Kp must be calculated by dividing the steady-state
rate ofabsorption (measured in micrograms (ug)xhr-1x centimeters (cm) - 2) bythe concentration ofthe test substance (measured in ugx cm - 3) applied to the skin. (For example, ifthe steady-state rate is 1microgram x hr1x cm - 2 and the concentration applied to the skin is 1,000 micrograms x cm -3 , thenthe Kp value is calculated to be 0.001 cmx hr-1.) The mean and standard deviation ofthe calculated Kp values for all diffusion cell experiments must be determined.

(ii) Short-termabsorptionrate.The absorption rates (ugx hr- x cm -2) must be determined from the total amount of
test substance foundin the receptor fluid and skin after the 10-minute and 60-minute exposures for each diffusion cell experiment. The mean and standard deviation of 10-minute short-term absorption rates from all experiments
mustbe calculated. The mean and standard deviation of60-minute shortterm absorption rates from all experiments must also be calculated.

(7) Testreport.In addition to compliance with the TSCA Good Laboratory Practice Standards (GLPS) at 40 CFR part 792, the following specific information must be collected and reported by the date in paragraph (i) of this section:

(i) Testsystems andtestmethods.(A) Adescription ofthe date, time, and location ofthe test,the name(s) ofthe person(s) conducting the test, the location ofrecords pertaining to the test,

as well as a GLPS statement. These
statements must be certified bythe signatures ofthe individuals performing the work andtheir supervisors. 

### 22439

HeinOnline -- 69 Fed. Reg. 22439 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

(B) Adescription ofthe source, identity, and purity ofthe test substance and the source, identity, and handling ofthe test skin. There must be a detailed description ofthe test procedure and all materials, devices used and doses tested, as well as a detailed description and illustration ofstatic or flow-through cell design. There must also be a description ofthe skin preparation method, including measurements ofthe skinmembrane thickness.

(C) Adescription ofthe analytical techniques to be used, including their accuracy, precision, and detection limits (inparticular for non-radiolabeled tests), and, ifa radiolabel is used, there must be a description ofthe radiolabel (e.g., type, location of, and radiochemical purity ofthe label). (D) All data mustbe clearly identified

as to dose and specimen. Derived values (means, permeability coefficient, graphs, charts, etc.) are not sufficient.

(ii) Conductofstudy.Data must be collected and reported on the following:

(A)Monitoring oftesting parameters. (B) Temperature ofchamber. (C) Receptor fluid pH. (D) Barrier property validation. (E) Analysis ofreceptor fluid for radioactivity ortest chemical (iii)Results.The mean Kp andmean short-term absorption rates must be presented along with their standard deviations and the number ofdiffusion cell experiments. In addition, all raw data from each individual diffusion cell
must be retained to support the calculations ofpermeability constants and short-term absorption rates. When a radiolabeled test substance is used, a full balance ofthe radioactivity must be presented, including cell rinsing and stability ofthe test substance in the donor compartment.

(8) References.For background information on this test standard, the following references may be consulted. These references are available under docketID number OPPT-2003-0006 at the EPA Docket Center, Rm. B102- Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. (i) Bronaugh, R.L., Stewart, R.F., and Simon, M. Methods for In Vitro Percutaneous Absorption Studies VII: Use ofExcised Human Skin. Journalof Pharmaceutical Sciences. 75:1094- 1097. 1986.

(ii)Bronaugh, R.L. and Stewart, R.F. Methods for In VitroPercutaneous Absorption Studies IV: The FlowThrough Diffusion Cell. Journalof Pharmaceutical Sciences. 74:64-67. 1985.

(iii)Bronaugh, R.L., Stewart, R.F., and Storm,J.E. Extent ofCutaneous Metabolism During Percutaneous Absorption ofXenobiotics. Toxicology andAppliedPharmacology. 99:534- 543. 1989.

(iv)Walker, J.D., Whittaker, C. and McDougal, J.N. Role ofthe TSCA Interagency Testing Committee in Meeting the U.S. Government Data Needs: Designating Chemicals for Percutaneous Absorption Rate Testing. Dermatotoxicology. F. Marzulli and H. Maibach, Eds. Taylor &Francis, Washington, DC. pp. 371-381. 1996.

(v)Bronaugh, R.L., and Collier, S.W. Protocol forIn Vitro Percutaneous Absorption Studies. In Vitro Percutaneous Absorption:Principles, Fundamentals, andApplications.R.L. Bronaugh and H.I. Maibach, Eds. CRC Press, Boca Raton, FL.pp. 237-241. 1991.

