ANALYSIS OF LABORATORY CAPACITY TO SUPPORT U.S. EPA 

CHEMICAL TESTING PROGRAM INITIATIVES

October 28, 2010

Final 

Economic and Policy Analysis Branch

Economics, Exposure, and Technology Division

Office of Chemical Safety and Pollution Prevention

U.S. Environmental Protection Agency

Washington, D.C. 20460
CONTRIBUTORS

The analyst responsible for completion of this report was Lynne Blake-Hedges. Analytical and 

draft preparation support was provided by Eastern Research Group, Inc. of Lexington, 

Massachusetts under EPA Contract No. EP-W-05-014.
Table of Contents

Table of Contents.......................................................................................................................... 1

1.0 Introduction....................................................................................................................... 1

2.0 Demand for Laboratory Testing Services....................................................................... 3

2.1 Environmental Protection Agency Initiatives................................................................. 3

2.1.1 High Production Volume (HPV) Challenge Program ................................................... 3

2.1.2 Orphaned HPVs............................................................................................................. 4

2.1.3 EPA’s New Chemicals Management Program.............................................................. 4

2.1.4 Endocrine Disruptor Screening Program....................................................................... 5

2.1.5 Perfluorinated Chemical Testing ................................................................................... 6

2.2 European Chemicals Agency Requirements................................................................... 8

2.3 Food and Drug Administration Requirements.............................................................. 11

3.0 Supply of Testing Services.............................................................................................. 14

3.1 Laboratory Capabilities for SIDS ................................................................................. 14

3.2 Laboratory Capacity to Meet Demand.......................................................................... 17

3.2.1 Testing Areas with Capacity Limitations .................................................................... 17

4.0 Trends and Factors Impacting the Testing Industry................................................... 22

4.1 Emerging Markets......................................................................................................... 22

4.2 Animal Welfare Issues and Activism ........................................................................... 23

4.3 Value of the Dollar ....................................................................................................... 23

4.4 Economic Uncertainty .................................................................................................. 24

5.0 Conclusions...................................................................................................................... 25

Appendix A: SIDS Tests and Corresponding Guidelines ..................................................... A-1

Appendix B: Laboratories with SIDS Testing Capabilities.................................................. B-1
1

1.0 Introduction

The Toxic Substances Control Act (TSCA) authorizes the U.S. Environmental Protection 

Agency (EPA) to gather and review data and assess risks associated with chemicals sold and 

used in the United States. Section 4 of TSCA directs EPA to require the development of test data 

on existing chemicals when the manufacture, processing, distribution, use, or disposal of the 

chemical “may present an unreasonable risk;” or the chemical is produced in very large volume 

and there is potential for a substantial quantity to be released into the environment or for 

substantial or significant human exposure. Before it can mandate testing, however, EPA must 

find that existing data are insufficient to resolve the question of safety, and that testing is 

necessary to develop the data. In addition to mandating testing by regulation, EPA may also 

enter into consent agreements with manufacturers to conduct testing, or may employ voluntary 

approaches to collecting hazard information. 

Chemical testing driven by EPA actions represents one source of demand for the laboratory 

testing industry. Toxicological testing of chemicals is also conducted to meet commercial 

research and development needs of companies developing chemicals or drugs for the 

marketplace, or to satisfy requirements from other federal agencies and foreign governments for 

health, environmental, and safety data. Many of these testing initiatives use the same testing 

facilities and may compete for available capacity and expertise. 

The purpose of this report is to provide a snapshot of the demand for, and supply of, chemical 

testing services in areas of interest to EPA’s Office of Pollution Prevention and Toxics. It is 

important to note that the report provides neither comprehensive coverage of the entire industry 

nor does it represent a statistical sample of the industry. Rather, it is intended to provide insight 

into the current demand for laboratory testing services and the ability of laboratories to meet 

these needs. This report is an update to Analysis of Laboratory Capacity to Support U.S. EPA 

Chemical Testing Program Initiatives completed in August 2004 (hereafter referred to as the Lab 

Capacity Report). Additionally, separate assessments entitled Laboratory Testing of Chemicals 

for Endocrine Disruption Potential–Analysis of Market Factors1 and Laboratory Industry 

Capacity to Conduct Health and Environmental Testing of Nanoscale Materials2

assess 

laboratory capacity to conduct testing of chemicals for endocrine disruptor potential and 

nanoscale materials, respectively. 

This report was prepared using published information compiled for EPA about the chemical 

testing industry, discussions with EPA and other experts familiar with the industry, and 

information collected first hand from laboratories exhibiting at the Society of Toxicology’s 

ToxExpo in March of 2009. In this report, the term “chemical testing industry” applies broadly 

to any organization that has the capability to use standard laboratory methods to determine the 

effects that a particular chemical may have on human health or the environment. These may 

include contract research organizations (CROs), whose primary line of business is testing for 

chemical toxicity; in-house testing laboratories maintained by chemical companies or others 

 1 EPA. Laboratory Testing of Chemicals for Endocrine Disruption Potential–Analysis of Market Factors, Draft. 

Office of Pollution Prevention and Toxics. July 2, 2009. 2 EPA. Laboratory Industry Capacity To Conduct Health And Environmental Testing Of Nanoscale Materials, 

Office of Pollution Prevention and Toxics. October 6, 2010.
2

(who may also do work for hire); as well as laboratories maintained and operated by academic or 

other institutions. Since the primary data source for this report was exhibitors at ToxExpo, 

however, and these consisted almost exclusively of CROs, the data and discussion largely reflect 

the CRO segment of the testing industry. 

Chapter 2 provides an overview of the major existing chemical initiatives that may generate 

demand for testing, while Chapter 3 provides a discussion of the testing industry’s ability to meet 

this demand. Chapter 4 examines trends and economic factors that may influence the supply and 

demand for chemical testing. The last chapter provides a summary and draws some tentative 

conclusions about the testing industry’s ability to meet potential EPA-generated demand. 
3

2.0 Demand for Laboratory Testing Services

Historically, laboratories have indicated that EPA regulatory and voluntary initiatives related to 

the assessment of industrial chemicals have not generated a significant volume of chemical 

testing demand compared to their work with pharmaceutical and biotechnology products.3

Recent developments, particularly the enactment of Registration, Evaluation, Authorization, and 

Restriction of Chemical (REACH) legislation in the European Union, could cause a spike in 

demand for such testing. This Chapter reviews the major U.S. and European testing initiatives 

with subsections 2.1 through 2.3 describing the specific efforts and potential for overlap of 

testing demands. 

2.1 Environmental Protection Agency Initiatives

2.1.1 High Production Volume (HPV) Challenge Program

In 1998, multiple studies confirmed that significant gaps existed in the data needed to understand 

hazards associated with a large percentage of the high production volume (HPV) chemicals used 

in the United States.4 In that year, EPA worked with stakeholders to launch the HPV Challenge 

Program for chemicals produced or imported into the U.S. in quantities of one million pounds or 

more per year. The Agency asked manufacturers and importers to voluntarily commit to provide 

basic hazard testing data to support EPA’s mission of protecting human health and the 

environment. The hazard data endpoints being requested under the HPV Challenge are the same 

as those specified in the Organisation for Economic Cooperation and Development’s (OECD’s) 

Screening Information Data Set (SIDS) dossiers. The SIDS dossiers cover five main categories of 

data: general information (e.g., use patterns, volume), physical-chemical properties, 

environmental fate and transport, ecotoxity, and toxicity. Appendix A provides the list of SIDS 

tests.

This section reviews the scope and status of the HPV Challenge Program with a focus on 

estimating the potential number of chemicals that may still require testing, and describes any

overlap with similar international programs. 

As of June 2007, companies had committed to EPA to provide test data for over 2,200 HPV 

chemicals. This includes approximately 1,400 “directly” sponsored chemicals as well as 860 

chemicals sponsored indirectly by the International Council of Chemical Associations (ICCA) 

under the OECD’s HPV Chemicals Initiative.5

 3 EPA. Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing Program Initiatives. Office of 

Pollution Prevention and Toxics. August 30, 2004.

By 2009, data for roughly 1,000 of the 

approximately 1,400 directly sponsored chemicals had been entered into EPA’s HPV 

4 EPA defines HPV chemicals as those produced or imported into the U.S. in quantities of 1 million pounds or more 

per year. OECD defines HPV chemicals as chemicals manufactured or imported into an OECD member country in 

quantities greater than 1,000 metric tonnes (approximately 2,200,000 lb) per year. 5 The ICCA sponsored 1,020 chemicals under the OECD HPV Chemicals Initiative, of which 860 are considered 

HPV chemicals under the EPA HPV Challenge.
4

Information System Web database.6 OECD reports that assessments have been completed for 

887 of the 1,020 sponsored HPV chemicals (87 percent).

7 Details on how many of those 

completed assessments that are also on the EPA HVP list were not available.

