Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35909 

TABLE II—53 NOCS RECEIVED FROM 3/11/13 TO 4/19/13—Continued 

Case No. Received date 

Commencement notice 

end date 

Chemical 

P–11–0550 ..... 3/14/2013 1/15/2013 (G) N-coco alkyltrimethylene0-, polymers with bisphenol A, epichlorohydrin and amodified aliphatic amine. 

P–11–0551 ..... 3/14/2013 1/15/2013 (G) N-coco alkyltrimethylenedi-, polymer with bisphenol A, epichlorohydrin and modified aliphatic amine. 

P–11–0653 ..... 4/3/2013 3/26/2013 (G) Perfluoroalkylethyl methacrylate copolymer. 

P–12–0031 ..... 4/12/2013 3/27/2013 (G) Modified fluorinated acrylate. 

P–12–0042 ..... 3/21/2013 1/24/2013 (G) Polyurethane aqueous dispersion. 

P–12–0080 ..... 4/12/2013 4/8/2013 (G) Fluoroethylene-vinylether copolymer. 

P–12–0117 ..... 4/3/2013 3/21/2013 (G) Substituted pyridinium salt. 

P–12–0145 ..... 4/8/2013 12/18/2012 (G) Styrene acryl copolymer. 

P–12–0256 ..... 4/9/2013 4/6/2013 (G) Dialkyldithiophosphate salt. 

P–12–0380 ..... 4/17/2013 3/21/2013 (G) Monoazo compound. 

P–12–0411 ..... 4/9/2013 3/21/2013 (G) Alkenedioic acid dialkyl ester, reaction products with diamine alkenoic acid alkyl esters.

P–12–0440 ..... 3/13/2013 2/28/2013 (G) Phenol capped urethane prepolymer. 

P–12–0461 ..... 3/12/2013 2/22/2013 (S) Hexandioic acid, polymer wih 1,3-diethyl propanediote, oxybis[propanol] and 1,2- 

propanediol, mono[2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl] ester, 3-oxobutanoate. 

P–12–0474 ..... 4/11/2013 4/10/2013 (G) Ultra violet curable acrylate. 

P–12–0484 ..... 3/27/2013 3/8/2013 (G) Polyester polyol based upon glycerin. 

P–12–0530 ..... 4/12/2013 3/18/2013 (G) Amine acetate. 

P–12–0545 ..... 4/9/2013 3/11/2013 (G) Aromatic amido-amine-modified aliphatic hydrocarbon resin. 

P–12–0546 ..... 4/9/2013 3/11/2013 (G) Aromatic amido-amine-modified aliphatic hydrocarbon resin. 

P–12–0551 ..... 4/9/2013 4/3/2013 (G) Aromatic hydrocarbon mixture. 

P–12–0584 ..... 3/20/2013 3/15/2013 (G) Alkyl phosphonate. 

P–13–0013 ..... 4/12/2013 3/26/2013 (G) Polyurethane polymer. 

P–13–0031 ..... 3/26/2013 3/20/2013 (G) Isocyanate terminated polyester/polyether/mdi polymer. 

P–13–0032 ..... 3/19/2013 3/18/2013 (G) Alkenoic acid, ester with alkylpolyol, polymer with disubsituted alkane. 

P–13–0039 ..... 4/2/2013 3/25/2013 (S) D-glycopyranose, oligomeric, C10-16-alkyl decyl octyl glycosides, 2-hydroxy-3- 

(trimethylammonio) propyl ethers, chlorides, polymers with 1,3-dichloro-2-propanol. 

P–13–0094 ..... 3/25/2013 2/21/2013 (G) Acrylic ester functionalized polyether polymer. 

P–13–0108 ..... 3/20/2013 2/25/2013 (S) Bromine, manufacturer of, by-products from, distant residues. 

P–13–0109 ..... 4/15/2013 3/28/2013 (S) Alkanes, C24-28, chloro. 

P–13–0119 ..... 4/4/2013 3/22/2013 (S) D-glucitol, 1,3:2,4-bis-o-[(4-ethylphenyl)methylene]- 

P–13–0121 ..... 3/20/2013 2/20/2013 (G) Substituted polymeric aromatic amine azo colorant. 

P–13–0137 ..... 3/20/2013 3/4/2013 (S) Butanedioic acid, 2-(2-octen-1-yl)- 

P–13–0170 ..... 3/27/2013 3/19/2013 (G) Phosphoric acid, mixed esters. 

P–13–0174 ..... 4/2/2013 3/24/2013 (G) Substituted carbomoncycles, polymer with alkyldiol. 

P–13–0177 ..... 3/28/2013 3/20/2013 (G) Polyxiloxane acrylic resin. 

P–13–0178 ..... 4/8/2013 3/31/2013 (S) Cyclopentanol, 2-methyl-5-(1-methylethyl)-, 1-propanoate. 

P–13–0179 ..... 4/16/2013 3/26/2013 (G) Alkyl-substituted thiophosphoric acid triamide. 

P–13–0194 ..... 4/11/2013 4/9/2013 (G) Silylated polyazamide. 

P–13–0222 ..... 4/16/2013 4/15/2013 (G) Synthetic crude oil. 

If you are interested in information 

that is not included in these tables, you 

may contact EPA as described in Unit II. 

to access additional non-CBI 

information that may be available. 

List of Subjects 

Environmental protection, Chemicals, 

Hazardous substances, Imports, Notice 

of commencement, Premanufacturer, 

Reporting and recordkeeping 

requirements, Test marketing 

exemptions. 

Dated: June 3, 2013. 

Chandler Sirmons, 

Acting Director, Information Management 

Division, Office of Pollution Prevention and 

Toxics. 

[FR Doc. 2013–14196 Filed 6–13–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2007–1080; FRL–9375–7] 

Endocrine Disruptor Screening 

Program; Final Policies and 

Procedures for Screening Safe 

Drinking Water Act Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This document describes 

EPA’s final policies and procedures for 

requiring Tier 1 screening under the 

Endocrine Disruptor Screening Program 

(EDSP) of chemicals for which EPA may 

issue EDSP test orders pursuant to 

section 1457 of the Safe Drinking Water 

Act (SDWA) and section 408(p) of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). Section 408(p) of the FFDCA 

directed EPA to develop a chemical 

screening program using appropriate 

validated test systems and other 

scientifically relevant information 

(OSRI) to determine whether certain 

chemicals may have hormonal effects. 

These final policies and procedures 

supplement the EDSP policies and 

procedures that were published in the 

Federal Register on April 15, 2009. 

FOR FURTHER INFORMATION CONTACT:

For technical information contact: 

Mike Mattheisen, Chemical Information 

and Testing Branch (7405M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(202) 564–3077; email address: 

mattheisen.mike@epa.gov or Pat West, 

Office of Science Coordination and 

Policy (7203M), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

mstockstill on DSK4VPTVN1PROD with NOTICES

35910 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

telephone number: (202) 564–1656; 

email address: west.pat@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be affected by this action if 

you produce, manufacture, use, or 

import chemicals (including pesticide 

chemicals) that may be found in sources 

of drinking water; if you manufacture or 

import chemicals that degrade to 

chemicals found in sources of drinking 

water; or if you are, or may otherwise 

be, involved in the testing of chemicals 

for potential endocrine effects. The 

following list of North American 

Industrial Classification System 

(NAICS) codes is not intended to be 

exhaustive, but rather provides a guide 

to help readers determine whether this 

document applies to them. Potentially 

affected entities may include: 

• Chemical manufacturers, importers, 

and processors (NAICS code 325), e.g., 

persons who manufacture, import, or 

process chemicals. 

• Pesticide, fertilizer, and other 

agricultural chemical manufacturers, 

importers, and processors (NAICS code 

3253), e.g., persons who manufacture, 

import, or process pesticide; fertilizer; 

or agricultural chemicals. 

• Scientific research and 

development services (NAICS code 

5417), e.g., persons who conduct testing 

of chemicals for endocrine effects. 

To determine whether you or your 

business may be affected by this action, 

you should carefully examine the 

applicability provisions in Unit III.C., 

and examine FFDCA section 408(p). If 

you have any questions regarding the 

applicability of this action to a 

particular entity, consult either 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

B. How can I get copies of this document 

and other related information? 

The docket for this action, identified 

by docket identification (ID) number 

EPA–HQ–OPPT–2007–1080, is available 

at http://www.regulations.gov or at the 

Office of Pollution Prevention and 

Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 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 telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http:// 

www.epa.gov/dockets. 

II. Background 

A. What action is the agency taking? 

The Agency is publishing final 

policies and procedures for issuing 

EDSP test orders for chemicals pursuant 

to the Agency’s authority under SDWA 

section 1457 (i.e., ‘‘SDWA chemicals’’). 

Section 1457 of the SDWA authorizes 

EPA to issue EDSP test orders to 

manufacturers and importers of 

chemicals that may be found in sources 

of drinking water and to which a 

substantial population may be exposed 

(42 U.S.C. 300j–17). SDWA chemicals 

encompass a wide variety of chemicals, 

including industrial and pesticide 

chemicals, ingredients in 

pharmaceuticals and personal care 

products, and degradates. 

These SDWA/FFDCA policies and 

procedures supplement the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA)/FFDCA policies and 

procedures that were published in the 

Federal Register issue of April 15, 2009 

(FIFRA/FFDCA policies and 

procedures) (Ref. 1). The FIFRA/FFDCA 

policies and procedures (Ref. 1) were 

developed primarily for the issuance of 

EDSP test orders on pesticide active and 

inert ingredients, which were the 

chemicals comprising the first EDSP 

chemical list (first list). Consequently, 

some of the FIFRA/FFDCA policies and 

procedures (Ref. 1) reflect issues 

uniquely associated with the pesticide 

market and the specific regulatory 

context under which EPA regulates 

pesticide chemicals. In this document, 

EPA describes the policies and 

procedures associated with the 

screening of SDWA chemicals, which 

include certain modifications to the 

FIFRA/FFDCA policies and procedures 

that are intended to address issues that 

are unique to SDWA chemicals, or to 

address the circumstances where other 

competing considerations for SDWA 

chemicals warrant a modification of the 

FIFRA/FFDCA policies and procedures. 

This document discusses the policy 

considerations for SDWA chemicals in 

the following areas: 

• Who would receive EDSP test 

orders for SDWA chemicals? Unit VI.A. 

• How will recipients of EDSP test 

orders for SDWA chemicals be notified? 

Unit VI.B. 

• How will the public know who has 

received an EDSP test order for a SDWA 

chemical or who has supplied data? 

Unit VI.C. 

• How will the agency minimize 

duplicative testing? Unit VI.D. 

• What are the potential responses to 

EDSP test orders for SDWA chemicals? 

Unit VI.E. 

• How can an EDSP test order 

responses and data be submitted 

electronically? Unit VI.F. 

• How will EPA facilitate joint data 

development, cost sharing, and data 

compensation for SDWA chemicals? 

Unit VI.G. 

• What procedures can EPA apply for 

handling Confidential Business 

Information (CBI) for SDWA chemicals? 

Unit VI.H. 

• What is the process for contesting 

an EDSP test order or consequences for 

failure to respond or comply with an 

EDSP test order? Unit VI.I. 

• What is the informal administrative 

review procedure? Unit VI.J. 

• What are the adverse effects 

reporting requirements? Unit VI.K. 

While the FIFRA/FFDCA policies and 

procedures (Ref. 1) remain relevant, 

SDWA chemical EDSP test order 

recipients are encouraged to refer to this 

document to fully understand all of the 

relevant policies and procedures. In 

addition, a new EDSP test order 

template for issuance of EDSP test 

orders under SDWA section 1457 and 

FFDCA section 408(p)(5) is available in 

the docket for this document (Ref. 2). 

EPA is publishing two related notices 

elsewhere in this Federal Register issue. 

