[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Proposed Rules]
[Pages 27546-27550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09998]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2021-0174; FRL-10023-55]


Petition for Rulemaking Under TSCA; Reasons for Agency Response; 
Denial of Requested Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition for rulemaking; denial; reasons for Agency response.

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SUMMARY: This document announces the availability of EPA's response to 
a portion of the petition it received February 8, 2021, from People for 
Protecting Peace River, Center for Biological Diversity, and 16 other 
organizations. While the petition requested three actions related to 
TSCA, EPA has determined that only one of those actions is an 
appropriate request: A request to issue a test rule under TSCA 
requiring testing of phosphogypsum and process wastewater from 
phosphoric acid production. EPA is treating the other portions of the 
petition involving TSCA as a petition under the Administrative 
Procedure Act (APA); those other portions request EPA to initiate the 
prioritization process for designating phosphogypsum and process 
wastewater as high-priority substances for risk evaluation, and to make 
a determination by rule under TSCA that the use of phosphogypsum in 
road construction is a significant new use. Therefore, this document 
does not provide EPA's response to these two TSCA-requested actions. 
Also, this document does not address the petitioners' requests under 
the Resource Conservation and Recovery Act (RCRA). After careful 
consideration, EPA has denied the TSCA section 21 portion of the 
petition for the reasons set forth in this document.

DATES: EPA's response to this TSCA section 21 petition was signed May 
5, 2021.

ADDRESSES: The docket for this TSCA section 21 petition, identified by 
docket identification (ID) number EPA-HQ-OPPT-2021-0174, 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), West William Jefferson Clinton 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Public Reading Room are closed to visitors 
with limited exceptions. The EPA/DC staff continue to provide remote 
customer service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Brooke Porter, Existing Chemicals Risk Management Division (7404T), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-6388; email address: porter.brooke@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: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who manufacture (including 
import), distribute in commerce, process, use, or dispose of 
phosphogypsum and process wastewater. Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA 
to initiate a proceeding for the issuance, amendment, or repeal of a 
rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA 
sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth 
the facts which it is claimed establish that it is necessary to 
initiate the action requested. EPA is required to grant or deny the 
petition within 90 days of its filing. If EPA grants the petition, the 
Agency must promptly commence an appropriate proceeding. If EPA denies 
the petition, the Agency must publish its reasons for the denial in the 
Federal Register. A petitioner may commence a civil action in a U.S. 
district court seeking to compel initiation of the requested proceeding 
within 60 days of a denial or, if EPA does not issue a decision, within 
60 days of the expiration of the 90-day period.

C. What criteria apply to a decision on this TSCA section 21 petition?

1. Legal Standard Regarding TSCA Section 21 Petitions
    TSCA section 21(b)(1) requires that the petition ``set forth the 
facts which it is claimed establish that it is necessary'' to initiate 
the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 
implicitly incorporates the statutory standards that apply to the 
requested actions. Accordingly, EPA has relied on the standards in TSCA 
section 21 and in the provisions under which actions have been 
requested in evaluating this TSCA section 21 petition.
2. Legal Standard Regarding TSCA Section 4(a)(1)(A)(i)
    EPA must make several findings in order to require testing under 
TSCA section 4(a)(1)(A)(i) through a rule or order. EPA must find that 
the manufacture, distribution in commerce, processing, use, or disposal 
of a chemical substance or mixture, or that any combination of such 
activities, may present an unreasonable risk of injury to health or the 
environment; that information and experience are insufficient to 
reasonably determine or predict the effects of such activity or 
activities on health or the environment; and that testing of the 
chemical substance or mixture is necessary to develop the missing 
information. 15 U.S.C. 2603(a)(1)(A)(i).
3. Legal Standard Regarding TSCA Section 4(a)(1)(A)(ii)
    EPA must make several findings in order to require testing under 
TSCA section 4(a)(1)(A)(ii) through a rule or order. EPA must find that 
the chemical substance or mixture is or will be produced in substantial 
quantities, and it enters or may reasonably be anticipated to enter the 
environment in substantial quantities or there is or may be significant 
or substantial human exposure to such substance or mixture; that 
information and experience are insufficient to reasonably determine or 
predict the effects of the manufacture, distribution in commerce, 
processing, use, and/or disposal of the chemical substance or mixture 
on health or the environment; and that testing of the