Based on the number of chemicals that have been sponsored but for which data have not yet been 

submitted, the EPA and OECD/ICCA HPV programs may lead to the need for new testing of 

approximately 500 chemicals.8 The number of outstanding submissions that will require new 

testing, however, is unknown. In analyzing the data collected as of June 2004, for example, EPA 

found that only 10 percent of HPV chemicals required new testing. Instead, most of the data 

needed to satisfy the program needs were pre-existing.9

2.1.2 Orphaned HPVs

On the other hand, the fact that no data 

has been submitted to date on these 500 chemicals may indicate that less existing data is 

available, and a higher percentage may require new testing. Given this, significant uncertainty 

remains concerning how much additional testing will be required for these chemicals.

10

In February 2010, EPA reported that approximately 207 chemicals originally identified as HPV 

chemicals remained unsponsored under the HPV Challenge. EPA can potentially collect basic 

hazard data for these “orphaned” chemicals through regulatory actions such as TSCA Section 4 

Test Rules and TSCA Section 8(a)/8(d) Rules. Section 4 rules require manufacturers to develop 

test data to fill any information gaps while Section 8 rules can be used to require companies to 

submit existing test data already in their possession. Twenty-nine of those 207 orphan chemicals 

have been named in a proposed rule, which will require manufacturers and processors to conduct

testing necessary to complete the SIDS dossier.

11

2.1.3 EPA’s New Chemicals Management Program

The final report on each specific test for each

subject chemical substance is due to EPA 13 months after the effective date of the final rule.

On September 29, 2009, EPA announced a new, comprehensive approach to enhance the 

Agency’s chemicals management program.12 This new approach includes the following 

activities:

 6 Office of Pollution Prevention and Toxics, “HPV Challenge Program,” OPPT Accomplishments Report January 

2007 - January 2009, EPA. April 14, 2009. Available at www.epa.gov/oppt/ar/2007-

2009/managing/hpv_program.htm. 7 Hernandez, Oscar and Louis Scarano. “Proposed Approach for the Inorganics HPV Challenge Program

(IHPV),” Office of Pollution Prevention and Toxics, EPA. December 8, 2008.

8 There are 392 remaining (i.e., 1,400-1,008) directly sponsored chemicals in EPA’s HPV Program and 113 (i.e., 

1,000-887) under the OECD initiative. Note: the OECD number is based on assessments completed rather than data 

submitted, so some testing may have already been completed.

9 Office of Pollution Prevention and Toxics. Status and Future Directions of the High Production Volume Challenge 

Program, 743-R-04-001, November 2004. Available at www.epa.gov/hpv/pubs/general/hpvreport.pdf. 10 This section is based on EPA, “Testing of Certain High Production Volume Chemicals; Third Group of

Chemicals,” Proposed Rules, Federal Register, February 25, 2010. 11 EPA, “Testing of Certain High Production Volume Chemicals; Third Group of Chemicals,” Proposed Rules, 

Federal Register, February 25, 2010. 12 Jackson, Lisa. “Enhancing EPA’s Existing Chemical Management Program,” September 29, 2009. Available at 

www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html.
5

• Development of chemical action plans;

• Development of new regulatory risk management actions;

• Requiring information needed to understand chemical risks; and

• Increasing public access to information about chemicals.

EPA is developing chemical action plans to target EPA’s risk management efforts for certain 

“chemicals of concern.”13 These action plans are based on EPA’s review of available hazard, 

exposure, and use information, and outline the risks each chemical may present. The action plans 

also discuss the specific steps EPA will take to address the risk concerns. An action plan may 

include new regulatory actions under TSCA. EPA has already developed or is developing new 

regulatory risk management actions on a number of chemicals.

As part of the new initiative, EPA has stated plans to develop new actions under TSCA Sections 

4, 5, and 8. Specifically, as discussed in the previous section, EPA announced plans to publish 

test rules under Section 4 of TSCA to generate data on orphaned (unsponsored) HPV Challenge 

chemicals. The Agency is planning similar action for sponsored but unfulfilled HPV Challenge 

chemicals. Additionally, EPA has initiated action to require notification under significant new 

use rules (SNUR) issued under Section 5 of TSCA on additional HPV chemicals. These SNURs 

can potentially lead to more testing as companies who want to engage in a new use of a subject 

chemical must submit notice (and often submit testing data) to the Agency for review prior to 

initiating a new use. At this time, EPA has not announced the number of HPV chemicals that 

may be covered by these additional TSCA Section 4 and Section 5 rulemakings.

EPA is also developing a proposed rule under Section 4 of TSCA to require companies to test 

nanomaterials for health and environmental effects.14 The specific nanomaterials or total number 

of nanomaterials to be addressed under this proposed rule is unknown at this time. As previously 

mentioned, EPA has separately analyzed the availability of laboratory capacity to conduct the 

type of testing expected to be requested under this proposed action.

15

It is not yet certain how many chemicals will require testing under EPA’s comprehensive 

approach to enhance its chemical management program. Additionally, it is uncertain how many

chemicals have outstanding testing commitments under the HPV program. Accordingly, it is 

premature to draw any conclusions about the potential impact of this new chemical management 

approach on the demand for new testing.

2.1.4 Endocrine Disruptor Screening Program

Under the Endocrine Disruptor Screening Program (EDSP), EPA has identified chemicals and 

pesticides (including pesticide inert ingredients) that may have the potential to exhibit endocrine 

disrupting properties. EPA has completed issuing test orders requiring screening for the first 

 13 EPA Announces Actions to Address Chemicals of Concern, News Release, December 30, 2009. Available at 

yosemite.epa.gov/opa/admpress.nsf/0/2852C60DC0F65C688525769C0068B219. 14 EPA. “Control of Nanoscale Materials under the Toxic Substances Control Act.” April 22, 2010. Available at: 

http://www.epa.gov/oppt/nano/. 15 EPA. Laboratory Industry Capacity to Conduct Health and Environmental Testing of Nanoscale Materials. Office 

of Pollution Prevention and Toxics. October 6, 2010.
6

group of 67 pesticides and pesticide inert ingredients to determine their endocrine disruptor 

potential.16 EPA is requiring recipients of these test orders to submit data for 11 screening assays 

within two years of the date of issuance of the order. In addition to generating new data, test 

order recipients also have an option to cite or submit existing data (i.e., other scientifically 

relevant information),

17 along with a rationale that explains how the cited or submitted study 

satisfies the Tier 1 test order in lieu of developing new data. EPA will evaluate such proposals 

and determine whether the information can be used to satisfy part or all of the Tier 1 order and/or 

otherwise inform the Tier 1 determination. 

EPA expects that some test order requirements will be fulfilled by other scientifically relevant 

information; however, EDSP test orders could generate a need for testing in 2010 to 2012. The 

testing generated under the EDSP, particularly related to in vivo assays, could compete with 

other types of chemical testing for laboratory space, employees, and equipment. In a related 

effort, however, EPA found that sufficient capacity is likely to be available to conduct the testing 

required under this program. More details about this can be found in Laboratory Testing of 

Chemicals for Endocrine Disruption Potential–Analysis of Market Factors.

18

2.1.5 Perfluorinated Chemical Testing 

Since the late 1990s, EPA has been reviewing the risks associated with perfluorinated chemicals, 

specifically perfluorooctanoic acid (PFOA) and perfluorooctyl sulfonate (PFOS), after reports 

were published of the substances being found in blood of the general population. Studies have

indicated that PFOA and PFOS are persistent, can cause developmental and other adverse effects 

in laboratory animals, and are bioaccumulative.

The Agency has finalized TSCA Section 4 enforceable consent agreements with industry for 

incineration testing to see whether PFOA breaks down when articles containing PFOA are 

disposed of in municipal incinerators. The Agency has also negotiated Memoranda of 

Understanding to evaluate the potential presence of PFOA and PFOA precursors in air, water, 

soils, sediments, and biota in the vicinity of DuPont and 3M/ Dyneon manufacturing plants.19

 16 EPA. “EPA to Begin Testing Pesticides for Endocrine Disruption,” April 15, 2009.

The agreements and memoranda of understanding studies do not include PFOS since EPA 

instituted a separate phase out of PFOS allowing its use only in limited quantities for exempted 

uses. In 2005, EPA and DuPont reached a settlement requiring DuPont to complete tests on its 

fluorotelomer products, such as polytetrafluoroethylene (PTFE), which may contain trace 

amounts of PFOA and other related perfluorinated chemicals as impurities. Technical challenges 

in developing a method to purify the fluorotelomer products, however, caused EPA to extend the 

17 Other scientifically relevant information may either be functionally equivalent to information obtained from the 

Tier 1 assays (i.e., data from assays that perform the same function as EDSP Tier 1 assays) or may include data that 

provide information on a potential consequence or effect that could be due to effects on the estrogen, androgen or 

thyroid systems. Some other scientifically relevant information may be sufficient to satisfy part or all of the Tier 1 

order and/or otherwise inform the Tier 1 determination.

18 EPA. Laboratory Testing of Chemicals for Endocrine Disruption Potential–Analysis of Market Factors, Draft. 

Office of Pollution Prevention and Toxics. July 2, 2009.