One announces the final second EDSP 

chemical list (second list), which 

includes both SDWA chemicals and 

pesticide active ingredients (PAIs). The 

other announces the submission to the 

Office of Management and Budget 

(OMB) of the final Information 

Collection Request (ICR) Addendum 

that describes the estimated paperwork 

burden and costs associated with the 

second list. 

B. What are the statutory authorities for 

the policies discussed in this document? 

SDWA is the primary Federal law that 

ensures the quality of Americans’ 

drinking water. Under SDWA, EPA sets 

standards for drinking water and works 

closely with States, localities, and water 

suppliers to implement these standards. 

SDWA authorizes EPA to set national 

standards for drinking water to protect 

against both naturally occurring and 

man-made contaminants that may be 

found in drinking water (42 U.S.C. 

300g–1). 

Section 1457 of SDWA authorizes 

EPA to require testing, under FFDCA 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35911 

section 408(p) (21 U.S.C. 346(a)(p)), of 

any chemical that may be found in 

sources of drinking water if the EPA 

Administrator determines that a 

substantial population may be exposed 

to such chemical (42 U.S.C. 300j–17). 

Section 408(p)(1) of FFDCA requires 

EPA ‘‘to develop a screening program, 

using appropriate validated test systems 

and other scientifically relevant 

information, to determine whether 

certain substances may have an effect in 

humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other effects as [EPA] 

may designate’’ (21 U.S.C. 346a(p)(1)). 

Section 408(p)(3) of FFDCA expressly 

requires that EPA ‘‘shall provide for the 

testing of all pesticide chemicals’’ (21 

U.S.C. 346a(p)(3)). Section 201 of 

FFDCA defines ‘‘pesticide chemical’’ as 

‘‘any substance that is a pesticide within 

the meaning of [FIFRA], including all 

active and pesticide inert ingredients of 

such pesticide’’ (21 U.S.C. 231(q)(1)). 

Section 408(p)(5)(A) of FFDCA 

provides that the EPA Administrator 

‘‘shall issue an order to a registrant of 

a substance for which testing is required 

under [FFDCA section 408(p)], or to a 

person who manufactures or imports a 

substance for which testing is required 

under [FFDCA section 408(p)], to 

conduct testing in accordance with the 

screening program . . ., and submit 

information obtained from the testing to 

the Administrator, within a reasonable 

time period that the [Agency] 

determines is sufficient for the 

generation of the information’’ (21 

U.S.C. 346a(p)(5)(A)). 

The statutes discussed in this unit 

provide EPA with the discretion to 

require testing of a pesticide chemical 

under FFDCA alone, or in any 

combination of the various authorities 

(e.g., FIFRA/FFDCA, SDWA/FFDCA, or 

FIFRA/SDWA/FFDCA). 

Section 408(p)(5)(B) of FFDCA 

requires that, ‘‘to the extent practicable, 

the Administrator shall minimize 

duplicative testing of the same 

substance for the same endocrine effect, 

develop, as appropriate, procedures for 

fair and equitable sharing of test costs, 

and develop, as necessary, procedures 

for handling of confidential business 

information’’ (21 U.S.C. 346a (p)(5)(B)). 

Section 408(p)(5)(D) of FFDCA 

provides that any person (other than a 

registrant) who fails to comply with a 

FFDCA section 408(p)(5) test order shall 

be liable for the same penalties and 

sanctions as are provided for under 

section 16 of the Toxic Substances 

Control Act (TSCA) (21 U.S.C. 346a 

(p)(5)(D)). Such penalties and sanctions 

shall be assessed and imposed in the 

same manner as provided in TSCA 

section 16. Under TSCA section 16, civil 

penalties of up to $37,500 per day may 

be assessed, after notice and an 

administrative hearing held on the 

record in accordance with section 554 of 

the Administrative Procedure Act (APA) 

(15 U.S.C. 2615(a)(1)–(2)(A)). 

In addition, Congress’s House 

Appropriations Committee Report (H. 

Rept.) for EPA’s FY 2010 appropriations 

(Ref. 3), directed EPA ‘‘to publish 

within 1 year of enactment a second list 

of no less than 100 chemicals for 

screening that includes drinking water 

contaminants, such as halogenated 

organic chemicals, dioxins, flame 

retardants (PBDEs, PCBs, PFCs), plastics 

(BPA), pharmaceuticals and personal 

care products, and issue 25 orders per 

year for the testing of these chemicals.’’ 

C. Does this document contain binding 

requirements? 

While the requirements in the statutes 

and in any EDSP test orders ultimately 

issued under FFDCA section 408(p) are 

binding, the policies and procedures 

outlined in this document are not. The 

policies and procedures outlined in this 

document merely represent the general 

procedures and statutory interpretations 

on which EPA may rely to implement 

the existing goals of the statutory 

program. However, neither EPA nor any 

outside party is bound by any of the 

policies and procedures outlined in this 

document. Accordingly, these policies 

and procedures may be modified at any 

time by EPA and the Agency may depart 

from these policies and procedures 

where circumstances warrant and 

without prior notice. 

III. Background on EDSP 

A. What is EDSP? 

EPA developed EDSP in response to 

a Congressional mandate in FFDCA ‘‘to 

determine whether certain substances 

may have an effect in humans that is 

similar to an effect produced by 

naturally occurring estrogen, or such 

other endocrine effect as [EPA] may 

designate’’ (21 U.S.C. 346a(p)). As part 

of EDSP, EPA issues orders to collect 

certain test data on selected chemicals. 

In general, EPA intends to use the data 

collected under EDSP, along with other 

information, to determine if a pesticide 

chemical, or other chemicals, may pose 

a risk to human health or the 

environment due to disruption of the 

endocrine system. The determination of 

whether a chemical has the potential to 

interact with the endocrine system will 

be made on a weight of evidence basis 

taking into account data from the Tier 

1 assays and/or OSRI. Chemicals that go 

through Tier 1 screening and are found 

to have the potential to interact with the 

estrogen, androgen, or thyroid hormone 

systems will proceed to the next stage 

of EDSP where EPA will determine 

which, if any, of the Tier 2 tests are 

necessary based on the available data. 

Tier 2 testing is designed to identify any 

adverse endocrine-related effects caused 

by the chemical, and establish a 

quantitative relationship between the 

dose and that endocrine effect. Further 

information regarding EDSP and 

requirements for Tier 1 and Tier 2 can 

be found on the Agency’s EDSP Web 

site (Ref. 4). EPA is aware of no issue 

specific to the chemicals in the second 

list that would warrant any modification 

to the existing testing scheme, and is not 

proposing to adopt any. 

B. Why is EPA publishing additional 

policies and procedures for EDSP Tier 1 

screening? 

As stated in the FIFRA/FFDCA 

policies and procedures (Ref. 1), EPA 

intended to develop EDSP policies and 

procedures that could be used in 

subsequent data collection efforts, 

including those under SDWA, but 

indicated that EPA may make 

modifications as appropriate. The 

Agency now believes that modifications 

are needed to address issues that are 

specific to the larger universe of 

chemicals that are potentially subject to 

EDSP testing under SDWA. 

The FIFRA/FFDCA policies and 

procedures (Ref. 1) were originally 

developed for screening of pesticide 

chemicals and relied, in part, on a 

regulatory context that is specific to 

pesticide chemicals. The presumptions 

applicable in that context are not 

necessarily applicable to this larger 

universe of chemicals. 

For example, much of the data that 

would be generated in response to an 

EDSP test order (particularly for 

pesticide active ingredients) would be 

entitled to the data compensation 

protections available under FIFRA (7 

U.S.C. 136a(c)(1)(F)) and FFDCA (21 

U.S.C. 346a(i)). Additionally, FIFRA 

section 10 prohibits EPA from releasing 

study data on pesticide chemicals 

unless the person seeking access to the 

information certifies that he is not an 

agent or employee of any multinational 

pesticide company (7 U.S.C. 136h(g)). 

Because FFDCA section 408(p) did not 

authorize EPA to modify these FIFRA 

requirements, EPA needs to ensure that 

the policies and procedures adopted to 

implement FFDCA section 408(p) would 

operate in a manner that would be 

consistent with EPA’s existing FIFRA 

mandates. Moreover, EPA could rely on 

the existing FIFRA mechanisms to 

mstockstill on DSK4VPTVN1PROD with NOTICES

35912 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

effectively minimize duplicative testing, 

and to promote cost-sharing. 

By contrast, these considerations are 

generally not applicable to the majority 

of chemicals that may be subject to 

EDSP screening under SDWA, such as 

chemicals used in pharmaceuticals and 

personal-care products, among others. 

In addition, the statutory authority for 

imposing testing of SDWA chemicals, 

the sources of SDWA chemicals, and 

EPA’s ability to identify manufacturers 

and importers, and other considerations 

unique to SDWA chemicals, create a 

need for policies and procedures 

specific to EDSP screening under 

SDWA/FFDCA authority. For example, 

some registered pesticide ingredients 

have additional uses that account for a 

much larger percentage of total 

manufacture and import. In such cases, 

the Agency seeks to be able to identify, 

and issue orders to, all relevant 

manufacturers and importers in a 

manner that creates a fair and level 

playing field for complying with the 

order. 

C. When do these policies and 

procedures apply? 

EPA has the discretion to issue EDSP 

test orders under the authorities of 

SDWA section 1457 and FFDCA section 

408(p) for all chemicals, including PAIs, 

for which the Agency can make the 

requisite factual findings. As described 

in this document, however, EPA 

generally intends to use SDWA 

authority to require EDSP testing of 

SDWA chemicals that are not PAIs and 

FIFRA authority to require EDSP testing 

of PAIs and pesticide inerts, even if the 

PAIs and inerts have non-pesticide uses. 

EPA may issue SDWA/FFDCA EDSP 

test orders for PAIs and inerts that have 

non-pesticide uses, except, when PAI 

registrants avoid EDSP testing by 

canceling their registrations and leaving 

the market. This approach will preserve 

familiar data compensation and 

confidentiality protections established 

in FIFRA sections 3(c)(1)(F) and 12, as 

well as FFDCA section 408(i), for 

pesticide registrants. 

IV. EDSP Policies and Procedures 

Considerations for SDWA Chemicals 

The Agency used the following 

policies and procedures considerations 

to guide development of policies and 

procedures for issuing Tier 1 EDSP test 

orders on SDWA chemicals: 

• A core part of EPA’s mission is to 

promote public understanding of the 

potential risks posed by chemicals in 

commerce. 

• The basis for an order with respect 

to SDWA chemicals is that a chemical 

may be found in sources of drinking 

water and a determination that a 

substantial population may be exposed 

to such chemical. Thus, SDWA/FFDCA 

policies and procedures should not be 

unnecessarily tied to the use of the 

chemical in any given market and 

should instead focus on obtaining data 

from companies that might be expected 

to contribute to a chemical’s presence in 

drinking water. 

• For simplicity, policies and 

procedures for SDWA chemicals should 

be consistent with FIFRA/FFDCA 

policies and procedures (Ref. 1) unless 

there is a reason for modifying them 

(e.g., different statutory requirements), 

though for clarity EPA has written these 

SDWA/FFDCA policies and procedures 

as a complete, stand alone document. 

• Procedures for EDSP testing of 

SDWA chemicals should strive to 

minimize duplicative testing and 

promote fair and equitable sharing of 

test costs, as described in FFDCA 

section 408(p)(5)(B). 

• The Agency expects to issue 

SDWA/FFDCA EDSP test orders for 

pesticide inert ingredients that are listed 

for EDSP screening with a SDWA 

section 1457 finding; it has also been 

the Agency’s experience that pesticide 

inerts generally have a much larger 

market than solely as ingredients in 

pesticide formulations. For these 

reasons EPA believes it is reasonable 

and equitable to initially issue SDWA/ 

FFDCA EDSP test orders on SDWA 

chemicals that are not PAIs. 