[[Page 27547]]

chemical substance or mixture is necessary to develop the missing 
information. 15 U.S.C. 2603(a)(1)(A)(ii).
4. Legal Standard Regarding TSCA Section 26
    TSCA section 26(h) requires EPA, in carrying out TSCA sections 4, 
5, and 6, to make science-based decisions using ``scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, or models, employed in a manner consistent with the best 
available science,'' while also taking into account other 
considerations, including the relevance of information and any 
uncertainties. 15 U.S.C. 2625(h). TSCA section 26(i) requires that 
decisions under TSCA sections 4, 5, and 6 be ``based on the weight of 
scientific evidence.'' 15 U.S.C. 2625(i). TSCA section 26(k) requires 
that EPA consider information that is reasonably available in carrying 
out TSCA sections 4, 5, and 6. 15 U.S.C. 2625(k).
5. Legal Standard Regarding Mixtures Under TSCA Section 4(a)(1)(B) and 
Section 21(b)(4).
    In the case of a mixture, per TSCA section 4(a)(1)(B), EPA must 
also find that the effects which the mixture's manufacture, 
distribution in commerce, processing, use, or disposal, or any 
combination of such activities, may have on health or the environment 
may not be reasonably and more efficiently determined or predicted by 
testing the chemical substances which comprise the mixture. 15 U.S.C. 
2603(a)(1)(B). In addition, TSCA section 21 establishes standards a 
court must use to decide whether to order EPA to initiate rulemaking in 
the event of a lawsuit filed by the petitioner after denial of a TSCA 
section 21 petition. 15 U.S.C. 2620(b)(4)(B). EPA believes TSCA section 
21(b)(4) does not provide for judicial review of a petition to 
promulgate a test rule for mixtures. TSCA section 21(b)(4)(B)(i) 
specifies that the court's review pertains to application of the TSCA 
section 4 factors to chemical substances. Moreover, TSCA section 
21(b)(4)(B)(i) does not contain the additional finding that TSCA 
section 4 requires for issuing a test rule for mixtures (that the 
effect may not be reasonably and more efficiently determined or 
predicted by testing the chemical components). Congress left the 
complex issues associated with the testing of mixtures to the 
Administrator's discretion.

II. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On February 8, 2021, the People for Protecting Peace River, 
Atchafalaya Basinkeeper, Bayou City Waterkeeper, Calusa Waterkeeper, 
Center for Biological Diversity, Cherokee Concerned Citizens, Healthy 
Gulf, ManaSota-88, Our Santa Fe River, RISE St. James, Sierra Club's 
Florida and Delta chapters, Suncoast Waterkeeper, Suwanee Riverkeeper, 
Tampa Bay Waterkeeper, Waterkeeper Alliance, Waterkeepers Florida, and 
WWALS Watershed Coalition (the petitioners) requested EPA to take 
several actions under section 7004(a) of RCRA; section 21 of TSCA; and 
section 553 of the APA related to phosphogypsum and process wastewater 
from phosphoric acid production (process wastewater). With respect to 
TSCA, the petition asks EPA to (1) initiate the prioritization process 
for designating phosphogypsum and process wastewater as high-priority 
substances for risk evaluation under TSCA section 6(b)(1)(B)(i), (2) 
issue a test rule under TSCA section 4(a)(1)(A) requiring phosphogypsum 
and process wastewater manufacturers to develop information with 
respect to health and environmental effects relevant to a determination 
that the disposal of these chemical substances does or does not present 
an unreasonable risk of injury to health or the environment, and (3) 
make a determination by rule under TSCA section 5(a) that the use of 
phosphogypsum in road construction is a significant new use. This 
Federal Register document specifically addresses the petitioners' TSCA 
section 21 petition, requesting EPA to issue a test rule under TSCA 
section 4(a)(1)(A). As described in Unit II.A.1 and II.A.2, this 
Federal Register document does not address the TSCA-requested actions 
which cannot be addressed under TSCA section 21 (i.e., action under 
TSCA section 6(b)(1)(B)(i) and section 5(a)), and EPA will consider 
taking such action in response to those requests, as appropriate, under 
the APA. This Federal Register document also does not address the 
petitioners' requests under section 7004(a) of RCRA.
1. Request for Prioritization Under TSCA Section 6 and Related Testing 
Under TSCA section 4(a)(2)(B)
    With respect to actions under section 6 of TSCA, TSCA section 21 
provides only for the submission of a petition seeking the initiation 
of a proceeding for the issuance, amendment, or repeal of a rule under 
TSCA section 6(a). Prioritization under TSCA section 6(b) is distinct 
from rulemaking under TSCA section 6(a). Because TSCA section 21 does 
not provide an avenue for petitioners to request the initiation of the 
prioritization process for phosphogypsum and process wastewater, EPA is 
treating this portion of the request as a petition for action under the 
APA.
    Petitioners also assert that ``should EPA initiate prioritization 
but find that the development of new information is necessary to 
finalize a prioritization decision for phosphogypsum and process 
wastewater, EPA should exercise its authority under section 4(a)(2)(B) 
to obtain that information and establish priority'' (Ref. 1, page 41). 
Because EPA is not addressing the request for prioritization as part of 
this petition response and has not otherwise initiated prioritization 
on phosphogypsum or process wastewater, the Agency is not in a position 
to exercise its authority under TSCA section 4(a)(2)(B) in the manner 
and for the reason described by petitioners.
2. Request for Significant New Use Rule Under TSCA Section 5
    TSCA section 21 does not provide for the submission of a petition 
seeking the initiation of a rule under TSCA section 5. Significant new 
use rules are issued under the authority of TSCA section 5(a)(2). Since 
TSCA section 21 does not provide an avenue for petitioners to request 
the initiation of a proceeding to make a determination by rule under 
TSCA section 5(a), EPA is treating this portion of the request as a 
petition for action under the APA.
3. Request for Issuance of a Test Rule Under TSCA Section 4(a)(1)(A)
    TSCA section 21 does provide for the submission of a petition 
seeking issuance of a test rule under TSCA section 4(a)(1)(A). 
Therefore, this Federal Register document specifically addresses the 
only request permissible under TSCA section 21, requesting EPA to issue 
a test rule under TSCA section 4(a)(1)(A).
4. Request Under RCRA Section 7004(a)
    This Federal Register document does not address the petitioners' 
requests under section 7004(a) of RCRA.
5. Request Under APA Section 553(e)
    This Federal Register document does not address the petitioners' 
requests under section 553(e) of the APA.

B. What support did the petitioners offer?

    The petitioners are not clear as to the provision of TSCA section 
4(a)(1)(A)

[[Page 27548]]