19 EPA, “Frequent Questions,” Perfluorooctanoic Acid (PFOA) and Fluorinated Telomers, March 19, 2009. 

Available at http://www.epa.gov/oppt/pfoa/pubs/faq.html.
7

testing deadline to December 27, 2011.20 EPA has also issued provisional health advisories for 

PFOA and PFOS to protect against potential risk from exposure to these chemicals through 

drinking water.

In 2002 and 2007, EPA issued SNURs under TSCA Section 5 to limit any future manufacture or 

importation of perfluoroalkyl sulfonates (PFAS) and related chemicals specified in the rules. 

These SNURs allowed the continuation of a few specific and limited, highly technical uses of 

these chemicals for which no alternatives were available, and which were characterized by low 

volume, low exposure, and low releases. Any other uses of these chemicals would require prior 

notice to and review by the Agency. EPA also reviews proposed substitutes for PFOA, PFOS,

and other long-chain perfluorinated substances as part of its New Chemicals Program review 

process. If potential risks are determined not to be unreasonable, production or importation of 

these substitutes is generally allowed with a consent order that imposes testing requirements and 

in some cases, exposure and release controls. 21 Many other countries, including those within the 

European Union under the REACH program, are also reviewing test data for proposed 

substitutes.22

During the 2009 ToxExpo, seven CROs thought to have expertise with perfluorinated chemicals 

were asked about their testing work in this area. These labs were identified based on having 

responded positively in 2006 to a question regarding their ability to conduct chemical testing of 

PFOA. Five of the seven laboratory representatives were not aware of any work on 

perfluorinated chemicals conducted by their organization. Without further investigation, it is 

unclear whether the marketing representatives at ToxExpo were simply unfamiliar with the area 

of perfluorinated chemical testing, whether their organization had yet to actually receive a test 

request in this area, or whether it had decided not to pursue or accept such testing work.

One laboratory confirmed it had performed some testing and indicated that perfluorinated 

chemicals were “a little harder to deal with” than more conventional chemicals. A second 

laboratory explained that meaningful analytical data is difficult to obtain without labeling the 

chemical with carbon-13. However, the reaction used to label many of these perfluorinated 

compounds can be quite explosive; thus, it is not common for chemical manufacturers to sell 

carbon-13 labeled perfluorinated products. Without the carbon-13 label, the laboratory felt the 

chemical analyses are less reliable and can take significantly more time to conduct due to the 

extra verification steps necessary. Both laboratories discussing perfluorinated chemicals 

indicated that the amount of testing they were completing on the compounds had been 

decreasing.

 20 Eder, Andrew. “DuPont Gets More Time to Test PFOA,” DelawareOnline. February 10, 2009. Available at 

www.delawareonline.com/article/20090210/NEWS/902100331. 21 Krasnic, Toni. U.S. EPA, “New Chemical Review of Alternatives for PFOA and Related Chemicals in U.S.” 

Presented at Workshop on Managing Perfluorinated Chemicals and Transitioning to Safer Alternatives. February 12, 

2009.

22 United Nations Environmental Programme, “Thought Starter: Elements to Consider When Working Towards 

Stewardship of Perfluorinated Chemicals and Transitioning to Safe Alternatives,” Workshop on Managing 

Perfluorinated Chemicals and Transitioning to Safer Alternatives Geneva, Switzerland. February 12-13, 2009. 
8

2.2 European Chemicals Agency Requirements

In 2007, requirements for the European Union’s REACH legislation entered into effect. REACH 

requires the registration of chemicals and submission of test data to identify risks that chemicals

may pose. Registration is required for chemicals manufactured or imported in quantities of one 

tonne or more per year. Chemicals must be registered before they can be manufactured, 

imported, or otherwise introduced into the European Union market.

For most chemicals already manufactured or imported before REACH entered into force, a 

phase-in was established to allow their continued manufacture or import, provided the chemical 

had been pre-registered prior to December 1, 2008. Phase-in registration deadlines were assigned 

for different volume categories. The registration of the first group of chemicals began in June 

2008 and is scheduled to end in December 2010. 

Table 2-2 summarizes the different testing requirements that apply to each of the REACH 

volume categories. In general, less test data are required for lower production volume chemicals.

For those chemicals in the higher volume tiers (greater than 100 metric tones), registration 

requires data from all tests required for chemicals produced below 100 metric tons, along with 

submission of a test plan for additional data required for that production volume (see Table 2-2). 

This test plan should be based on the results of previous testing analysis (e.g., in vitro studies, 

structure-activity relationship (SAR)).

Table 2-2: REACH Substances and Testing Required

Threshold 

Volume

Metric Tonnes[a]

Estimated 

Number of

Substances[b] Testing Required[c]

Submission 

Deadline[d]

between 1 and 10 20,000

• Physical-chemical properties

• Acute toxicity

• Environmental toxicity and 

biodegradation

May 31, 2018

between 10 and 

100 4,600

Same as above, plus: 

• Additional acute toxicity

• Repeated dose toxicity

• Reproductive toxicity

• Additional environmental toxicity

May 31, 2018

between 100 and 

1,000 2,900

Same as above, plus potentially:

• Additional physical-chemical

• Further repeated dose toxicity

• Long-term aquatic toxicity

• Degradation and e-fate

• Terrestrial toxicity

May 31, 2013

1,000 or greater 2,600

Same as above, plus potentially:

• Additional long term toxicity

• Additional long term aquatic toxicity

• Additional terrestrial toxicity

November 30, 2010

Total 30,100

[a] Manufactured or imported into the European Union on an annual basis.

[b] These values are the estimated number of existing substances that were to be registered under REACH. These 

values do not account for existing substance testing data generated under other initiatives such as the U.S. HPV or 

OECD/ICCA initiatives. Source: ERM Economics, 2004.
9

[c] Source: Foster, Robert. “REACH (Registration and Evaluation),” Presented at SOCMA Corporate Excellence 

Conference. May 16, 2008.

[d] Source: ECHA, Guidance on Registration. November 9, 2009. Available at 

http://guidance.echa.europa.eu/docs/guidance_document/registration_en.pdf.

In February 2009, the European Chemicals Agency (ECHA) reported that 143,000 substances 

are on the pre-registration list23—well above the 31,000 originally estimated.24 ECHA believes, 

however, that this list contains many duplicates as well as substances that are not required to be 

reported under REACH.

The pre-registration period for phase-in substances was 

from June 1 to December 1, 2008. As noted in Table 2-

2, the earliest registration deadline for pre-registered 

phase-in substances is for the highest volume 

substances, and this deadline is November 30, 2010. 

Within this first group are those identified by ECHA as 

“chemicals of concern” including: 1) carcinogenic, 

mutagenic, and reprotoxic substances (CMR); 2) 

persistent, bioaccumulative, and toxic (PBT) 

substances; or 3) very persistent and very 

bioaccumulative (vPvB) substances.

25

25

Table 2-3 shows 

the number of chemicals in each of these categories. 

From a total of 1,400 chemicals of concern, it is expected that industry will phase out the 

production of approximately 500, resulting in approximately 900 that may require further 

testing.

On April 16, 2010, ECHA published a list of 4,415 substances that it expects to be registered by 

a deadline of November 30, 2010.26 These substances are either classified as “chemicals of 

concern,” or meet the highest volume threshold. Sponsors can propose to meet the minimum data 

requirements for each data element in several ways: 1) by providing published, scientifically 

adequate data; 2) by providing previously unpublished, scientifically adequate data; 3) through 

the application of an estimation technique such as SAR models, or “read-across” methods within 

a chemical category; 4) by providing a rationale for not testing; or 5) by proposing new testing, 

using approved non-animal methods where available. 

A 2004 assessment completed on behalf of the United Kingdom’s Department for Environment,

Food, and Rural Affairs (DEFRA) concluded that, for the most part, data generated under the 

EPA and OECD/ICCA HPV initiatives will satisfy the SIDS endpoint data required of chemicals 

in the 1 to 10 and 10 to 100 metric tonne production levels (testing requirements are summarized 

 23 ECHA, “ECHA Publishes An Updated List Of Pre-Registered Substances,” March 27, 2009. Available at

http://echa.europa.eu/doc/press/pr_09_03_list_prereg_substances_20090327.pdf. 24 ERM Economics. New European Chemicals Strategy: UK Partial Regulatory Impact Assessment. United 

Kingdom Department for the Food, Environment, and Rural Affairs. March 2004. Available at 

http://randd.defra.gov.uk/Document.aspx?Document=CB01038_3291_FRP.pdf. 25 ERM Economics, 2004. 26 ECHA. “Downstream Users can check list of intended 2010 registrations,” April 16, 2010. Available at 

http://echa.europa.eu/doc/press/na_10_18_dcg%20_du_20100416.pdf.

Table 2-3: Estimated Number of 

REACH Chemicals of Concern 

Chemical 

Category

Number of 

Chemicals

CMRs 700

PBTs 467

vPvBs 233

Total 1,400

Expected to be 

phased out 500

Total 900
10

in Table 2-2).25 This would suggest that for the estimated 24,600 chemicals in these volume 

categories (see Table 2-2), the REACH requirements would not generate competing demand for 

laboratory testing capacity. It must be noted, however, that the DEFRA study was prepared 

several years prior to REACH coming into effect and may have been somewhat speculative.