• As noted previously, EPA intends 

to require EDSP testing pursuant to 

FIFRA and FFDCA for registrants of a 

pesticide chemical, even if the chemical 

has non-pesticide uses. If, however, 

recipients of such EDSP test orders fail 

to provide the required information by 

dropping out of the pesticide market to 

avoid EDSP testing, EPA may choose to 

reissue EDSP test orders under SDWA/ 

FFDCA authority if the SDWA criteria 

are met. EPA would then rely on the 

policies and procedures established in 

this document. 

V. Discussion of Final SDWA/FFDCA 

Policies and Procedures and Response 

to Comments 

This document adopts the proposed 

SDWA/FFDCA policies and procedures 

published in the Federal Register issue 

of November 17, 2010 (Ref. 5), with 

minor revisions. The Agency reviewed 

and considered all of the comments that 

were received on the proposed SDWA/ 

FFDCA policies and procedures. All of 

the comments received are available in 

the docket for this document, and a 

response-to-comments document (Ref. 

6) that summarizes and responds to all 

of the comments received on the 

proposed SDWA/FFDCA policies and 

procedures is also available in the same 

docket. The Agency specifically 

requested comments on five topics: 

Response option to cease manufacture; 

persistence; catch-up orders and data 

compensation; orphan chemicals; and 

electronic notification. The Agency’s 

consideration of such comments is 

described in this unit and the Agency’s 

response to comments document (Ref. 

6). 

A. Response Option To Cease 

Manufacture 

EPA sought comment on whether a 

company could satisfy the EDSP test 

order simply by committing to stop 

manufacturing or importing a SDWA 

chemical, because, in ceasing to 

manufacture the chemical, the company 

thereby stops contributing to the 

presence of the chemical in the source 

of drinking water and reduces potential 

exposure. Alternatively, EPA sought 

comment on whether the company 

should be required to conduct the EDSP 

testing nevertheless, on the grounds that 

the company should not be able to 

evade responsibility for providing the 

data necessary to evaluate the existing 

water contamination to which their 

manufacturing activities had 

contributed. 

Multiple commenters (the American 

Petroleum Institute (API), the American 

Chemistry Council (ACC), Bayer 

CropScience LP (BCS), Croplife America 

(CLA), and the Chemical Producers and 

Distributors Association (CPDA)) agreed 

with EPA’s proposal to allow a EDSP 

test order recipient for the second list to 

comply with an EDSP test order by 

ceasing all manufacturing of the listed 

chemical, because former manufacturers 

will not receive any new income from 

the chemical to pay for the new EDSP 

testing requirement and language in the 

statute refers to manufacture and 

production in the present tense. The 

San Francisco REACH Team (SFRT) 

requested that EPA’s EDSP test order 

procedures be revised to include a clear 

timeline for when the production must 

cease. 

EPA intends to allow a SDWA EDSP 

test order recipient for the second list to 

comply with the test order by ceasing all 

manufacturing, including 

manufacturing for export only, and 

importing of the listed chemical. EPA 

considers this approach to be consistent 

with the language of the statute and 

with the decision to accept pesticide 

cancellation as an acceptable response 

to an EDSP test order issued under 

FIFRA. EPA will require recipients to 

provide a timeline for the cessation of 

production as part of the explanation 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35913 

and documentation supporting the 

claim. Rather than specifying a single 

timeline, the Agency will take 

individual circumstances into account, 

essentially using the same procedure it 

applies to accepting pesticide 

cancellations as an acceptable response 

to an EDSP test order on a pesticide 

active ingredient. 

The American Water Works 

Association (AWWA) commented that 

an EDSP test order recipient should not 

be allowed to respond by ceasing 

manufacture, observing that this would 

not absolve them from having 

contributed to the presence of the 

chemical in the environment, and that 

it might persist in the environment. 

While the comment has merit, EPA 

has decided that, in this instance, the 

equities weigh in favor of allowing 

companies to satisfy the order by 

entirely ceasing to manufacture the 

chemical. As discussed in the draft 

SDWA/FFDCA policies and procedures 

(Ref. 5), a number of considerations 

weigh against requiring manufacturers 

who choose to cease manufacture of the 

chemical to nevertheless conduct EDSP 

testing. Specifically, if an EDSP test 

order recipient stops manufacturing and 

importing a chemical, it will ultimately 

lead to less exposure to the chemical in 

sources of drinking water. (The decline 

will happen at different rates, 

depending on the chemical and whether 

the chemical is found in surface water 

or ground water.) Moreover, an order 

recipient who ceases to manufacture or 

import a chemical that is subject to 

EDSP testing will no longer receive any 

economic benefit from the sale of the 

chemical with which to defray the cost 

of testing. This approach will effectively 

focus the costs on those companies that 

can best bear the costs of testing. 

Further, as discussed in this unit, EPA 

has been unable to develop an effective 

mechanism for issuing EDSP test orders 

to past registrants, manufacturers, and 

importers given the practical, legal, and 

equitable difficulties of identifying and 

assessing the contributions of past 

participants. However, if EPA is unable 

to obtain information on most chemicals 

for which there is continued and 

ongoing significant exposures, EPA may 

revisit the issue. 

B. Persistence 

EPA sought comment on whether, and 

how, to factor chemical persistence into 

EDSP policies and procedures to 

account for the contribution associated 

with past registrants, manufacturers and 

importers, to the presence of a chemical 

in a source of drinking water, given that 

the Agency’s policy has been to only 

issue orders to current registrants, 

manufacturers, and importers. 

Multiple commenters (API, People for 

the Ethical Treatment of Animals 

(PETA) and the Physicians Committee 

for Responsible Medicine (PCRM), ACC, 

BCS, and CLA and the Endocrine Policy 

Forum (EPF)) indicated that EPA should 

not consider a chemical’s persistence in 

the environment when implementing 

EDSP, noting among other things that 

‘‘persistence’’ does not appear in the 

language of the FFDCA and asserting 

that it is subject to differing 

interpretations. Commenters observed 

that the issue of persistence is most 

likely to arise only for chemicals that 

have not been manufactured and used 

by anyone for a significant period of 

time (i.e., ‘‘legacy chemicals’’). Some 

commenters observed EPA would have 

to develop a legal and equitable process 

for identifying those chemicals along 

with all past manufacturers and 

importers, many of whom may not have 

manufactured or imported the chemical 

for decades. 

Two commenters (SFRT and AWWA) 

advocated that EPA should hold 

accountable all past registrants, 

manufacturers, and importers that have 

contributed to health and environmental 

impacts from past production activities, 

even if they are no longer actively 

manufacturing or importing a particular 

chemical, because chemicals persist in 

the environment, the consequences 

often become apparent decades after the 

cessation of exposure to a chemical, and 

companies should share the cost of 

generating data. 

Under SDWA, EPA issues an EDSP 

test order based upon a finding that a 

chemical ‘‘may be found in sources of 

drinking water’’ and ‘‘that a substantial 

population may be exposed.’’ While 

EPA believes that persistence can be 

defined (persistence is a factor in a 

variety of EPA’s water and toxics 

programs; e.g., 40 CFR 125.122, 141.24, 

711.6, 792.3, 795.70, 796.1050, 

798.2250, and 799.5075), SDWA does 

not explicitly address how to factor in 

the possible presence of a chemical in 

a source of drinking water from past 

manufacturing and importing. And, 

although, EPA believes that the 

potential long term impacts of a 

persistent chemical in sources of 

drinking water is an important 

consideration, EPA has not been able to 

develop an effective mechanism for 

issuing EDSP test orders to past 

registrants, manufacturers, and 

importers given the practical, legal, and 

equitable difficulties of identifying and 

assessing the contributions of past 

participants. Accordingly, EPA does not 

intend at this time to issue test orders 

to entities other than current registrants, 

manufacturers, and importers. 

For more information on how EPA 

addresses commenters’ concerns about 

chemical persistence, see the comment 

response document for the second list of 

chemicals (Ref. 7). 

C. Catch-Up Orders and Data 

Compensation 

EPA sought comment on ‘‘whether 5 

years is the appropriate length of time 

that the Agency should continue to 

issue SDWA/FFDCA catch-up orders as 

a means to ensure equitable sharing of 

test costs.’’ (Five years is the length of 

time that data compensation is available 

for test rules issued under TSCA section 

4. (See 40 CFR part 791.)) 

The Methanol Institute argued that 

SDWA chemicals should be entitled to 

the same 15-year compensation period 

as pesticide chemicals, stating there was 

no logical reason to distinguish between 

SDWA chemicals and pesticide 

chemicals since both categories of 

chemicals are being subjected to the 

same testing requirements pursuant to 

the same legislative enactment. The 

SFRT and the ACC took similar 

positions. In addition, the 15-year 

compensation period applies to 

industrial chemicals used as inerts in 

pesticides as well. 

After carefully considering these 

comments and the equities involved, 

EPA has concluded that the most 

appropriate length of time to issue 

SDWA/FFDCA catch-up orders is in fact 

the same 15-year compensation period 

as for active and inert pesticide 

chemicals because it will provide a 

consistent standard across the entire 

EDSP. Neither SDWA nor the FFDCA 

authorized EPA to identify 

manufacturers or importers of SDWA 

chemicals through mandatory 

registration provisions, such as those 

that apply to pesticide registrants. 

Furthermore, an inconsistency would 

develop if SDWA chemicals are not 

entitled to the same 15-year 

compensation period as the first list of 

chemicals, pesticides, particularly if 

they are mandates to the same testing 

requirements pursuant to the same 

legislative enactments. 

D. Orphan Chemicals 

EPA sought comment on the 

mechanisms available for testing 

chemicals for which EDSP test orders do 

not generate the necessary data. 

AWWA asserted that water utilities 

are not manufacturers that can be 

required to test under FIFRA or TSCA, 

so disinfection byproducts and arsenic 

and other naturally occurring chemicals 

should be considered orphan chemicals 

mstockstill on DSK4VPTVN1PROD with NOTICES

35914 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

and EPA should screen and test those 

chemicals itself. 

The BCS, PETA, and PCRM 

interpreted orphan chemicals as those 

chemicals no longer being produced or 

imported and reasoned that as 

environmental exposures to such 

chemicals would decrease over time, 

testing of such chemicals should not be 

required and resources to conduct 

testing should not be expended either 

by private parties or by the Agency 

without a documented rationale for why 

potentially harmful endocrine effects 

might be anticipated. 

Exposure to chemicals that are no 

longer being produced or imported may 

not decrease over time if the chemicals 

occur naturally or are persistent and 

bioaccumulative. However, exposure 

also will not increase from any 

continuing manmade contribution to 

environmental loading. As discussed in 

Unit V.A., EPA has not been able to 

develop an effective mechanism for 

issuing EDSP test orders to past 

registrants, manufacturers, and 

importers, and has, therefore, concluded 

not to issue test orders for chemicals 

that are no longer being manufactured 

or imported (see Unit V.B.). In addition, 

without reaching any conclusion with 

respect to whether water utilities can 

ever be manufacturers, EPA has not 

sought to require the testing of 

disinfection byproducts and arsenic or 

other naturally occurring chemicals as 

part of this second list of chemicals, but 

this issue warrants additional 

consideration. 

E. Electronic Notification 

EPA sought comment on whether 

companies that already have a Central 

Data Exchange (CDX) account with EPA 

would prefer to receive an EDSP 

notification electronically as opposed to 

notification by means of the U.S. Postal 

Service, either as a standard procedure 

or by request, and on mechanisms by 

which EPA could accurately document 

the receipt of orders through electronic 

reporting mechanisms. 

API commented that it generally 

supported electronic reporting but, for 

EDSP, recommended that electronic 

notification be optional, since there 

have been technical problems with 

electronic reporting in other EPA 

programs. 