(i)Reportingrequirements.The reports submitted under this section
must include the information specified in paragraph (h)(7) ofthis section. A final report for each chemical substance
mustbe received by EPAbyJune 27, 2005, unless an extension is granted in writing pursuant to 40 CFR 790.55.

(j) Designationofspecificchemical substances for testing.The chemical substances identified by chemical name, CASNo., and class in Table 2 ofthis paragraph mustbe testedin accordance with the testing requirements in paragraph (h)ofthis section and the requirements described in 40 CFR part 792.

TABLE 2.-CHEMICAL SUBSTANCES DESIGNATED FOR TESTING

CAS No. Chemical name Class

75-05-8 Acetonitrile 1

75-15-0 Carbon disulfide 1

75-35-4 Vinylidene chloride 1

77-73-6 Dicyclopentadiene 1

77-78-1 Dimethyl sulfate 1

78-59-1 Isophorone 1

78-87-5 Propylene dichloride 1

79-20-9 Methyl acetate 1

79-46-9 2-Nitropropane 1

91-20-3 Naphthalene 1

92-52-4 Biphenyl 1

98-29-3 tert-Butylcatechol 1

100-00-5 p-Nitrochlorobenzene 1

100-01-6 p-Nitroaniline 1

100-44-7 Benzyl chloride 1 22440

HeinOnline -- 69 Fed. Reg. 22440 2004Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

TABLE 2.-CHEMICAL SUBSTANCES DESIGNATED FOR TESTING-Continued

CAS No. Chemical name Class

106-42-3 p-Xylene 1

106-46-7 p-Dichlorobenzene 1

107-06-2 Ethylene dichloride 1

107-31-3 Methyl formate 1

108-03-2 1 -Nitropropane 1

108-90-7 Chlorobenzene 1

108-93-0 Cyclohexanol 1

109-66-0 Pentane 1

109-99-9 Tetrahydrofuran 1

110-12-3 Methyl isoamyl ketone 1

111-84-2 Nonane 1

120-80-9 Catechol 1

122-39-4 Diphenylamine 1

123-42-2 Diacetone alcohol 1

127-19-5 Dimethyl acetamide 1

142-82-5 n-Heptane 1

150-76-5 p-Methoxyphenol 1

25013-15-4 Vinyl toluene 2

34590-94-8 Dipropylene glycol methyl ether 2

(k)Effective dateThis section is effective on May 26, 2004.
[FRDoc. 04-9409 Filed 4-23-04; 8:45 am]

BILLING CODE 6560-50-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52 [CA083-0436a; FRL-7650-4]

Revisionsto the California State Implementation Plan, San Joaquin Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule.

SUMMARY: EPA is taking direct final action to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). The revisions concern stack monitoring, source sampling, and the emission ofvolatile organic compounds from bakery ovens. We are approving local rules that are administrative or regulate this emission source under the Clean Air Act as amended in 1990 (CAA

orthe Act).
DATES: This rule is effective on June 25, 2004 without further notice, unless EPA receives adverse comments by May 26, 2004. Ifwe receive such comments, we will publish atimely withdrawal in the Federal Register to notify the public that this rule will not take effect.

ADDRESSES: Send comments to Andy Steckel, Rulemaking Office Chief (AIR4), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne Street, SanFrancisco, CA 94105, or email to steckel.andrew@epa.gov,or submit comments athttp:// www.regulations.gov.

You can inspect a copy ofthe submitted rule orrule revisions and EPA's technical support document (TSD) at our Region IX office during normal business hours. You may also

see a copy ofthe submitted rule or rule revisions andTSD at the following locations:
Environmental Protection Agency, Air

Docket (6102), Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington DC 20460 California Air Resources Board,

Stationary Source Division, Rule Evaluation Section, 1001 "I" Street, Sacramento, CA 95814 SanJoaquin Valley Unified Air

Pollution Control District, 1990 East Gettysburg Street, Fresno, CA 93726
A copy ofthe rule may alsobe available via the Internet athttp:// www.arb.ca.gov/drdb/drdbltxt.htm. Please be advised that this is not an EPA Web site and maynot contain the same version ofthe rule that was submitted

to EPA.
FOR FURTHER INFORMATION CONTACT: Al Petersen, Rulemaking Office (AIR-4), U.S. Environmental Protection Agency, Region IX, (415) 947-4118, petersen.alfred@epa.gov.

SUPPLEMENTARY INFORMATION: Throughout this document, "we," "us" and "our" refer to EPA.
Table ofContents
I.The State's Submittal

A.What rules didthe State submit? B.Are there other versions ofthese rules? 

### 22441

HeinOnline -- 69 Fed. Reg. 22441 2004