After the 2010 deadline, there will be additional registration deadlines in 2013 and 2018 for 

chemicals produced at lower volume thresholds. As part of the registration dossier, submitters 

may propose additional animal testing to eliminate gaps in the data. This proposed testing for 

chemicals imported or produced in volumes greater than 100 metric tonnes may not be carried

out until ECHA has evaluated the test proposals. For these chemicals, it is not expected that 

evaluation of registration documents will be fully complete until between 2013 and 2016,

meaning testing in the short-term may be very limited.27

The 2008 and 2009 REACH Progress Reports provide updates on the number of registration 

dossiers submitted since the entry into force of REACH.28,29

28

In 2008, only 10 complete 

registration dossiers were submitted; however, none of these included a testing proposal. From 

this it can be concluded that none of these 10 registered substances would require additional 

testing beyond anything already submitted in support of the registration dossier.

Table 2-4 summarizes the number and type of completed registration dossiers submitted in 

2009.29 As noted, this report includes a category for “transported intermediates.” REACH 

classifies intermediates as either on-site (limited to being used at the same site where the 

chemical is manufactured or imported) or transported (i.e., shipped to a second site for use under 

strictly controlled conditions). In general, transported intermediates are subject to reduced 

registration requirements (fewer data elements) if they are handled under strictly controlled 

conditions as defined by REACH.

Table 2-4: Number of Complete Registration Dossiers Submitted in 2009

Threshold 

Volume (Metric 

Tonnes)*

Non-Intermediate 

Registrations

Transported Intermediates

Registrations

Total

Non-Phase-In 

Substances

Phase-In 

Substances

Non-Phase-In 

Substances

Phase-In 

Substances

1 - 10 90 12 70 7 179

10 - 100 19 10 81 18 144 100 - 1,000 8 8

1,000 or greater 7 58 7 11 83

Total 124 88 158 36 406

* Manufactured or imported into the European Union on an annual basis.

As shown in Table 2-4, a total of 406 completed registration dossiers were submitted in 2009. 

The 2009 REACH Progress Report also states that the first eight testing proposals were 

submitted to ECHA in 2009. Five of these eight proposals concerned non-phase-in substances. It 

 27 SRU. Toxic Substances and REACH: Selected chapters of the Environmental Report 2008 Volume 3. German 

Advisory Council on the Environment. 2008. 28 ECHA. Evaluation: Progress Report 2008. February 27, 2009. Available at 

http://echa.europa.eu/doc/progress_report_2008.pdf. 29 ECHA. Evaluation under REACH: Progress Report 2009. February 25, 2010. Available at 

http://echa.europa.eu/doc/progress_report_2009.pdf.
11

is uncertain whether additional testing proposals are expected for the other 298 registration 

dossiers submitted in 2009.29

Table 2-5 summarizes this report’s estimates of the number of substances registered in 2009 that 

may require additional testing.30 This table uses the data presented in Table 2-4 and assumes

chemicals produced below the 100 metric tonne threshold will not require additional testing 

since they are subject to less extensive requirements (see Table 2-2). Given this, it is reasonable 

to assume that most of the data requirements for chemicals in these volume categories will be 

met with data submitted as part of the registration dossier.

Table 2-5: Estimated Number of Substances Requiring Additional Testing After 

Registration

Threshold 

Volume (Metric 

Tonnes)*

Non-Intermediates Transported Intermediates

Total

Non-Phase-In 

Substances

Phase-In 

Substances

Non-Phase-In 

Substances

Phase-In 

Substances

1 – 10 0 0 0 0 0

10 – 100 0 0 81 18 115 100 - 1,000 8 8

1,000 or greater 7 58 7 11 83

Total 15 66 88 29 198

* Manufactured or imported into the European Union on an annual basis.

Source: ECHA. Evaluation under REACH: Progress Report 2009.

Industry has suggested that resources will be diverted from voluntary HPV initiatives toward 

REACH compliance.31 Based on the estimates summarized in Table 2-5, however, it does not 

appear that there will be a significant surge in demand for testing in the near term, (i.e., the next 

four years) that will challenge the existing capacity of commercial chemical testing facilities. 

Initial results and expectations are that a significant amount of the test data being requested 

already exists and will be forthcoming to satisfy these demands. 

2.3 Food and Drug Administration Requirements

In a 2004 EPA report,

32 toxicology laboratories reported that testing to meet Food and Drug 

Administration (FDA) requirements represented the largest share of their business base, and that 

business decisions related to physical space, equipment, and human resources were strongly 

linked to FDA testing program requirements.33

 30 This report conservatively assumes none of the registered intermediates are handled under strictly controlled 

conditions as defined by REACH and therefore will be required to submit standard full data packages as determined 

by their production volume category.

This section considers the extent to which FDA31 Chemical Watch Research & Publishing, Chemical Watch: European Business Briefing, March 2009. Available at 

http://chemicalwatch.com/index.cfm?action=briefing.issue. 32 EPA. Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing Program Initiatives. Office of 

Pollution Prevention and Toxics. August 30, 2004.

33 EPA, Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing Program Initiatives. Office of 

Pollution Prevention and Toxics. August 30, 2004.
12

driven testing of pharmaceuticals overlaps with some of the testing being required of EPA for 

chemicals, and provides an outlook on the demand for pharmaceutical testing in these areas. 

Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA requires toxicology 

testing of pharmaceuticals and food additives. Commonly required in vivo tests specified by the 

FDA for human pharmaceuticals include:34

• Toxicokinetics and pharmacokinetics in rodents and/or other species 

• Single-dose studies in rodents, and occasionally dogs and primates 

• Subacute (14-28 day), subchronic (90 day) and/or chronic (90+ day) studies in rodents, 

dogs, and occasionally primates 

• Reproduction segment I––fertility studies in rodents 

• Reproduction segment II––prenatal developmental toxicity in rodents and rabbits 

• Reproduction segment III––postnatal development in rodents 

• Mutagenicity and genotoxicity studies of at least two varieties 

• Carcinogenicity studies in rats and transgenic mice 

• Immunotoxicity in rodents 

• Triggered specialized studies (e.g., phototoxicity and pyrogenicity)

CROs called upon to perform SIDS testing in the areas of general acute toxicity, repeated dose 

toxicity, and reproductive and developmental toxicity could face competing demands for their 

services since these tests require the same or very similar equipment, skills, and laboratory space 

as those required for certain types of FDA testing. During discussions with exhibitors at 

ToxExpo, however, CROs reported that demand from pharmaceutical and biotech companies has 

recently declined, in some cases significantly. For example, one laboratory that has historically 

performed about half its work for the pharmaceutical industry and half for the chemical industry 

reported a major decline in demand from pharmaceutical clients, while demand from the 

chemical sector has remained strong. As a result, this laboratory has shifted staff in the short 

term to industrial chemical toxicology work. 

The ability of CROs to change their service offerings in response to changes in demand is of 

interest because of the potential increase in chemical testing demand driven by EPA, EU, and 

related initiatives. In the case of the laboratory cited above, the shift to chemical testing in the 

face of slackened pharmaceutical demand has been “minimally disruptive.” This CRO 

emphasizes cross-training of employees and uses the same or similar equipment and skill sets in 

both types of testing. Somewhat ironically, this same lab made a shift in the opposite direction 

seven years ago, when it faced a decline in chemical testing resulting from the consolidation that 

was occurring in the chemical and agri-chemical industries. They are now seeing a similar 

consolidation in the pharmaceutical and biotech markets, which has resulted in fewer test 

requests. 

It is important to note that this observation is based on anecdotal evidence from a small number 

of CROs, but it may be indicative of at least some flexibility in the industry to adjust capabilities 

in response to changes in chemical testing demand. Based on discussion with laboratories, EPA 

 34 The Humane Society of the United States and Procter & Gamble, “FDA,” December 6, 2007. Available at: 

www.alttox.org/ttrc/us/regulatory-research-agencies/fda.html.
13

does not believe any significant testing demand will be generated to meet FDA testing 

requirements that will overcome the testing industry’s current underutilization of capacity.
14

3.0 Supply of Testing Services

This section reports on efforts to identify and characterize those laboratories capable of meeting 

the chemical industry’s demand for testing services as outlined in Chapter 2. Since no

comprehensive directory of laboratory capabilities exists that would allow such an identification, 

and a survey to determine these capabilities was outside the scope of this study,35 this section 

relies largely on anecdotal information, as explained below. While not comprehensive, the 

information compiled should still be helpful as EPA seeks to better understand the potential 

number of laboratories with these capabilities and their capacity for conducting the testing.

3.1 Laboratory Capabilities for SIDS

To assist in assessing the number and geographic distribution of CROs capable of conducting the 

types of testing of interest to EPA, Eastern Research Group, Inc. (ERG) attended (on EPA’s 

behalf) the annual meeting and exhibition of the Society of Toxicology. This meeting took place 

in Baltimore, Maryland from March 15-19, 2009. The exhibition part of the meeting, called 

ToxExpo, hosted more than 350 exhibitors from the United States and overseas including 

pharmaceutical companies, chemical manufacturers, and CROs, whose primary line of business 

is toxicity testing on either new pharmaceutical compounds or manufactured chemicals.