Electronic reporting has become the 

standard mode of operation in business 

and government and provides 

overwhelming advantages over paper 

submissions. The OPPT’s 

premanufacture notice (PMN) and 

Chemical Data Reporting (CDR) rules 

(formerly known as the Inventory 

Update Reporting (IUR) rule) already 

require use of the Internet to 

electronically report. OPPT has also 

proposed additional electronic reporting 

requirements (Ref. 8). 

Electronic reporting requires use of 

EPA’s CDX, the point of entry on the 

Environmental Information Exchange 

Network for environmental data 

submissions to the Agency. Currently, 

CDX has provided stakeholders with the 

ability to: 

1. Submit data through one 

centralized point of access and fill out 

a single electronic form which can be 

submitted instantaneously instead of 

mailing multiple paper forms. 

2. Receive Agency confirmation when 

submissions are received. 

3. Reduce costs associated with 

submitting and processing data 

submissions. 

4. Pay fees through https:// 

www.pay.gov. 

5. Utilize publishing services to share 

information collected by EPA with other 

stakeholders. 

In an effort to streamline the reporting 

process, reduce the administrative costs, 

and maintain consistency with other 

electronic reporting of information 

submissions and recordkeeping (Ref. 8), 

EPA will require EDSP test order 

information to be submitted 

electronically. EPA will continue to 

issue EDSP test orders by U.S. Postal 

Service for the second list of chemicals. 

F. Identification of EDSP Test Order 

Recipients 

Though EPA did not specifically 

request comment on the identification 

of EDSP test order recipients, some 

comments were received. 

API agreed with EPA that the CDR 

rule is the appropriate source for 

identifying current chemical 

manufacturers and importers, but 

recommended that EPA only use the 

Toxics Release Inventory (TRI) as a last 

resort, because TRI was less specific. 

AWWA commented that EPA should 

clarify what entities the EDSP test 

orders apply to by defining all terms 

describing potentially affected entities. 

The ACC commented that EPA should 

pay close attention to manufacturing 

and other activities that contribute to 

the occurrence of chemicals in drinking 

water to which a substantial population 

may be exposed, with an emphasis on 

the equitable sharing of the cost of 

testing. 

EPA believes it is ‘‘important to 

identify and issue orders to all 

significant manufacturers and importers 

of a listed chemical’’ and the Agency 

intends to rely on the CDR rule, which 

periodically requires manufacturers and 

importers to report chemical production 

information to EPA for chemicals 

manufactured (including imported) in 

amounts of 25,000 lb or more at a single 

site. EPA considers the CDR rule to be 

a reliable means of identifying 

manufacturers and importers of nonpesticide, industrial chemicals and 

believes that the CDR rule generally 

accounts for most of such chemicals in 

commerce. EPA intends to use other, 

publicly available databases, such as, 

but not limited to, TRI, to identify 

possible EDSP test order recipients. EPA 

disagrees that the TRI data are 

imprecise. TRI data are reported 

annually and reporters must indicate if 

they manufacture, including import, a 

listed chemical as well as more specific 

information on the manufacture of the 

chemical. EPA is aware that any given 

database, including CDR and TRI, is 

imperfect and has limitations. On the 

whole, however, EPA believes that CDR 

and TRI constitute comprehensive and 

generally reliable databases. Moreover, 

no commenter disagreed with EPA’s 

assessment or submitted any 

information to rebut EPA’s conclusions. 

In addition, EPA believes that relying 

on these databases effectively addresses 

the AWWA request that EPA clarify the 

entities that will be subject to EDSP test 

orders, and for a definition of all terms 

describing potentially affected entities. 

The rules that establish the reporting 

requirements for these databases (40 

CFR parts 372 and 711) already include 

definitions of all of the necessary terms 

and should be already familiar to the 

regulated community. Nonetheless, EPA 

asked for, and continues to be interested 

in learning about, any other credible 

source or method that may be used to 

identify EDSP test order recipients. In 

the final analysis, the objective is to 

identify responsible manufacturers and 

importers of relevant chemicals, and not 

to apportion responsibility. EDSP test 

order recipients may combine in 

consortia to conduct the required testing 

on whatever basis they find most 

suitable. 

SFRT asked that EPA ‘‘incorporate a 

system which takes into account the 

location of chemical manufacturers and 

potential disproportionate burden on 

neighboring communities, in addition to 

production volume, when issuing test 

orders’’ in order to ‘‘account for the 

unequal geographic distribution of 

manufacturing locations of these 

chemicals and the potential impact of 

neighboring communities from a 

chemical’s presence in the drinking 

water among other sources.’’ SFRT also 

recommended that, in order to ‘‘avoid 

disproportionate burdens and promote 

equitable responsibility among 

manufacturers,’’ EPA issue EDSP test 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35915 

order to ‘‘all manufacturers of listed 

chemicals . . . with the exception of 

manufacturers using small quantities of 

the listed chemical (reported in grams 

instead of lbs.) for research and 

development purposes only.’’ 

EPA believes it is ‘‘important to 

identify and issue orders to all 

significant manufacturers and importers 

of a listed chemical.’’ The Agency 

intends to rely on the CDR rule, as well 

as TRI, both of which periodically 

require manufacturers and importers to 

report chemical production information 

to EPA for chemicals manufactured 

(including imported) in amounts of 

25,000 lb or more at a single site. EPA 

considers the CDR rule to be the most 

reliable means of identifying 

‘‘significant’’ manufacturers and 

importers of non-pesticide, industrial 

chemicals and believes that the CDR 

rule generally accounts for most of such 

chemicals in commerce. It is unclear 

what the commenter intends by 

requesting that EPA require selfdisclosure in this context, as the only 

vehicle for requirements relating to 

EDSP testing in this context will be the 

EDSP test orders, and EPA can only 

issue the orders to those manufacturers 

it can identify. Nonetheless, EPA is 

interested in finding other existing 

sources for reliably identifying EDSP 

test order recipients and will consider 

issuing EDSP test orders to other 

significant manufacturers and importers 

that are identified. EPA, however, does 

not intend to issue test orders to 

companies that only manufacture and/ 

or import a chemical in small amounts 

for research and development or in 

amounts more appropriately measured 

in grams rather than thousands of 

pounds. Issuing EDSP test orders based 

on the geographic distribution of 

manufacturing locations and potential 

impact of chemicals on neighboring 

communities is, at least, not an express 

part of the basic requirement that EPA 

identify and issue EDSP test orders to 

chemical manufacturers and importers 

and would add another complex and 

potentially burdensome requirement to 

the issuance of EDSP test orders that 

appears unnecessary and unlikely to 

achieve the primary goal of the program: 

To obtain the necessary data to evaluate 

the endocrine potential of pesticide 

chemicals and drinking water 

contaminants. 

G. Other Topics 

1. Cost sharing. ACC, CLA, EPF, and 

CPDA stated that EPA had developed a 

workable data compensation and cost 

sharing plan and agreed with EPA’s 

decision to issue catch-up orders to 

require cost sharing by manufacturers 

and importers who enter the market 

after initial orders are issued (but 

suggested that such orders be issued for 

10 instead of 5 years), but recommended 

that EPA develop new procedures in the 

form of explicit, legally enforceable 

compensation rights to ensure fair and 

equitable sharing of test costs. 

Section 408(p) of FFDCA only 

authorizes EPA to create procedures that 

operate within the confines of existing 

statutory authority and to develop 

procedures to facilitate joint data 

generation. EPA, however, is authorized 

to determine what actions comply with 

a FFDCA section 408(p) test order and 

intends to use this discretion to create 

strong incentives for companies to 

jointly volunteer to develop EDSP test 

data under the circumstances 

enumerated in Unit VI.G. 

2. Minimizing duplicative testing. 

PETA and the PRCM commented that 

EPA should mandate, and create 

incentives to form testing consortia. 

EPA does not have the authority to 

compel EDSP test order recipients to 

join testing consortia to minimize 

testing, but may develop procedures to 

facilitate joint data generation. In 

particular, EPA has the discretion to 

determine what constitutes compliance 

with an EDSP test order and can 

exercise that discretion to allow cost 

sharing and the joint electronic 

submission of data by EDSP test order 

recipients, in appropriate 

circumstances, to reduce costs and 

duplicative testing. EPA intends to 

continue to list other manufacturers and 

contact information in each EDSP test 

order as well as providing such 

information on the Agency’s EDSP Web 

site. 

3. CBI. SFRT commented that EPA 

should strictly disallow CBI claims. The 

ACC, CLA, and EPF commented that 

FFDCA authorized, and EPA should 

provide, EDSP-specific CBI protection, 

which was critical to protect industry’s 

legitimate intellectual property 

interests. 

FFDCA does not authorize EPA to 

either create new rights or to modify 

existing rights to confidentiality. Rather, 

FFDCA only directs EPA to apply the 

confidentiality provisions in existing 

statutory authorities: FIFRA, the 

Freedom of Information Act (FOIA), and 

the Trade Secret Act (TSA), as 

applicable. SDWA, in particular, only 

authorizes EPA to apply CBI protection 

under the TSA. Data submitted to EPA 

in response to an order issued under 

SDWA/FFDCA for non-pesticide 

chemicals, for example, would only 

have the protections provided under 

FOIA and TSA. 

4. Adverse effects reporting. ACC 

commented that EPA has not, but 

should, give clear guidance on the 

significance of positive Tier 1 test 

results for TSCA section 8(e) and FIFRA 

section 6(a)(2) reporting purposes. 

EPA made a considered decision not 

to reinterpret the existing requirements 

for Tier 1 data, nor to otherwise take 

steps to amend the existing 

requirements. Rather, EPA referenced 

the existing regulatory provisions of 40 

CFR part 159 and existing 

interpretations of TSCA section 8(e). In 

general, EPA does not believe that data 

from a single Tier 1 assay that provides 

some evidence that a chemical may 

have the potential to interact with the 

endocrine system necessarily meets the 

standard for information that must be 

reported in accordance with FIFRA 

section 6(a)(2) or TSCA section 8(e) in 

all cases. In addition, EPA believes that 

it has not yet accumulated adequate 

experience with the Tier 1 results to be 

able to provide general guidance as to 

the significance of positive results from 

Tier 1 assays for purposes of the 

reporting requirements under FIFRA 

section 6(a)(2) or TSCA section 8(e). 

Under existing procedures, the 

determination to report is to be made by 

the company in the first instance, on a 

case-by-case basis, taking into account 

all circumstances, and EPA is not aware 

of any reason to change that with 

respect to EDSP data. Accordingly, to 

the extent that Tier 1 information meets 

the standards laid out in EPA’s 

regulations (40 CFR part 159), or falls 

within the categories described in EPA’s 

past statements regarding TSCA section 

8(e) (Ref. 9), that information should 

continue to be reported, consistent with 

those requirements. 

Any information previously 

submitted to EPA under FIFRA section 

6(a)(2), TSCA section 8(c), or TSCA 

section 8(e) need not be resubmitted to 

EPA in response to an EDSP test order, 

because EPA would already have the 

data. 

5. Public availability of information. 

SFRT commented that the EDSP test 

data on SDWA chemicals should be 

made publicly available on EPA’s Web 

site. 

EPA intends to make all nonconfidential EDSP data publicly 

available on the Agency’s EDSP Web 

site. However, TSA and FOIA may 

apply and provide some protections 

against disclosure and it may not be 

possible to publicly post all available 

data. Nonetheless, EPA expects that 

confidential data will be limited, and 

health and safety data for chemicals on 

the non-confidential TSCA Chemical 

Substance Inventory (TSCA Inventory) 

mstockstill on DSK4VPTVN1PROD with NOTICES

35916 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

of existing chemicals, which all of the 

SDWA chemicals are, may not be 

entitled to confidential treatment. 

6. OSRI and Weight-of-Evidence 

(WoE). ACC, CLA, EPF, and CPDA 

commented that EPA’s offer to accept 

OSRI in lieu of EDSP test data was 

justified, but that EPA had not clearly 

articulated a basis for evaluating OSRI. 

ACC, CLA, EPF, and CPDA also 

commented that EPA needed to develop 

meaningful WoE guidelines for 

assessing voluminous Tier 1 EDSP data 

to determine whether a chemical 

interacts with the endocrine system and 

publish peer reviewed guidance for 

conducting WoE evaluations. 

EPA issued guidance on OSRI for Tier 

1 test orders in 2009 (Ref. 10) and on 

WoE approach evaluating Tier 1 

screening results in 2011 (Ref. 11). 

7. Communications: Consistent use of 

language and definitions. API, ACC, 

CLA, and EPF commented that, given 

the sensitivity of the issue of endocrine 

disruption, EPA should be careful to use 

clear and accurate definitions for all 

important EDSP terms and to 

communicate clearly, accurately, and 

consistently to the public and within 

the Agency in order to avoid confusion 

and misunderstanding. 

EPA generally agrees with these 

comments and has made every effort to 

be as clear, concise, and unambiguous 

as possible. EPA has, for example, 

generally adhered to widely accepted 

definitions, such as the World Health 

Organization’s (WHO) definition of 

‘‘endocrine disruptor’’ as ‘‘an exogenous 

substance or mixture that alters 

function(s) of the endocrine system and 

consequently causes adverse health 

effects in an intact organism’’ (Ref. 12). 

EPA has also repeatedly cautioned that 

the public should not presume that the 

listing of a chemical or substance 

indicates in any way that EPA currently 

suspects that such chemical or 

substance interferes with the endocrine 

systems of humans or other species. 

EPA plans on maintaining these 

communications in future EDSP 

documents. See also EPA’s response to 

comments documents (Refs. 7 and 13). 

8. Schedule. API, SFRT, ACC, BCS, 

CLA, EPF, and CPDA commented that 

EPA should not issue EDSP orders for 

the second list of chemicals or for Tier 

2 testing until the data from the first list 

had been evaluated and the Tier 1 

assays had been examined in light of 

those data. 

The Agency intends to complete 

review of the Tier 1 data from the EDSP 

test orders issued for the first list of 

EDSP chemicals before issuing Tier 1 

test orders for the second list of EDSP 

chemicals. EPA intends to continue to 

rely on the available validated methods 

and to follow the recommendations in 

the 1999 report from the joint meeting 

of the Agency’s Science Advisory Board 

(SAB) and FIFRA Scientific Advisory 

Panel (SAP) (Ref. 14). The steps for this 

process are described in the EDSP 

Comprehensive Management Plan 

issued in 2012 (Ref. 15). With these 

recommendations, the Agency improves 

the validating screening and testing 

methods to develop complete 

information on chemicals being tested. 

In continuing with this process of 

developing efficiency, the Agency does 

not intend to release any finalized EDSP 

Tier 1 WoE decisions until the EDSP 

Tier 2 protocols are available. 

9. Enforcement. SFRT commented 

that EPA should enact a system of 

graduated penalties for noncompliance 

with testing requirements based on the 

length of delay in complying with 

requirements. 

EPA agrees that graduated penalties 

are generally appropriate, and has 

generally exercised its discretion 

consistent with that policy. For nonpesticides, failure to comply with an 

EDSP order carries the same civil and 

criminal penalties set out in TSCA 

section 16, under which each new day 

of continued noncompliance is another 

violation, so graduated penalties based 

on the length of delay are already built 

into the law. For pesticide chemicals, 

the FFDCA imposes more specific 

requirements with respect to the penalty 

for non-compliance, although they are 

generally consistent with the concept 

that penalties should be tied to the 

period of non-compliance. FFDCA 

section 408(p)(5)(C) requires the 

suspension of the pesticide registration 

for the period of non-compliance, and 

specifies that the suspension shall be 

terminated upon a determination that 

the registrant is no longer out of 

compliance. 

10. Other comments. EPA also 

received comments on topics that do not 

address aspects of the policies and 

procedures for issuing EDSP test orders, 

e.g., the use of SDWA authority to issue 

orders, the basis of SDWA chemical 

selection, and the second list of 

chemicals. The comments related to 

SDWA and the second list of chemicals 

are addressed in EPA’s response to 

comments document prepared for the 

second list of chemicals (Ref. 7). 

VI. Final Procedures for EDSP Tier 1 

Screening Pursuant to SDWA 

For purposes of discussing the EDSP 

policies and procedures in this 

document, SDWA chemicals can be 

described as either currently registered 

PAIs (SDWA PAIs) or ‘‘Other SDWA 

Chemicals’’ (including inert ingredients 

in currently registered pesticide 

products). EPA generally intends to 

issue FIFRA/FFDCA orders to 

manufacturers and registrants of PAIs, 

but would retain the discretion to issue 

an SDWA/FFDCA test order to any 

chemical that meets the statutory 

criteria in SDWA section 1457. 

Consequently, for any pesticide 

chemical that also has non-pesticidal 

uses, in the event that no FIFRA/FFDCA 

test order recipient generates the 

required data because all order 

recipients opt out of the pesticide 

market, EPA may decide to issue EDSP 

testing orders based on the SDWA 

authority in order to obtain the data. In 

such instances, the policies and 

procedures outlined in this document 

would be applicable. 

By contrast, for SDWA chemicals that 

are not PAIs, (i.e., ‘‘Other SDWA 

Chemicals’’), EPA generally intends to 

rely on SDWA section 1457 and/or 

FFDCA section 408(p)(5) to issue EDSP 

test orders. The Other SDWA Chemicals 

are very similar to the non-food use 

inert ingredients discussed in the 

FIFRA/FFDCA policies and procedures 

(Ref. 1), and the similarities are reflected 

in the policies that EPA has adopted in 

this document. Unit VI. describes the 

policies and procedures that relate to 

EDSP test orders issued under SDWA/ 

FFDCA authority. 

A. Who would receive EDSP test orders 

on SDWA chemicals? 

EPA believes it is important to 

identify and issue orders to all 

significant manufacturers and importers 

of a listed chemical. Under FFDCA 

section 408(p)(5)(A), EPA ‘‘shall issue’’ 

EDSP test orders ‘‘to a registrant of a 

substance for which testing is required 

. . . or to a person who manufactures or 

imports a substance for which testing is 

required . . .’’ (21 U.S.C. 

346(a)(p)(5)(A). The process EPA 

generally intends to use to issue EDSP 

test orders for SDWA chemicals 

depends on whether the chemical is a 

SDWA PAI or an Other SDWA 

Chemical. A chart depicting the process 

for issuing EDSP test orders on SDWA 

chemicals is included in the docket 

(Ref. 16). 

As noted, the Agency generally 

intends to issue orders under FIFRA/ 

FFDCA for SDWA PAIs, and to rely on 

the FIFRA/FFDCA policies and 

procedures (Ref. 1). As described in that 

document, EPA intends to use internal 

databases—principally the Office of 

Pesticide Program’s Information 

Network (OPPIN)—to identify technical 

registrants with a current pesticide 

registration containing a SDWA 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35917 

chemical as the active ingredient, and 

anticipates issuing a FIFRA/FFDCA test 

order to all identified technical 

registrants. 

For Other SDWA Chemicals, EPA 

generally intends to rely on information 

reported to the Agency under the TSCA 

CDR rule (Ref. 17) and TRI to identify 

the initial SDWA/FFDCA test order 

recipients. The CDR rule and TRI 

require manufacturers and importers of 

certain chemicals included on the TSCA 

Inventory to report site and 

manufacturing information for 

chemicals manufactured (including 

imported) in amounts of 25,000 lb. or 

more at a single site, or, for TRI, other 

lower thresholds as specified. The 

Agency believes that this information is 

an appropriate source for identifying 

EDSP test order recipients. It has been 

EPA’s experience that relying on 

companies that have reported to the 

CDR is the most reliable mechanism for 

identifying manufacturers and importers 

of (non-pesticide) industrial chemicals. 

Such manufacturers and importers are 

required, by regulation, to report under 

the CDR rule. Companies that report 

under the CDR rule generally account 

for most of a chemical in commerce 

(therefore, in many instances, these 

companies can be expected to account 

for most of a chemical when it is found 

in drinking water), which is the basis for 

listing a chemical under SDWA 

authority (see Unit II.B.). As relatively 

large manufacturers and importers, EPA 

also believes that companies reporting 

under CDR comprise the majority of the 

volume associated with the chemical; 

these companies are more likely to be 

able to afford the cost of EDSP testing 

than companies manufacturing volumes 

below the CDR reporting threshold. EPA 

believes that, in general, these 

manufacturers are analogous to the 

technical registrants, who received 

orders in the first round of EDSP 

screening. Finally, using the CDR 

information to identify order recipients 

will facilitate joint data development, as 

reporters for these chemicals are 

generally publicly known and not 

numerous. 

If there are no companies reporting in 

response to the CDR rule for a given 

chemical, EPA intends to use other 

publicly available databases, such as the 

TRI, to identify other major EDSP test 

order recipients. For Other SDWA 

Chemicals that are regulated or tracked 

by another agency (e.g., pharmaceuticals 

by the Food and Drug Administration), 

EPA may also consult with that agency 

as appropriate to identify main 

manufacturers and importers. In 

addition to using CDR, TRI, and other 

Federal agency databases, EPA also 

generally intends to issue orders to 

manufacturers and importers who are 

subsequently identified as such. The 

Agency will follow up on any new 

information it receives to this effect and 

issue orders accordingly. EPA, however, 

does not generally intend at this time to 

issue orders to companies that 

manufacture or import a chemical for 

research and development purposes 

only, or who otherwise manufacture or 

import quantities of a chemical that are 

more appropriately measured in grams 

(e.g., as impurities, contaminants, or 

byproducts, which are not expected to 

be released into the environment in 

significant amounts). 

The Agency intends to issue catch-up 

orders to manufacturers or importers 

who begin to manufacture or import an 

EDSP SDWA chemical within 15 years 

of the issuance of a SDWA/FFDCA test 

order. The EDSP SDWA chemical catchup order process will be similar to the 

catch-up order process described in the 

FIFRA/FFDCA policies and procedures 

(Ref. 1), except that EPA generally 

expects that the source of information 

for identifying such manufacturers will 

primarily come from the public, because 

there is no industrial chemical 

registration process comparable to the 

pesticide registration process that would 

provide a mechanism for EPA to 

independently identify such entities. A 

recipient of such catch-up orders would 

have the same options for compliance as 

an initial order recipient: independently 

generate the data or participate in the 

cost sharing by making a good faith offer 

to participate, if it wishes to rely on data 

developed or submitted by another 

recipient or consortium to satisfy its 

EDSP test order obligation. 

If, at the end of this process, all EDSP 

test order recipients have ceased to 

manufacture a SDWA chemical without 

submitting the required data, the 

Agency generally intends to treat the 

SDWA chemical as an ‘‘orphan.’’ 

B. How will recipients of orders on 

SDWA chemicals be notified? 

Order recipients will receive an EDSP 

test order in one of two ways: By 

registered mail or electronically. In 

addition to the EDSP test order, EPA 

will send each recipient a packet that 

contains the instructions, background 

materials, and sample forms needed to 

comply electronically with the EDSP 

test order via CDX or will provide 

directions as to the location of such 

materials in an electronic format. 

C. How will the public know who has 

received a test order on a SDWA 

chemical or who has supplied data? 

EPA intends to provide the list of all 

EDSP test order recipients on the 

Agency’s EDSP Web site (Ref. 4). EPA 

invites the submission of information 

(with proper substantiation) identifying 

additional entities—including entities 

who manufacture for export only—who 

should have received a test order. 