36 Many 

of the exhibitors were CROs who annually attend and exhibit at ToxExpo in order to market and 

communicate their capabilities to potential clients. Based on the successful collection of 

comparable information from this event in the past (e.g., to develop the 2004 Lab Capacity 

Report), EPA judged that the 2009 ToxExpo was likely to attract a majority of CROs with 

chemical testing capabilities of interest for the present report.

As described in Chapter 2, one of the primary testing data sets requested by EPA and ECHA is 

the SIDS suite of tests. The primary testing categories are:

• Physical-Chemical Data

• Environmental Fate 

• Aquatic Ecotoxicity 

• Toxicity to Terrestrial Organisms

• General Acute Toxicity

• Repeated Dose Toxicity

• Genetic Toxicity

• Reproductive and Developmental Toxicity

Appendix A lists the specific SIDS tests and OECD test guidelines represented by each main 

category of testing. Besides seeking to characterize CRO capabilities in these areas, EPA also 

sought to identify laboratories with analytical chemistry capabilities (listed in Table 3-1 as 

 35 The Paperwork Reduction Act prohibits federal agencies from making the same information request of more than 

nine entities without approval from the Office of Management and Budget. 36 Society of Toxicology. “SOT 48th Annual Meeting and ToxExpo,” accessed April 24, 2009. Available at 

http://www.toxicology.org/AI/MEET/AM2009/index.asp#.
15

“Analytical Chemistry”) and include this type of testing as part of the SIDS discussion.37 While 

analytical chemistry is not an individual component of SIDS testing, labs often need to perform 

analyses at the end of each SIDS test that require analytical chemistry capabilities.

Prior to the conference, ERG reviewed the catalog of exhibitors and identified those known or 

believed to offer chemical testing services, based on the exhibitor descriptions. At the 

conference, ERG visited the booths of 90 CROs, reviewed marketing literature, and asked 

general questions about each laboratory’s capabilities. Sixty-six firms were determined to have 

capabilities in at least one of the testing categories of interest. Table 3-1 provides a summary of 

the results, while Appendix B provides more specific details on individual laboratories’ 

capabilities. 

Table 3-1. Count of Laboratories with Capabilities for SIDS Testing*

Testing Category

Number of Laboratories

U.S. Non-U.S. Total

Physical-Chemical Data 15 11 26

Environmental Fate 8 7 15

Aquatic Ecotoxicity 7 9 16

Toxicity to Terrestrial Organisms 9 6 15

General Acute Toxicity 32 22 54

Repeated Dose Toxicity 32 19 51

Genetic Toxicity 22 16 38

Reproductive and Developmental Toxicity 19 17 36

Analytical Chemistry 31 16 47

* Based on a subset of 66 laboratories exhibiting at the 2009 ToxExpo. This table does not 

represent total industry capabilities.

From the universe of laboratories exhibiting at ToxExpo, the number of laboratories able to 

conduct SIDS testing ranges from 15 to 54 depending on the testing category. The breadth of 

each laboratory’s capabilities is shown in Table 3-2, which shows the number of laboratories 

with capabilities in one, two, three, and more SIDS testing areas. 

An analysis of the data for individual labs produces a number of observations. It is important to 

emphasize that while these observations are derived from what is probably a representative 

sample of the industry, it is unclear whether these are statistically significant findings that can be 

extrapolated across the entire universe of laboratories. Findings based on the 66 laboratories in 

this sample include:

• The mean number of testing areas (out of nine possible categories) is 4.7.

 37 Most of the SIDS tests are biological ones that require analytical chemistry to perform the analysis at the end of 

the test. Laboratories with analytical chemistry units are more likely to perform the entire test without having to 

subcontract out this aspect of the test. “Analytical Chemistry” does not refer to methods development (the ability of 

a laboratory to develop and validate testing methods); rather, it refers to the ability of a laboratory to perform 

chemical analysis using an existing standardized method.
16

Table 3-2. Number of Testing Capabilities by SIDS Category

Number of Capabilities 

by SIDS Category

Number of Laboratories

U.S. Non-U.S. Total

One 6 2 8

Two 6 2 8

Three 4 0 4

Four 5 3 8

Five 9 5 14

Six 8 3 11

Seven 2 2 4

Eight 0 1 1

Nine 2 6 8

Total 42 24 66

• Laboratories determined to have capabilities in four or fewer of the testing categories are 

unlikely to have capabilities in the areas of environmental fate, aquatic ecotoxicity, or

toxicity to terrestrial organisms. Only laboratories with the broadest range of capabilities 

cover these areas of testing. 

• Of the 15 labs with capabilities in the area of environmental fate, only one has four or 

fewer capabilities suggesting that this type of testing area tends to be offered by 

laboratories that offer a larger suite of SIDS services.

• Of the 28 labs performing testing in four or fewer of the testing categories, 20 of them 

(71 percent) performed general acute toxicity testing, and 18 of them (64 percent) 

performed reproductive and development toxicity testing. 

• Twenty five laboratories represented in Table 3-1 (38 percent) also perform endocrine 

disruptor potential testing. Any laboratory identified as providing this service, also 

performs at least one of the SIDS testing categories. 

Since the focus of ToxExpo is on toxicology-related testing, the small number of exhibitors with 

environmental fate testing capabilities may reflect the lesser importance of this capability to the 

ToxExpo target market. Many exhibitors focus on pharmaceutical work, which may not require 

extensive capabilities in this area. 

The 2004 Lab Capacity Report identified only six laboratories, all headquartered outside the 

U.S., with the capability to offer the full suite of SIDS laboratory testing. In 2009, two U.S.-

headquartered laboratories appear to have full SIDS testing capabilities, which they have 

developed as a result of acquisitions.38

 38 Charles River Laboratories, International, “Charles River History,” accessed April 24, 2009. Available at 

www.criver.com/en-US/AboutUs; Harlan Laboratories, “Corporate Brochure,” accessed April 24, 2009. Available 

at www.harlan.com/about_harlan_laboratories.
17

3.2 Laboratory Capacity to Meet Demand

Exhibitors at ToxExpo were near unanimous in characterizing the testing industry as operating 

“below capacity” at the present time, due to the economic recession. As noted earlier, many 

CROs rely on the pharmaceutical and biotechnology sectors for a substantial part of their 

business. During downturns, customers in these sectors tend to curtail research and development 

and move new products through the pipeline more slowly. Combined with recent consolidations 

in the industry, these conditions have produced a notable decrease in testing demand. CROs with 

a more diversified customer base, or one less reliant on pharmaceuticals and biotechnology, 

reported doing somewhat better or even strengthening their positions, but these were the 

exceptions. 

U.S. CROs are reporting the recession has hit them harder than those in Europe. Some U.S.

CROs used terminology such as “taking it off the chin” or “barely afloat” to describe their 

situation, while for the most part, European CROs have observed a slight or no depression in the 

testing market. While it would be logical to assume the European labs are benefiting from 

REACH, they actually reported having very little REACH-related work in house during the 2009 

discussions. In fact, testing laboratories in Europe, as well as Asia, are generally uncertain about

REACH’s impact on the market. None of the laboratories indicated that they have expanded their 

operations in anticipation of REACH; however, a couple of European laboratories are providing 

consulting services to chemical companies about how to approach the REACH requirements. 

The expected workload to be generated by REACH varied dramatically from laboratory to 

laboratory. A few CROs speculated that chemical companies would complete much of the testing 

using in-house laboratories, form consortia to minimize duplicative efforts, or submit data 

already in their possession. At the other end of the spectrum, one laboratory expressed concern

that industry was procrastinating until the deadline and that demand would suddenly materialize 

as deadlines approached. Some believe or fear that affected companies will delay their testing to 

learn from the experiences of other companies on how to respond to the requirements. This 

particular CRO expressed concern there would be an influx of testing requests in the second half 

of 2010 that would overwhelm European testing capacity, pushing overflow requests to Asia and 

the United States.