Commenters could either identify 

themselves or another person as 

additional candidates for the receipt of 

an EDSP test order. 

D. How will the Agency minimize 

duplicative testing? 

As described in greater detail in this 

unit, EPA generally intends to continue 

to rely on its existing procedures to 

minimize duplicative EDSP testing for 

SDWA chemicals, including continuing 

to allow companies to voluntarily 

develop data jointly, and, as described 

in Unit VI.G., continuing to apply the 

policies that facilitate joint data 

development, as well as to accept OSRI 

in satisfaction of the order. 

In addition, the Agency intends to 

provide the status of the EDSP test 

orders, including recipients’ responses, 

on the Agency’s EDSP Web site so that 

both order recipients and the public can 

determine the status of responses (see 

for example Ref. 18). EPA will make 

such information available to enable test 

order recipients to identify and join 

other order recipients to develop the 

data in response to the order, thereby 

helping to achieve EPA’s goals of 

minimizing duplicative testing and 

promoting fair and equitable sharing of 

EDSP test costs. 

E. What are the potential responses to 

test orders on SDWA chemicals? 

The options for responding to a 

SDWA/FFDCA test order are similar to 

those established in the FIFRA/FFDCA 

policies and procedures (Ref. 1), except 

that the option of exiting the pesticide 

market will not be available. The basis 

for a SDWA/FFDCA order is that a 

chemical may be found in sources of 

drinking water to which a substantial 

population may be exposed. Exiting any 

given market (e.g., the pesticide market) 

is not sufficient if the SDWA chemical 

is manufactured or imported for other 

uses because the chemical may still be 

found in sources of drinking water. If 

sufficient data on a SDWA chemical that 

is a pesticide is not generated in 

response to a FIFRA/FFDCA order (e.g., 

all FIFRA/FFDCA order recipients exit 

the pesticide market), EPA may issue a 

follow-up SDWA/FFDCA order for such 

mstockstill on DSK4VPTVN1PROD with NOTICES

35918 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

chemicals if they have non-pesticide 

uses. 

EDSP test order recipients provide 

their initial responses electronically 

referencing the options on a sample 

Initial Response Form for Individual 

Order Recipients (Initial Response 

Form) (Ref. 19). Response options that 

EPA anticipates including in SDWA/ 

FFDCA test orders are as follows: 

Option 1: Recipient indicates that it 

intends to generate data. If the EDSP 

test order recipient decides to generate 

new data for each test specified in the 

order, the recipient would then comply 

with the procedures prescribed in the 

EDSP test order. In general, this option 

would be identical to the option 

discussed in the FIFRA/FFDCA policies 

and procedures (Ref. 1). EPA has not 

identified any changes that would be 

necessary to accommodate SDWA 

chemicals. Data generated and 

submitted would need to comply with 

the existing requirements for Good 

Laboratory Practices (GLP), as 

applicable. GLPs have been set out both 

in FIFRA for pesticides in 40 CFR part 

160 and for TSCA chemicals in 40 CFR 

part 792. EDSP test order recipients 

would need to follow any appropriate 

GLPs, protocol requirements identified 

in the EDSP test order, and procedures 

described in EDSP test orders for 

submitting the data. 

Option 2: Recipient indicates that it is 

submitting or citing existing data or 

OSRI. The recipient would choose this 

option to indicate that it is submitting 

or citing existing data (including data 

previously submitted to the Agency) 

that it believes is relevant to one or 

more of the requests in the test order. 

The recipient’s initial response would 

include either the data or a reference to 

the data for each assay specified in the 

order. In submitting or citing existing 

data, the order recipient should follow, 

as appropriate, relevant format 

guidelines described in the EDSP test 

order and provide an explanation of the 

relevance of the data to the order, 

including, where appropriate, a cogent 

and complete rationale for why it 

believes the information is or is not 

sufficient to satisfy part or all of the Tier 

1 test order. 

Data compensation procedures may 

apply to data previously submitted to 

the Agency. If the data cited or 

submitted are from a study that was not 

conducted exactly as specified in the 

protocols referenced in the EDSP test 

order or in accordance with accepted 

scientific methodology or protocol, 

including but not limited to those 

presented in EPA’s harmonized test 

guideline compendium (Ref. 20), the 

recipient would also identify the 

deviations from the applicable 

protocol(s), along with an explanation 

for the deviations, including an 

explanation as to why, notwithstanding 

the deviations, the protocol used for 

developing the cited or submitted data 

should still be considered as providing 

an accepted scientific methodology or 

protocol, and any other information 

relevant to a decision to accept the data 

as satisfaction of the order. 

EPA would review any existing 

relevant information submitted or cited 

(including OSRI) to determine whether 

the information is acceptable (e.g., the 

study was not rejected by the Agency for 

any reason related to completeness or 

quality) and satisfies the order. 

Decisions about whether the 

information satisfies part or all of the 

Tier 1 test order will be based on WoE 

from all relevant information available. 

The Agency would notify the recipient 

of its determination. 

If the Agency determines that the 

information cited or submitted as part of 

the initial response received from an 

order recipient satisfies the Tier 1 test 

order the electronic Initial Response 

Form is the only response required. 

If, however, EPA determines that the 

information cited or submitted as part of 

the initial response is insufficient to 

satisfy the Tier 1 test order, in whole or 

in part, the recipient would still need to 

satisfy any order requirements EPA had 

determined had not been met. EPA 

intends to use a WoE approach as 

described in the EDSP WoE guidance 

document (Ref. 11) which takes into 

account data from the Tier 1 assays and 

any other scientifically relevant 

information available, to determine 

whether the chemical has the potential 

to interact with the endocrine system. 

Chemicals that go through Tier 1 

screening and are found to have the 

potential to interact with the estrogen, 

androgen, or thyroid hormone systems 

will proceed to the next stage of the 

EDSP where EPA will determine which, 

if any, of the Tier 2 tests are necessary. 

Option 3: Recipient indicates that it 

intends to enter (or offer to enter) into 

an agreement to form a consortium to 

provide the data. The recipient may 

choose to join or form a consortium to 

share the cost of producing the required 

data. All participants of the consortium 

must submit their own electronic Initial 

Response Form for Individual Order 

Recipients, providing the name of the 

party who will be submitting the data 

on the recipient’s behalf. 

Under this option, the designated lead 

for the consortium would complete their 

Initial Responses electronically 

(Consortium Response Form) (Ref. 21) 

for the consortium to provide the 

primary contact for the consortium, the 

list of participants, and an indication of 

the consortium’s planned response for 

each assay, along with documentation of 

its formation (such as a copy of the joint 

agreement or a written statement by all 

the parties that an agreement exists). 

The joint agreement to produce the data 

would not need to specify all of the 

terms of the final arrangement between 

the parties or the mechanism to resolve 

the terms. The designated lead for the 

consortium would be responsible for 

submitting the consortium’s initial 

response and accompanying 

information to EPA by the due date for 

the consortium’s response, consistent 

with any mailing instructions indicated 

in the EDSP test order. 

Once the consortium submits the data 

electronically and EPA has completed 

its initial review, EPA would notify the 

contact of the consortium indicating 

whether the order has been satisfied. If 

satisfied, such an action would satisfy 

EDSP test order obligations for each of 

the consortium participants. 

If the consortium fails to submit the 

data or meet the requirements of the 

order in a timely and adequate manner, 

each recipient would be subject to 

penalties of up to $37,500 per day, 

unless the recipient were to commit to 

submit, and then did submit, the 

required data by the dates originally 

specified in the order. The Agency has 

typically granted very few, if any, time 

extensions for the submission of EDSP 

data. 

The Agency intends to provide to 

every EDSP test order recipient a list of 

the other manufacturers and/or 

importers (to the extent permitted by 

confidentiality requirements) that have 

also received an EDSP order for the 

specified SDWA chemical. This list 

would be intended to help order 

recipients identify other companies 

with whom they could form agreements 

to develop data jointly, or otherwise 

collaborate on a response to satisfy the 

requirements in the order. If the identity 

of a company subject to the SDWA/ 

FFDCA test order is claimed as CBI, 

EPA intends to offer the company an 

opportunity to identify an agent who 

would act on their behalf in all matters 

relating to the EDSP program. For any 

company that chooses to designate an 

agent, the Agency intends to make the 

name of the agent (instead of the 

company) public by including it on the 

list of recipients of SDWA/FFDCA test 

orders. This name use would be similar 

to the process used for FIFRA/FFDCA 

test orders and presented in the FIFRA/ 

FFDCA policies and procedures (Ref. 1). 

If the identity of a company subject to 

the EDSP test order is claimed as CBI, 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35919 

and yet the company does not name an 

agent, that company’s ability to obtain 

data compensation from other parties 

(or rely on compensable data submitted 

by other parties) would likely be 

affected. EPA intends to make available 

the list of EDSP test order recipients on 

the Agency’s EDSP Web site (Ref. 4). 

EPA intends to update the list with 

subsequent publication(s) and posting(s) 

as appropriate. For example, the Agency 

intends to post the status of the EDSP 

test orders, including the recipient’s 

response, on the Agency’s EDSP Web 

site so that both EDSP test order 

recipients and the public can check on 

the status of responses to the EDSP test 

orders. This public listing is intended to 

also facilitate the formation of consortia 

to develop data jointly since recipients 

would know all other entities required 

to generate the same data. 

Option 4: Recipient claims that it is 

not subject to the EDSP test order. 

Under this option, a recipient would 

claim that it is not subject to the order 

because it does not manufacture or 

import the chemical identified for EDSP 

testing, or because it believes the order 

was otherwise erroneously sent. This 

option would be essentially the same as 

the option discussed in the original 

policies and procedures for 

manufacturers of inert ingredients. EPA 

has not identified any issues unique to 

SDWA chemicals that would warrant a 

change in policy on this point. An 

explanation of the basis for the claim, 

along with appropriate information to 

allow the Agency to substantiate the 

claim, would accompany the Initial 

Response. The Agency intends to 

evaluate the claim and respond to any 

request within 90 days of receipt. If EPA 

were unable to verify the claim, the 

original requirements and deadlines in 

the order would be expected to remain. 

If EPA were able to verify the claim, 

such a response would satisfy the order 

and no further response would be 

necessary. 

Option 5: Recipient intends to 

discontinue the manufacture or import 

of the chemical. Under this option, the 

recipient would indicate it has or is in 

the process of discontinuing all 

manufacture and import of the 

chemical. As noted in Unit V.A., in 

order to take advantage of this option, 

a recipient would need to also cease 

manufacture of the chemical, including 

for the purposes of export. In addition, 

the recipient would be required to 

provide an electronic initial response 

via CDX that includes a verifiable 

explanation and documentation 

supporting its claim. If EPA verifies the 

claim, the electronic Initial Response 

Form is all that would be required to 

satisfy the EDSP test order. If EPA could 

not verify the claim, the recipient’s 

obligation to comply with the EDSP test 

order would remain. 

Unlike the FIFRA/FFDCA policies 

and procedures (Ref. 1), which enable a 

manufacturer or importer of a pesticide 

inert ingredient to comply with the 

FIFRA/FFDCA test order by 

discontinuing the sale of the chemical 

into the pesticide market, SDWA/ 

FFDCA test orders cannot be satisfied in 

this manner. A chemical manufacturer 

or importer that receives a SDWA/ 

FFDCA test order would need to cease 

all manufacture and import of that 

chemical. Simply exiting the pesticide 

market would not address the 

chemical’s potential presence in 

‘‘sources of drinking water to which a 

substantial population may be exposed’’ 

and it would therefore be inappropriate 

to allow companies to satisfy a test 

order with such a response. 

Option 6: Recipient responds 

according to one of three other response 

options. As part of the Initial Response, 

a recipient may also ask EPA to 

reconsider some or all of the EDSP 

testing specified in the order if: 

a. The recipient can demonstrate 

(supported by appropriate data) that the 

chemical is an endocrine disruptor and 

that additional EDSP Tier 1 screening is 

unnecessary. 

b. The recipient can demonstrate 

(supported by appropriate data) that the 

chemical meets the standard for an 

exemption under FFDCA section 

408(p)(4) (i.e., ‘‘that the substance is not 

anticipated to produce any effect in 

humans similar to an effect produced by 

a naturally occurring estrogen’’). 

c. The chemical was used by EPA as 

a ‘‘positive control’’ to validate one or 

more of the screening assays. In the last 

data collection, chemicals used by EPA 

as a ‘‘positive control’’ to validate one 

or more of the screening assays were 

only required to submit the assays for 

which the chemical did not serve as a 

positive control (e.g., if the chemical 

served as a positive control in the 

validation of two assays, the EDSP test 

order recipient would not be required to 

generate additional data for those two 

assays). EPA generally expects that it 

would continue this policy. 

For more information on the response 

options discussed in this unit, see the 

FIFRA/FFDCA policies and procedures 

(Ref. 1). 

The Agency intends to make a 

determination on any claim and 

respond to the recipient within 90 days 

of receipt. If EPA cannot verify the 

claim, the original requirements and 

deadlines in the order would remain. If 

EPA were to verify the claim, EPA 

would consider the response to fully 

satisfy the order and no further response 

would be required. 

F. How to submit order responses and 

data electronically? 

EPA has developed an electronic 

submission system for data submitted in 

response to SDWA/FFDCA test orders 

following the general process 

established for TSCA Section 5 

Premanufacture Notices and for other 

TSCA reporting, including TSCA 

Section 8 CDR. The EDSP order 

electronic reporting system will allow 

order recipients to use the Agency’s 

CDX to respond to an order and to 

submit test data via the Internet. See 

http://www.epa.gov/cdx for additional 

information about CDX (Ref. 22). If not 

already registered with CDX, recipients 

will need to complete a simple 

registration process in order to use this 

system for electronic submissions of 

EDSP test order data, thereby 

establishing a secure log-on to CDX. 

Specific requirements associated with 

these EDSP test orders will be provided 

directly to the order recipients, and are 

expected to include: 

• Registration with CDX, resulting in 

the establishment of an electronic 

signature usable for electronically 

submitting EDSP test order responses. 

• Access to a web-based response 

form, including the ability to attach PDF 

files. 

• Encrypted submission to EPA via 

CDX. 

Each EDSP test order would contain 

specific, updated information regarding 

the most current process to use to 

respond to the EDSP test order. 

G. How will EPA facilitate joint data 

development and cost sharing for SDWA 

chemicals? 

As described in the FIFRA/FFDCA 

policies and procedures (Ref. 1), the 

Agency believes that FFDCA section 

408(p)(5) does not provide the authority 

to create requirements for joint data 

development, including a requirement 

to use binding arbitration to resolve 

disputes, as does FIFRA section 3. In 

EPA’s view, FFDCA section 408(p)(5)(B) 

merely establishes a qualified direction 

that the Agency ‘‘[t]o the extent 

practicable . . . minimize duplicative 

testing . . .’’ This, standing alone, does 

not create new authority to compel 

companies to use arbitration to resolve 

disputes arising from an effort to 

develop data jointly, nor does it even 

authorize EPA to impose a requirement 

for joint data development. Rather, EPA 

believes that this provision directs the 

Agency to create procedures that 

operate within the confines of existing 

mstockstill on DSK4VPTVN1PROD with NOTICES

35920 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

statutory authorities. While FFDCA 

section 408(p) does not allow EPA to 

impose requirements identical to those 

authorized by FIFRA section 3, EPA has 

the authority under FFDCA section 

408(p) to develop Agency procedures 

that would facilitate joint data 

generation and electronic submission. 

Specifically, the Agency has discretion 

to determine what actions constitute 

compliance with a FFDCA section 

408(p) test order, and EPA intends to 

apply this discretion in a manner that 

creates strong incentives for companies 

to voluntarily develop data jointly. 

Section 408(p) of FFDCA confers 

adequate discretion for EPA to consider 

whether a recipient has fulfilled its 

obligation to provide data when the 

recipient individually or jointly submits 

results from the required studies, or 

when EPA judges that it would be 

equitable to allow the recipient to rely 

on, or cite, results of studies submitted 

by another person. 

At the same time, however, each 

recipient of an order under FFDCA 

section 408(p) has a separate obligation 

to satisfy the Tier 1 test order that it 

received. EPA thinks that FFDCA 

section 408(p) confers adequate 

discretion to consider that a recipient 

has fulfilled its obligation to provide 

data when: 

• The recipient individually or jointly 

submits results from the required 

assays. 

• EPA judges that it would be 

equitable to allow the recipient to rely 

on, or cite, results of studies submitted 

by another person. 

The determination of whether it 

would be equitable to allow citation to 

another recipient’s data will be 

necessarily based on a case-by-case 

review of the specifics of the individual 

circumstances. However, the Agency 

believes that it would generally be 

equitable to allow a recipient of a 

FFDCA section 408(p) test order to rely 

on the results of studies submitted by 

another person where: 

• The data generator has given 

permission to the recipient to cite the 

results, or 

• Within a reasonable period after 

receiving the FFDCA section 408(p) test 

order, the recipient has made an offer to 

commence negotiations regarding the 

amount and terms of paying a 

reasonable share of the cost of testing; 

has included an offer to resolve any 

dispute over the recipients’ shares of the 

test costs by submitting the dispute to 

a neutral third party with authority to 

bind the parties (e.g., through binding 

arbitration); and, if arbitration is 

requested, participates in the arbitration 

proceeding and complies with the terms 

of any arbitration award. 

The Agency believes this approach to 

minimizing duplicative EDSP testing, 

which parallels that used under FIFRA 

section 3(c)(2)(B), provides all recipients 

of FFDCA section 408(p) test orders 

adequate incentives to develop data 

jointly. In the first instance, where the 

data generator had granted permission 

for another party to cite its data, the 

equities are clear, and EPA has no 

reason for refusing to allow it. In the 

second instance, where the data 

generator received an offer to commence 

negotiations regarding the amount and 

terms of compensation and to go to a 

neutral decisionmaker with authority to 

bind the parties failing successful 

negotiations, EPA believes that the 

company has demonstrated a good faith 

effort to develop data jointly, and 

consequently would typically consider 

that the order recipient had complied 

with the order. Based on EPA’s 

experience under FIFRA, there would 

be little or no reason for a data generator 

to decline such an offer. Moreover, if 

EPA did not adopt such an approach, 

the end result would effectively confer 

the sort of ‘‘exclusive use’’ property 

rights established under FIFRA section 

3(c)(1)(F), on a broad category of data, 

and EPA does not believe that FFDCA 

section 408(p)(5) creates such rights, or 

provides EPA with the authority to 

create such rights. These conditions 

would also apply to recipients of any 

‘‘catch-up’’ FFDCA § 408(p) orders, who 

enter the market after the data have been 

submitted. 

H. What procedures can EPA apply for 

handling CBI for SDWA chemicals? 

As stated in the FIFRA/FFDCA 

policies and procedures (Ref. 1), FFDCA 

does not authorize EPA to either create 

new rights or to modify existing rights 

to confidentiality, but directs the 

Agency to create procedures that 

operate within the existing confines of 

FIFRA, FOIA, and TSA. SDWA has no 

provisions that authorize EPA to extend 

protections for handling CBI beyond 

those established by TSA. Thus data 

submitted in response to SDWA/FFDCA 

orders would only be subject to the 

protections under FOIA and TSA, with 

the notable exception of data generated 

on pesticide chemicals. Manufacturers 

of a food use inert ingredient that is also 

identified as a SDWA chemical should 

generally expect to receive SDWA/ 

FFDCA test orders; however, all CBI and 

data compensation provisions 

established in FIFRA would still apply. 

In addition, under certain 

circumstances, data generated on nonfood use inert ingredients may be 

entitled to FIFRA CBI and data 

compensation protections. Test order 

recipients for the food use-inert, or a 

pesticide with a food tolerance or 

exemption, should consult the FIFRA/ 

FFDCA policies and procedures (Ref. 1) 

for a more detailed explanation of the 

FIFRA provisions that apply. 

The identities of chemicals on the 

non-confidential portion TSCA 

Inventory (i.e., the chemical identity of 

the chemical substance is publicly 

known), contained in health and safety 

data subject to TSCA may not be 

entitled to confidential treatment (Ref. 

23). In addition, because the chemical 

identity is public for all SDWA 

chemicals on the second EDSP chemical 

list, EPA expects that there would be no 

need to claim submitted information as 

confidential. EPA also believes that it 

would be particularly difficult to 

substantiate such a claim, given that the 

information would already be publicly 

available. 

As described in Unit V.E. under 

Option 3, when the identity of a 

company subject to the SDWA/FFDCA 

test order is claimed as CBI, EPA 

intends to offer the company an 

opportunity to identify an agent who 

would act on their behalf in all matters 

relating to EDSP. For any company that 

chooses to designate an agent, the 

Agency intends to make the name of the 

agent (instead of the company) public 

by including it on the list of recipients 

of SDWA/FFDCA test orders. 

I. What is the process for contesting a 

test order or consequences for failure to 

respond or comply with a test order? 

EPA generally intends to rely on the 

existing interpretations and policies 

relating to pre-enforcement challenges 

to and enforcement of a test order. Order 

recipients are encouraged to consult the 

FIFRA/FFDCA policies and procedures 

(Ref. 1) for further details on these 

policies. 

J. What is the informal administrative 

review procedure? 

EPA generally intends to continue to 

include the informal administrative 

review provisions in SDWA/FFDCA test 

orders by which recipients could raise 

any questions or challenges concerning 

the issuance of the order, that were 

included in the orders issued for the 

first list of chemicals. As explained in 

the FIFRA/FFDCA policies and 

procedures (Ref. 1), because the mere 

filing of the objection (or indeed, the 

filing of a judicial challenge) would not 

extend the deadline for submission of 

the studies, in order for this process to 

be completed in a timely fashion, EPA 

expects order recipients who file a 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35921 

challenge to present their objections 

with sufficient specificity and detail to 

allow the Agency to effectively evaluate 

the issue(s) presented. EPA would 

review the issues presented and respond 

within a reasonable amount of time. The 

Agency understands that it will need to 

respond to such objections within 

sufficient time for the order recipient to 

comply with the orders, or to pursue 

judicial review. 

K. What are the adverse effects reporting 

requirements? 

EPA is not modifying any of its 

existing reporting requirements or any 

of the policies with respect to how the 

adverse effects reporting requirements 

relate to EDSP data. 

Adverse effects reporting 

requirements for pesticide chemicals in 

registered products are established in 

FIFRA section 6(a)(2) and can be found 

in the FIFRA/FFDCA policies and 

procedures (Ref. 1). In addition to 

requirements under FIFRA, TSCA 

section 8(c) allows EPA to request that 

companies record, retain and/or report 

‘‘allegation of significant adverse 

reactions’’ to a chemical substance or 

mixture that the company produces, 

imports, processes or distributes (15 

U.S.C. 2607(c)). Additional information 

can be found in 40 CFR part 717. 

Chemical substance is defined in TSCA 

(15 U.S.C. 2602(2)). 

Under TSCA section 8(e), U.S. 

chemical manufacturers, importers, 

processors, and distributors are required 

to notify EPA within 30 days of new 

unpublished information regarding their 

chemical if the information may lead to 

a conclusion that the chemical poses 

substantial risk to human health or the 

environment (15 U.S.C. 2607(e)). 