3.2.1 Testing Areas with Capacity Limitations

Laboratories, like all businesses, organize and manage their operations according to different 

models. Some emphasize flexibility and expect and train their employees to perform multiple 

types of testing while others remain much more specialized and keep their staff focused on one 

particular area of testing. As a result, it is possible that two given tests may compete for 

resources (i.e., performed by the same personnel) in one laboratory while they would be 

performed by two different specialists in another lab, since each may only be capable of 

performing the test they specialize in. Similarly, capacity concerns can arise through different 

circumstances across different labs. In the examples below, EPA discusses capacity limitations 

and competing tests that seemed to be more typical across laboratories.
18

In general, laboratories noted that in vivo tests would be much harder to scale-up than in vitro

tests should there be a sudden spike in demand. To understand why, it is helpful to discuss how 

laboratories organize these activities. Labs that have both in vivo and in vitro testing capabilities 

indicate they keep these sections physically separate from one another. The in vivo testing is 

done in one area so animal receiving, cage cleaning, and animal testing chambers are located 

close together, to economize on moving and maintaining equipment. The in vitro testing areas

typically require HEPA treated air systems for hood air, along with areas dedicated to media 

preparation. Many in vitro tests, which typically require media preparation, exposure and dosing, 

incubation, and cell counting or evaluation, include many steps that can be completed with 

automated systems, and are usually completed in a matter of minutes to a couple of hours. To

meet an increase in demand for such testing, a lab can initially increase the number of hours the 

machines are operating. In vivo tests, on the other hand, tend to take up more physical space (as 

many of them are performed in cages or tanks) and are performed for a longer duration. Many 

tests last from 28 days up to several months. In addition, some tests can potentially require very 

specific expertise. For example, the SIDS guidelines require the following genetic toxicity tests 

be conducted:

• Gene mutation in prokaryotic cells (OECD guideline 471);

• Chromosomal aberration (OECD guideline 473); and

• Micronucleus test or metaphase analysis of bone marrow cells (OECD guidelines 474 and 

475)

While these tests are all within the same field of toxicology, they are not considered to compete 

among one another for resources. One CRO mentioned that the demand for each of these three 

test types garners enough business to support individual groups to perform the tests separately. 

Another laboratory added that the skills needed and equipment used to conduct the tests has little 

overlap with other tests performed in the lab, resulting in very little competition for resources 

with other tests within the lab.39

When asked their opinion about areas where constraints could arise if SIDS testing demands 

were to increase very significantly, laboratory representatives at ToxExpo mentioned some 

specific testing areas, discussed below.

Inhalation

Inhalation testing was characterized by several CROs as particularly difficult to scale up. 

Inhalation testing requires personnel with specialized training and unique equipment. Two CROs 

noted that it is very difficult to control the airflow on the equipment to ensure proper testing 

conditions, and finding specialists with training suitable to operate the equipment is very 

difficult. As a result, very few employees at these laboratories have the necessary training to 

perform this test. Additionally, a laboratory interested in expanding capacity in this area would 

need to make significant capital investment in equipment and have adequate space to house it. 

Another CRO indicated that in addition to space, equipment, and personnel issues, it would be 

necessary to expand the analytical chemistry unit in unison with expanded inhalation capabilities 

 39 Personal communication with Jian Song, Director of Research, Sitek Research Laboratories. March 15, 2009.
19

in order to analyze all the results.40 Inhalation testing was also noted as a potential bottleneck in 

the 2004 Lab Capacity Report for all the reasons listed above. Additionally in 2004, an expert 

mentioned that few pharmaceutical companies request the tests, and that the test protocols for the 

pharmaceutical and industrial chemicals differ.

41

Biodegradation

Biodegradation was identified as a test with potential capacity limitations. Normally, these tests 

last 28 days, although under certain circumstances they can be shorter. One laboratory noted that 

long test durations can tie up laboratory space and equipment for prolonged periods of time, 

similar to many in vivo toxicity tests. Additionally, the equipment used in biodegradation testing 

is expensive; thus, scaling up would involve significant purchasing decisions. The CRO also 

mentioned that the level of expertise needed in order to perform this test is higher than the 

majority of the other tests they performed. From conversations with these laboratories, EPA

concludes that the hierarchy of impediments to expansion is 1) availability of adequate space, 2) 

equipping such space with expensive equipment, 3) the need for skilled staff, and 4) the length of 

study. Purchasing or leasing more space is a very large, and sometimes prohibitive, capital 

expenditure, and purchasing and setting up expensive equipment also represents a large capital 

cost. The need for additional staff can be partially circumvented in the short term by longer hours

(and possibly shifting staff when their expertise allows), but is still a major capacity limitation.

Reproductive Studies

One laboratory suggested that higher demand for either the first or second generation 

reproductive toxicity studies could compete for resources with each other within a lab. These 

tests use similar laboratory space, much of the same equipment, and compete for the same staff.

Capacity Limitations Conclusions

As seen in the above examples, limited space and long test protocols attribute to capacity 

limitations in toxicology laboratories; however, they are never the sole cause. These issues in 

combination with the need for specialized or expensive equipment or difficult protocols that 

require specialized staff are the primary factors contributing to capacity constraints within a 

laboratory.

Potential for Market Expansion

Laboratories in general report that they rarely hire staff or otherwise “gear up” in anticipation of 

an increase in testing demand. Rather, they wait for demand to materialize in the form of actual 

contracts. If they find themselves short on capacity, they may push back on deliverable dates or 

reschedule work that has lower priority. Some may even offer incentives, such as discounts, to 

entice existing customers to delay scheduled testing. Several CROs exhibiting at ToxExpo 

 40 The CRO mentioned that expanding many types of testing (not just inhalation testing) could potentially lead to the 

need to expand an analytical testing unit.

41 EPA, Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing Program Initiatives. Office of 

Pollution Prevention and Toxics. August 30, 2004.
20

indicated they may accumulate several months’ worth of work in backlog before hiring, to avoid 

layoffs at a later date if the demand increase turns out to be short lived. 

The depressed and volatile state of the current economy has contributed to a more cautious hiring 

environment, according to exhibitors at ToxExpo. These statements echo those heard during the 

stronger economic times of 2004 when EPA queried laboratories about their capacity in 

preparation for the HPV Challenge and REACH.42 While laboratories remarked on their ability 

to quickly move into new areas of testing or expand current areas, they also noted that this 

shifting involves incremental costs and they would proceed cautiously. Many laboratories noted 

the importance of “long-term contracts” or “sustained demand for tests with the likelihood for 

continued demand,” as stable funding is needed to allow for expansion into new areas of testing 

or to increase their capacity within a given area of testing. Laboratories uniformly stated that the 

“promise of demand” alone would not lead them to increase capacity or expand into new areas.

Many ToxExpo exhibitors mentioned that existing data and SAR-based approaches were being 

used to meet a substantial share of the HPV Challenge requirements, and this resulted in 

substantially less new business for the chemical testing industry than was anticipated. 

Laboratories in general are cautious about new initiatives generating demand for their services. 

For programs like HPV, many feel that much of the chemical data already exists and the amount 

of new testing demand created will be minimal. One lasting impact of the testing industry’s 

experience with HPV Challenge may be a reluctance to expand laboratory capacity to 

accommodate similar types of initiatives (e.g., EDSP). A few of the CROs explained that the 

condition of the economy combined with the past disappointment has led them to adopt a firm

“wait and see” approach to any demand increase associated with new testing initiatives.

Assessments on REACH’s Impact

Like EPA, the European Union and stakeholders have expressed interest in the availability of 

laboratory capacity to meet the potential demand generated by REACH. In 2003, the European 

Union Commissioners were reporting that they expected European testing facilities to be able to 

provide only 25 to 30 percent of the testing capacity required for REACH.43 In a 2004 survey, 

Manfred Fleischer of the Social Science Research Center in Germany contacted European 

laboratories to assess their capacity to complete REACH tests.44 Fleischer identified 16 test 

categories (shown in Table 3-3) as having the lowest capacity. These were the tests that the 

author felt could create bottlenecks to industry efforts to comply with REACH, assuming that a 

large number of substances require new testing.45

As Fleischer points out, there are many tests (Table 3-3) that have a total annual capacity of less 

than 30 laboratories across all European Union labs in the study. The vast majority of these tests 

 42 EPA, Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing Program Initiatives. Office of 

Pollution Prevention and Toxics. August 30, 2004.

43 EPA, Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing Program Initiatives. Office of 

Pollution Prevention and Toxics. August 30, 2004.

44 Fleischer, Manfred. “Testing Costs and Testing Capacity According to REACH Requirements—Results of a 

Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland,” Journal of Business 

Chemistry, 4(3): 96-114. September 2007. 45 Note: This analysis is based on the REACH proposal of 2003. EPA did not determine if some of these tests were 

dropped from the final regulation and/or how many chemicals would require these tests.
21

are only required for chemicals with annual import and production volumes of over 100 metric 

tonnes because they fall under the general categories of long term aquatic toxicity, long term 

terrestrial toxicity, and degradation and environmental fate (many repeated dose tests also fall 

under this category). While many of these types of tests may compete for capacity with general 

SIDS testing (inhalation studies, two-generation reproduction toxicity studies, and repeated dose 

toxicity, for example), laboratories have encountered limited demand for REACH tests because 

so much of the test data is already available. Additionally, as discussed in Section 2, there is little 

evidence to suggest that extensive REACH testing will be generated in the upcoming few years 

that will cause further capacity issues for these “bottleneck” tests that Fleischer identifies. 

Finally, Fleischer’s study was not comprehensive in identifying all chemical testing laboratories 

in the European Union, so there is likely additional capacity available above and beyond what is 

presented in Table 3-3.

Table 3-3. REACH Test Categories with the Lowest Annual Average Capacity among

European Laboratories

Test Category

No. of labs

performing 

testing

Total avg. 

capacity/year 

in EU

Long-term toxicity testing on soil invertebrates 2 6

Long-term or reproductive toxicity to birds 3 9

Developmental toxicity study (rabbits), oral gavage 3 12

Sediment simulation testing 6 12

Long-term toxicity testing on plants 2 12

Long-term toxicity testing on earthworms 7 16

Bioconcentration in (one) aquatic species, preferably fish 8 19

Effects on soil micro-organisms 7 19

Short-term repeated dose toxicity: 28 days, inhalation (rats) 8 21

Long-term repeated dose toxicity study (longer than 12 month) 10 21

Short-term toxicity testing on plants 6 25

In vitro cytogenicity study in mammalian cells (micronucleus test) 3 28

Two-generation reproduction toxicity study, oral gavage 11 28

Carcinogenicity study (rats) 11 29

Soil simulation testing (for substances adsorbing to soil) 7 29

Long-term toxicity testing on sediment organisms 6 30

Source: Fleischer, 2007.
22

4.0 Trends and Factors Impacting the Testing Industry

This section discusses a number of additional trends or factors that are currently impacting the 

testing industry, or could affect the industry in the near future. Many of these issues are linked to 

the overall weakness in the economy, which is leading to reduced demand for testing or the 

shifting of activity to lower cost centers.

4.1 Emerging Markets

In a time when pharmaceutical, biotech, and chemical testing firms are looking to tighten their 

spending, shifting testing to laboratories in China or other low-cost centers is being described as 

a very attractive option. One company exhibiting at ToxExpo, which operates laboratories in 

both the United States and China, explained that companies requiring toxicology testing are 

starting to see the use of these emerging markets as a “no brainer.” Companies contracting with 

CROs are exhibiting less resistance towards using Chinese laboratories, as the professional 

standards and quality of the work done in these labs has improved. Many Chinese-based testing 

facilities, for example, are employing Ph.D staff educated at the same U.S. schools as U.S.-based 

laboratories. Because the pay scale in China is lower, Chinese labor costs can be considerably 

less compared to laboratories in developed countries. One laboratory familiar with Chinese 

operations estimated that, due to these labor cost differentials, the overall cost of testing in China 

is 35 to 40 percent below that in the United States. Another lab representative estimated it to be 

closer to 50 percent lower. Still another testing firm, with operations in the United States and one 

other international location, is exploring development of a new facility in China to “take 

advantage of the new trend to outsource” to developing countries. Although China was most 

often mentioned as a new and emerging source of chemical testing service, several laboratories 

also identified India as an emerging market provider of chemical testing services.

Despite these cost advantages, concerns remain about the standards in developing countries. For 

example, China’s reputation in the testing area has been somewhat stigmatized by the country’s 

export of toys containing lead and tainted pet food in 2007. Some U.S. laboratories report their 

customers being more comfortable dealing with a laboratory with a U.S. or European corporate 

headquarters. Two companies indicated they plan to or are currently maintaining their corporate 

headquarters in the United States, while moving some testing capabilities to China. This allows 

them to capitalize on U.S. marketing opportunities while accessing the less expensive Chinese 

work force.

Several CROs stated that “loyalty” and “reliability” help them maintain a constant level of 

demand. If a company is not comfortable with the ability of a CRO to conduct a test, that 

company would either be risking their reputation by relying on these results or would have to 

confirm those results by hiring another CRO. Strong personal and long standing business 

relationships build trust, and this can help discourage companies requiring testing to change 

CROs. This effect partially offsets the trend of utilizing cheaper CROs in emerging markets.
23

4.2 Animal Welfare Issues and Activism

During the development of the European Union’s REACH legislation, concerns about animal 

welfare and the need to develop alternative testing methodologies has been a frequent topic. At 

ToxExpo, one European laboratory noted that government research and development funding for 

in vitro tests in the European Union has increased in the past couple of years while funding 

designated for in vivo tests, which require animals, has fallen dramatically. The representative 

felt that this resulted from animal rights groups putting pressure on the government. This CRO 

itself has not been subject to any direct pressure, but others have.

46

The European Union has made several amendments to its Cosmetics Directive (Council 

Directive 76/768/EEC) to phase out animal testing of beauty products and toiletries. The 

amendments ban animal tests for skin irritancy, sensitivity to light, corrosivity, absorption 

through the skin, genetic toxicity, eye irritancy, and acute toxicity.47 Non-animal alternatives 

(primarily in vitro tests) to four of these tests have been validated and approved by the European 

Union, while the other three are in advanced stages of review. A deadline of March 2013 

establishes a ban on several additional tests including repeated-dose toxicity, reproductive 

toxicity, and toxicokinetics. The cosmetics industry feels it is in a difficult position since existing 

data may not meet the requirements of REACH and alternative tests have not been approved.48

Both REACH and EPA encourage the development of consortia to avoid duplication of 

toxicological studies. Under REACH, all manufacturers and importers who have pre-registered 

the same substance become participants in a Substance Information Exchange Forum (SIEF), 

along with any downstream users or third parties who also pre-register the same substance. The 

participants of the SIEF exchange information and identify data gaps and needs for further 

studies (if any) and arrange for them to be conducted. The development of consortia should 

minimize the amount of animal testing that needs to be performed. The move away from animal 

testing and toward in vitro testing should increase overall laboratory testing capacity because, as 

many CROs pointed out, it is typically much easier to scale up in vitro testing.

4.3 Value of the Dollar

Chemical testing is a global market, in which a range of international clients seek the services of 

a global array of testing laboratories. Companies are typically willing to test overseas if 

international CROs meet appropriate standards since test data is often acceptable across 

companies; however, the value of the dollar relative to other countries’ currency could 

potentially impact the international demand for chemical testing.

When the dollar devalues against the euro, the testing prices of European laboratories become 

more expensive relative to U.S. laboratories. Historically a weaker dollar usually means that U.S. 

 46 Sidique, Haroon, “Animal rights activists guilty of blackmailing research lab suppliers,” The Guardian, December 

23, 2008. Available at www.guardian.co.uk/uk/2008/dec/23/animal-rights-activists-blackmail-guilty. 47 European Commission. “Cosmetics Directive,” Available at 

http://ec.europa.eu/enterprise/sectors/cosmetics/documents/directive/. 48 Pitman, Simon. “REACH Legislation Spell Catch 22 Over Animal Testing,” Cosmetics Design-Europe.com, 

January 20, 2009. Available at www.cosmeticsdesign-europe.com/Formulation-Science/REACH-legislation-spellscatch-22-over-animal-testing.
24

CROs observe more business from Europe. While the dollar has been weak against the euro in 

recent years, CROs exhibiting at ToxExpo did not report a parallel increase in demand for testing 

services at U.S. CROs. It is likely that overall weakness of the economic situation and the related 

decrease in demand for testing services overall is negating any effects related to the value of the 

dollar.

4.4 Economic Uncertainty

With the economy being generally depressed and the future uncertain, companies tend to be very 

conservative with their spending. A few CROs noted a recent trend for biotech and 

pharmaceutical companies (from which they receive most of their testing requests) to lay off inhouse employees in an effort to cut costs. Simultaneously, they are attempting to offset that loss 

in productivity by outsourcing a larger percentage of their work to more automated and cost 

efficient CROs. The net outcome of this phenomenon is unclear since pharmaceutical companies 

and biotech companies are producing fewer drugs and chemicals for testing, yet, they are asking 

CROs to perform more of the associated tests on the drugs and chemicals they are producing.

Testing laboratories, even ones fortunate enough to see growth in this economic recession, have 

been very cautious with their spending as well. Companies noted that they were far from their 

testing capacity so were not looking to hire; however, many companies noted that hypothetically, 

even if they were close to capacity at this time, they would be very hesitant to hire unless they

experience sustained periods of high demand for testing requests. One company that had done 

quite well through the recession noted that they did hire a new employee, but they were very 

cautious because of the economy, and only made the offer after it became clearer that this 

demand would be sustained over a long period.

While CROs have shown a commitment to be flexible to add testing capability for their long 

standing clients or clients with long term contracts, it seems that there will be a strong hesitation 

to expand their total capacity especially during this time of economic uncertainty, without the 

assurance of additional long-term contracts. This means that relative to periods of greater 

economic stability, there would potentially be longer backlog periods before companies are 

willing to take the risk to hire new employees in order to accommodate testing demand.
25

5.0 Conclusions

This report was intended to provide a snapshot of the chemical testing industry and specifically 

those laboratories likely to support any near-term, EPA-generated testing on existing chemicals. 

Although part of this task involved efforts to identify specific laboratories that conduct SIDS 

testing, readers are cautioned that this report is based largely on information from only a subset 

of laboratories (i.e., exhibitors at ToxExpo). It was beyond the scope of work for this report to 

conduct a comprehensive survey of all laboratories that may support EPA-driven testing. 

Nevertheless, the results of this work indicate that sufficient capacity is likely available to 

complete expected testing needs for the next five years, given the fact that laboratories are 

currently working well under capacity and the expected volume of new testing may be limited. 