‘‘Substantial risk’’ information is 

information that offers reasonable 

support for a conclusion that the subject 

chemical substance or mixture poses a 

substantial risk of injury to health or the 

environment. The information need not, 

and typically does not, establish 

conclusively that a substantial risk 

exists. 

Any information that has been 

previously submitted under FIFRA 

section 6(a)(2), TSCA section 8(c), or 

TSCA section 8(e), to the extent the 

EDSP test order recipient believes that 

it is responsive to the EDSP test order, 

need not be resubmitted to satisfy the 

FFDCA section 408(p) test orders. The 

EDSP test order recipient need only cite 

the previously submitted information in 

lieu of resubmission. 

VII. Statutory and Executive Order 

Reviews 

A. Regulatory Planning and Review 

Under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review’’ (58 FR 51735, October 4, 1993), 

this policy statement is not considered 

to be a ‘‘significant guidance document’’ 

under the terms of the Executive Order 

because this policy statement does not 

raise novel legacy or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. As 

indicated in this unit, this policy 

statement only makes a few 

modifications that are necessary to 

address procedural differences that 

apply to SDWA chemicals. 

B. Paperwork Reduction Act (PRA) 

The information collection 

requirements described in this 

document have been submitted to OMB 

for review under PRA, 44 U.S.C. 3501 et 

seq. Elsewhere in this Federal Register 

issue is a separate document prepared 

by EPA that announces the availability 

of the ICR document. The docket ID 

number for this ICR submission is EPA– 

HQ–OPPT–2013–0275. An Agency may 

not concur or sponsor, and a person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

The OMB control numbers are 

displayed either by publication in the 

Federal Register or by other appropriate 

means, such as on the related collection 

instrument or form, if applicable. The 

display of OMB control numbers in 

certain EPA regulations is consolidated 

in 40 CFR part 9. As a new ICR, the 

Agency does not yet have an OMB 

control number for this information 

collection activity. Once assigned, EPA 

will announce the OMB control number 

for this information collection in the 

Federal Register, and will add it to any 

related collection instruments or forms 

used. Burden is defined in 5 CFR 

1320.3(b). 

VIII. References 

As indicated under ADDRESSES, a 

docket has been established for this 

notice under docket ID number EPA– 

HQ–OPPT–2007–1080. The following is 

a listing of the documents that are 

specifically referenced in this action. 

The docket includes these documents 

and other information considered by 

EPA, including documents that are 

referenced within the documents that 

are included in the docket, even if the 

referenced document is not physically 

located in the docket. For assistance in 

locating these other documents, please 

consult the technical person listed 

under FOR FURTHER INFORMATION

CONTACT. 

1. EPA. Endocrine Disruptor Screening 

Program; Policies and Procedures for 

Initial Screening; Notice. Federal 

Register (74 FR 17560, April 15, 2009) 

(FRL–8399–9). 

2. EPA. Order Template: ‘‘FFDCA § 408(p) 

Order Template for SDWA § 1457 

Chemicals.’’ April 15, 2013. Available in 

Attachment C(3) to the ICR in Docket ID 

Number EPA–HQ–OPPT–2013–0275. 

3. U.S. Congress. House Resolution 2996, H. 

Rept. 111–180. 

4. EPA. Endocrine Disruptor Screening 

Program Web site at http://www.epa.gov/ 

endo. 

5. EPA. Endocrine Disruptor Screening 

Program; Draft Policies and Procedures 

for Screening Safe Drinking Water Act 

Chemicals; Notice. Federal Register (75 

FR 70558, November 17, 2010) (FRL– 

8848–9). 

6. EPA. Response-to-Comments Document for 

the Notice on the Endocrine Disruptor 

Screening Program’s Draft Policies and 

Procedures for Screening Safe Drinking 

Water Act Chemicals that published in 

the Federal Register on November 17, 

2010 at 75 FR 70558. March 7, 2013. 

7. EPA. Comment Response Document for the 

Second List of Chemicals and Substances 

for Tier 1 Screening under the Endocrine 

Disruptor Screening Program 

(Categorized Public Comments). 

February 1, 2013. Available in Docket ID 

Number EPA–HQ–OPPT–2009–0477. 

8. EPA. Electronic Reporting Under the Toxic 

Substances Control Act; Proposed rule. 

Federal Register (77 FR 22707, April 17, 

2012) (FRL–9337–5). 

9. EPA. TSCA section 8(e); Notification of 

Substantial Risk; Policy Clarification and 

Reporting Guidance. Federal Register 

(68 FR 33129, June 3, 2003) (FRL–7287– 

4). 

10. EPA. EPA’s Approach for Considering 

Other Scientifically Relevant Information 

(OSRI) under the Endocrine Disruptor 

Screening Program (EDSP). March 26, 

2009. Document ID Number EPA–HQ– 

OPPT–2007–1080–0032. 

11. EPA. Weight-of-Evidence: Evaluating 

Results of EDSP Tier 1 Screening to 

Identify the Need for Tier 2 Testing. 

September 14, 2011. Document ID 

Number EPA–HQ–OPPT–2010–0877– 

0021. 

12. EPA. Universe of Chemicals and General 

Validation Principles. November 2012. 

Available at http://www.epa.gov/endo/

pubs/edsp_chemical_universe_and_

general_validations_white_paper_11_

12.pdf. 

13. EPA. Response to Comments on the 

Public Review Draft of the Information 

Collection Request (ICR) entitled 

‘‘Addendum for the Second List of 

Chemicals; Tier 1 Screening of Certain 

Chemicals Under the Endocrine 

Disruptor Screening Program (EDSP).’’ 

Available in Docket ID Number EPA– 

HQ–OPPT–2013–0275. 

14. EPA. SAB. Review of the EPA’s Proposed 

mstockstill on DSK4VPTVN1PROD with NOTICES

35922 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

Environmental Endocrine Disruptor 

Screening Program; Review of the 

Endocrine Disruptor Screening Program 

by a Joint Subcommittee of the Science 

Advisory Board and Scientific Advisory 

Panel. July 1999. EPA publication 

number EPA–SAB–EC–99–013. 

Available at http://www.epa.gov/endo/

pubs/sab_sap_report.pdf. 

15. EPA. U.S. Environmental Protection 

Agency Endocrine Disruptor Screening 

Program Comprehensive Management 

Plan. June 2012. Available at http://

www.epa.gov/endo/pubs/EDSPcomprehensive-management-plan.pdf. 

16. EPA. At a Glance: Issuing EDSP Second 

List Orders. (March 28, 2013). 

17. EPA. Chemical Data Reporting Web site 

at http://www.epa.gov/oppt/cdr. 

18. EPA. Status of EDSP Orders/DCIs as of 

Wednesday, January 2, 2013. 

19. EPA. Sample Form: ‘‘FFDCA § 408(p) 

Order for SDWA § 1457 Chemicals— 

Initial Response Form for Individual 

Order Recipients’’ (EPA Form No. 6300– 

06). March 27, 2013. Available in 

Attachment D(3) to the ICR in Docket ID 

Number EPA–HQ–OPPT–2013–0275. 

20. EPA. OCSPP Harmonized Test Guidelines 

Web site at http://www.epa.gov/ocspp/

pubs/frs/home/testmeth.htm. 

21. EPA. Sample Form: ‘‘FFDCA § 408(p) 

Order for SDWA § 1457 Chemicals— 

Initial Response Form for Consortium’’ 

(EPA Form No. 6300–06–C). March 27, 

2013. Available in Attachment D(4) to 

the ICR in Docket ID Number EPA–HQ– 

OPPT–2013–0275. 

22. EPA. Central Data Exchange Web site at 

http://www.epa.gov/cdx. 

23. EPA. Claims of Confidentiality of Certain 

Chemical Identities Submitted under 

Section 8(e) of the Toxic Substances 

Control Act; Notice. Federal Register (75 

FR 3462, January 21, 2010) (FRL–8807– 

9). 

List of Subjects 

Environmental protection, Chemicals, 

Endocrine disruptors, Pesticides and 

pests, Safe drinking water, Reporting 

and recordkeeping. 

Dated: May 29, 2013. 

James Jones, 

Acting Assistant Administrator, Office of 

Chemical Safety and Pollution Prevention. 

[FR Doc. 2013–14228 Filed 6–13–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2009–0477; FRL–9375–8] 

Endocrine Disruptor Screening 

Program; Final Second List of 

Chemicals and Substances for Tier 1 

Screening 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This document announces the 

final second list of 109 chemicals 

identified for Tier 1 screening under the 

Endocrine Disruptor Screening Program 

(EDSP). The EDSP is established under 

section 408(p) of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), which 

requires EPA to develop a chemical 

screening program using appropriate 

validated test systems and other 

scientifically relevant information to 

determine whether certain substances 

may have hormonal effects. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Hannah 

Holsinger, Office of Water, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001 (MC–4607M); telephone 

number: (202) 564–0403, email address: 

holsinger.hannah@epa.gov, or Pat West, 

Office of Science Coordination and 

Policy, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001 (MC– 

7201M); telephone number: (202) 564– 

1656, email address: west.pat@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you produce, manufacture, 

use, or import chemicals (including 

pesticide chemicals) that may be found 

in sources of drinking water; if you 

manufacture or import chemicals that 

degrade to chemicals found in sources 

of drinking water; or if you are, or may 

otherwise be, involved in the testing of 

chemicals for potential endocrine 

effects. The following list of North 

American Industrial Classification 

System (NAICS) codes is not intended 

to be exhaustive, but rather provides a 

guide to help readers determine whether 

this document applies to them. 

Potentially affected entities may 

include: 

• Chemical manufacturers, importers 

and processors (NAICS code 325), e.g., 

persons who manufacture, import or 

process chemical substances. 

• Pesticide, fertilizer, and other 

agricultural chemical manufacturers 

(NAICS code 3253), e.g., persons who 

manufacture, import or process 

pesticide, fertilizer and agricultural 

chemicals. 

• Scientific research and 

development services (NAICS code 

5417), e.g., persons who conduct testing 

of chemical substances for endocrine 

effects. 

B. How can I get copies of this document 

and other related information? 

The docket for this action, identified 

by docket identification (ID) number 

EPA–HQ–OPPT–2009–0477, is available 

at http://www.regulations.gov or at the 

Office of Pollution Prevention and 

Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 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 telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http:// 

www.epa.gov/dockets. 

II. Background 

A. What action is the agency taking? 

This document announces the final 

second list of 109 chemicals identified 

for Tier 1 screening under the Endocrine 

Disruptor Screening Program (EDSP). 

The EDSP is established under section 

408(p) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), which requires 

EPA to develop a chemical screening 

program using appropriate validated test 

systems and other scientifically relevant 

information to determine whether 

certain substances may have hormonal 

effects. After considering comments 

received on the draft second list of 

chemicals and substances published in 

the Federal Register notice of November 

17, 2010 (75 FR 70248) (FRL–8848–7) 

(Ref. 1), EPA is announcing the final list 

of the second group of chemicals that 

will be subject to screening based on the 

approach described in the notice— 

‘‘Endocrine Disruptor Screening 

Program; Final Policies and Procedures 

for Screening Safe Drinking Water Act 

(SDWA) Chemicals,’’ published 

elsewhere in today’s Federal Register. 

The EDSP consists of a two-tiered 

approach to screen and test chemicals 

for potential endocrine disrupting 

effects. The purpose of Tier 1 screening 

is to identify substances that have the 

potential to interact with the endocrine 

system (specifically the estrogen, 

androgen, or thyroid hormone systems) 

using a battery of assays. Substances 

that have the potential to interact with 

estrogen, androgen or thyroid systems 

may proceed to Tier 2, which is 

designed to identify any adverse 

endocrine-related effects caused by the 

mstockstill on DSK4VPTVN1PROD with NOTICES