The one possible caveat is that implementation of the European Union’s REACH legislation 

could still create a spike in testing demand. The fact that laboratories have still not seen an influx 

in testing as the first registration deadline approaches, however, may indicate that manufacturers 

and importers have existing data ready to submit, plan to use alternative methods (e.g., SAR) to 

meet the data requirements, or the number of chemicals in the largest import and production 

volume categories that need to be tested is limited. This appears to be the case for a vast majority 

of chemicals in question. If this holds true, it should ultimately limit the amount of actual “new” 

chemical testing that needs to be done. Once again, however, it should be noted that these 

conclusions are preliminary and are based on limited data submitted to date, supported by 

consistent but anecdotal feedback from the commercial testing industry. In addition, it remains to 

be seen how much of the existing data submitted will ultimately be accepted by regulators. If the 

rejection rate turns out to be non-trivial, there is a possibility a large volume of new testing 

demand may still be triggered. Given the extended deadlines for submitting the data and the 

additional time needed to evaluate the submissions, any surge in testing demand is not expected 

in the short term (i.e., any REACH generated testing demand will likely arise later in the 

decade). By this time, the industry may have a better sense of the level of demand for new 

testing, and will have the time to adjust to it.

The testing industry in general is well under capacity and feels confident that it would be able to 

adjust to any potential increase in demand over a reasonable time frame. Such an expansion 

would only be initiated, however, once a backlog of test requests has been sustained for several 

months and is anticipated to continue over a long period of time. Due to their historical reliance 

on pharmaceutical and biotechnology client testing, few U.S. laboratories would engage in 

speculative expansion in anticipation of increased future testing driven by EPA or European 

chemical testing initiatives. Some of this reluctance may be influenced by past experience 

waiting for EPA-driven testing demand that never materialized. 

China, and to a lesser extent India, are emerging as serious potential competitors to what has 

historically been a largely U.S. and European controlled market. While there are still barriers to 

overcome, the capabilities of Chinese and Indian CROs are quickly approaching those of 

established laboratories in the United States and Europe. With labor costs representing a 

significant proportion of testing costs, China and India can offer similar capabilities at a much 

reduced cost. Manufacturer’s willingness to move business to these overseas providers will 

depend on China and India’s ability to demonstrate credibility and quality, and for the results of 

work done in their facilities to be accepted by industry stakeholders, including regulatory bodies.
A-1

Appendix A: SIDS Tests and Corresponding Guidelines

Table A-1 indicates the specific SIDS data points included in each general category.

Table A-1. Data Requirements and Test Guideline for SIDS

Test Name OECD Guideline

Physical-Chemical Data

Melting Point 102

Boiling Point 103

Density (relative density) 109

Vapor Pressure 104

Partition Coefficient (n-Octanol/water) 107, 117

Water Solubility 105

pH and pKa Value 112

Oxidation-Reduction Potential

Adsorption/Desorption to Soil 106

Environmental Fate And Pathways

Photodegradation 113

Stability in Water (Hydrolysis) 111

Monitoring Data (Environment)

Transport/Distribution OECD Environment

Monograph No.27

Biodegradation 301A-301F

Ecotoxicity 

Acute/Prolonged Toxicity to Fish 203

Acute Toxicity to Aquatic Invertebrates (Daphnia) 202-Part 1

Toxicity to Aquatic Plants e.g. Algae 201

Chronic Toxicity to Aquatic Invertebrates (Daphnia) 202-Part 2

Toxicity to Terrestrial Organisms 205-208

- Avian Dietary Toxicity Test 205

- Avian Reproduction Test 206

- Earthworms Acute Toxicity Test 207

- Terrestrial Plants, Growth Test 208

Health Effects

Acute Toxicity 402-403, 420

- Acute Dermal Toxicity 402

- Acute Inhalation Toxicity 403

- Acute Oral Toxicity 420

Repeated Dose Toxicity Tests 407, 410, 412, 422

- Repeated Dose 28-Day Oral Toxicity Study in Rodents 407

- Repeated Dose Dermal Toxicity 410

- Repeated Dose Inhalation Toxicity 412

- Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test

422

Gene Mutation in Prokaryotic Cells (bacterial) 471

Chromosomal Aberration (in vitro) 473

Micronucleus Test or Metaphase Analysis of Bone

Marrow Cells (in vivo)

474, 475

Reproduction/Developmental Toxicity Screening Test 421, 422

Developmental Study 414-416

- Pre-natal Developmental Toxicity Study 414

- One Generation Reproductions Toxicity Study 415

- Two Generation Reproduction Toxicity Study 416

Sources: U.S. EPA. Guidance for Meeting the SIDS Requirements, 1998, accessed February 24, 2009. Available at 

http://www.epa.gov/hpv/pubs/general/sidsappb.htm. Organisation for Economic Co-Operation and Development. 

ANNEX 1: OECD Test Guidelines for Studies Included in the SIDS. Accessed February 25, 2009. Available at 

http://www.oecd.org/document/23/0,2340,en_2649_34379_1948503_1_1_1_1,00.html.
B-1

Appendix B: Laboratories with SIDS Testing Capabilities

The information provided in this Appendix is based on material collected from exhibitors during 

the ToxExpo trade show, held in Baltimore, Maryland in March 2009. The table represents 

neither an industry directory nor a statistical sample of the entire chemical testing industry. 

Table B-1. Laboratories with Expertise with SIDS Testing Capabilities

Lab Name

Corporate

Headquarters

Location

Physical-Chemical DataEnvironmental FateAquatic EcotoxicityToxicity to Terrestrial OrganismsGeneral Acute ToxicityRepeated Dose ToxicityReproductive and Development ToxicityGenetic ToxicityAnalytical Chemistry

ABC Laboratories USA X X X X X

Advinus Therapeutics Pvt. Ltd. India X X X X X X X X X

American Preclinical Services USA X X

Apredica USA X X X X X

Aurigon Life Science GmbH Germany X X X X X X X

Avogadro USA X X

BASi USA X X X X X X

Battelle USA X X X X X

Bio Test s.r.o.

Czech 

Republic X X

BioAgri Pharma Brazil X X X X X X X X X

BioDuro USA X X X X X X

Biological Testing Center USA X X

BioReliance USA X X X X

BioTox Sciences USA X X X X

Calvert Labs USA X X X X

Cantest Canada X X X X X

Ceetox USA X X X

Charles River Labs USA X X X X X X X X X

CIT France X X X X X X

Clintox Bioservices India X X X X X

CXR Sciences Scotland X X

Development Center for 

Biotechnology (DCB) Taiwan X X X X

Eurofins/Product Safety 

Laboratories USA

X X X X X X

Fraunhofer Institute of Toxicology Germany X X X X X X X X X

Frontier Bio Sciences, Inc. USA X X X X X

Hamner (CIIT Research) USA X X X X

Harlan Labs USA X X X X X X X X X
B-2

Lab Name

Corporate

Headquarters

Location

Physical-Chemical DataEnvironmental FateAquatic EcotoxicityToxicity to Terrestrial OrganismsGeneral Acute ToxicityRepeated Dose ToxicityReproductive and Development ToxicityGenetic ToxicityAnalytical Chemistry

HistoTox Labs, Inc. USA X X X

Huntingdon Life Sciences England X X X X X X X X X

IDEXX Laboratories USA X

IITRI Research Institute USA X X X X X

INA Research Inc. Japan X X X X X X

Inhalation Sciences Sweden X

Integrated Laboratory Systems, 

Inc. (ILS) USA X X X X

ITR Laboratories Canada, Inc. Canada X X X X X

JRF International UK X X X X X X X X X

Korea Environment & 

Merchandise Testing Institute Korea X X X X X X X

Korea Institute of Toxicology (KIT) Korea X X X X X X

LAB Research Ltd. Hungary X X X X X X X X

MB Research Labs USA X X

MicroConstants USA X

Midwest Bio Research USA X

NOTOX

The 

Netherlands X X X X X X X X X

Pacific BioLabs USA X X

Phoenix Bio Japan X

ReachBio LLC USA X X

Ricerca Biosciences USA X X X X X

Sequani UK X X X X X

Singulex, Inc. USA X X X

Sitek Research Laboratories USA X

Smithers Viscient USA X X X X X X

SNBL USA USA X X X X X X

Southern Research Institute USA X X X X X X

Spring Valley Laboratories, Inc. USA X X X

SRI International USA X X X X X X

Stillmeadow Inc. USA X X X X X X X

Sugi Institute of Biological Science 

Co., LTD. Japan

X X X X

Summit PLC UK X X X X

Toxikon USA X X X X X
B-3

Lab Name

Corporate

Headquarters

Location

Physical-Chemical DataEnvironmental FateAquatic EcotoxicityToxicity to Terrestrial OrganismsGeneral Acute ToxicityRepeated Dose ToxicityReproductive and Development ToxicityGenetic ToxicityAnalytical Chemistry

University of Illinois at Chicago 

(Toxicology Research Lab) USA

X X X X X X X

Veritox USA X

Vivo Bio Tech Ltd. India X X X X X

WIL Research Labs, Inc. USA X X X X X

Wildlife International Ltd. USA X X X X X

WuXi AppTech USA X X X X X X

XenoBiotic Laboratories, Inc. USA X