under which they are seeking a test rule. On pages 13 and 14 of the 
petition, for example, petitioners list the criteria to evaluate the 
request for testing under TSCA section 4(a)(1)(A)(i). However, in 
addition, the petition also includes reference to TSCA section 
4(a)(1)(A)(ii). Because the petitioners were not clear whether they 
were seeking testing under TSCA section 4(a)(1)(A)(i) or 
4(a)(1)(A)(ii), EPA considered the criteria in both sections in 
evaluating the petition. Additionally, because petitioners did not 
indicate whether the requested testing would pertain to mixtures or to 
individual chemical substances within a mixture, EPA considered both in 
evaluating the petition.
1. May Present an Unreasonable Risk of Injury to Health or the 
Environment or Produced in Substantial Quantities
    The petitioners claim that phosphogypsum and process wastewater 
located across the United States may present an unreasonable risk of 
injury to human health and the environment under TSCA section 
4(a)(1)(A)(i)(I). The petitioners claim that in EPA's 1991 regulatory 
determination under the Bevill Amendment to RCRA (section 3001(b)(3)(A) 
of RCRA), regarding the exemption of processing ores and minerals, 
including phosphate rock, EPA indicated that phosphogypsum and process 
wastewater were more appropriate to address under a TSCA regulatory 
program. The petitioners make a general assertion that ``EPA's 
investigation of a TSCA regulatory program to manage phosphogypsum and 
process wastewater means these substances not only may, but do, pose an 
unreasonable risk of injury to human health and the environment'' (Ref. 
1, page 40). The petitioners point to the following studies and contend 
that worker exposure at phosphate fertilizer plants is associated with 
adverse health effects, however, an exposure-response relationship 
could not be established in these studies:
     Yiin, JH et al., 2016 (Ref. 2); and
     Kim, Kwang Po et al., 2006 (Ref. 3).
    In addition, petitioners include information regarding the toxicity 
of several chemical substances they indicate are ``phosphogypsum 
constituents'' (arsenic, lead, nickel, cadmium, chromium, silver, 
antimony, copper, mercury, and thallium), as well as information on 
radionuclides (uranium, thorium, and radium) (Ref. 1, pages 19-23).
    As support for the claim that phosphogypsum and process wastewater 
are produced in substantial quantities under TSCA section 
4(a)(1)(A)(ii)(I), petitioners provide information about the size of 
phosphogypsum stacks, the amount of phosphogypsum produced annually, 
and the volume of process wastewater that can be stored in stacks (Ref. 
1). Regarding production in substantial quantities, petitioners point 
to an EPA web page indicating that phosphogypsum is produced in 
quantities of 5.2 tons for every ton of phosphoric acid produced (Ref. 
4). In addition, petitioners cite to information indicating that 
approximately 46 million tons of phosphogypsum are created in the 
United States annually (Ref. 5).
2. Insufficient Information and Experience
    Without providing supporting rationale, the petitioners assert that 
updated information is needed, including:
     Information on ``population-level exposure risks'' for 
radionuclides and radon emissions for phosphogypsum stacks; and
     Information on the number and size of the phosphogypsum 
stacks.
    The petitioners also state that the majority of the available 
phosphogypsum and process wastewater research is focused on potential 
commercial uses, rather than toxicity and other health and 
environmental effects relevant to an unreasonable risk finding (Ref. 1, 
page 40).
3. Testing of Such Substance or Mixture With Respect to Such Effects Is 
Necessary To Develop Such Information
    The petitioners claim that a TSCA section 4 ``testing rule is 
necessary to fill gaps in current science and to better inform a future 
risk evaluation,'' citing the need for updated information on 
``population-level exposure risks'' for radionuclide and radon 
emissions for phosphogypsum stack systems since the population around 
each phosphogypsum stack has likely increased (Ref. 1, page 40). The 
petitioners also claim it is necessary to update toxicity information 
using the Toxicity Characteristic Leaching Procedure (TCLP) method 
(Ref. 1, page 40). The petitioners provide no further information 
identifying specific gaps in the TCLP information already available, or 
why additional testing is necessary under TSCA section 4(a)(1)(A).

III. Disposition of TSCA Section 21 Portion of the Petition

A. What is EPA's response?

    After careful consideration, EPA has denied the TSCA section 21 
portion of the petition. A copy of the Agency's response, which 
consists of the letter to the petitioners and this document, is posted 
on the EPA petition website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tscasection-21#reporting. The response, 
the petition (Ref. 1), and other information is available in the docket 
for this TSCA section 21 petition (see ADDRESSES).

B. What was EPA's reason for this response to the request for testing 
under TSCA section 4?

    TSCA section 21 does provide for the submission of a petition 
seeking the initiation of a proceeding for the issuance of a rule under 
TSCA section 4. The petition must ``set forth the facts which it is 
claimed establish that it is necessary to issue'' the requested rule. 
15 U.S.C. 2620(b)(1). When determining whether the petition meets that 
burden, EPA will consider whether the manufacture, distribution in 
commerce, processing, use, or disposal of a chemical substance or 
mixture, or any combination of such activities, may present an 
unreasonable risk of injury to health or the environment under TSCA 
section 4(a)(1)(A)(i)(I), or whether the chemical substance or mixture 
is or will be produced in substantial quantities, and it enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities or there is or may be significant or substantial human 
exposure to such substance or mixture under TSCA section 
4(a)(1)(A)(ii)(I). In addition, EPA will consider whether ``information 
available to the Administrator is insufficient to permit a reasoned 
evaluation of the health and environmental effects of the chemical 
substance or mixture.'' 15 U.S.C. 2620(b)(4)(B)(i)(I) (see also 15 
U.S.C. 2603(a)(1)). Furthermore, EPA's decision to grant a petition for 
the promulgation of a TSCA section 4 rule requires a finding that 
``testing of such substance or mixture with respect to such effects is 
necessary to develop such information.'' 15 U.S.C. 2603(a)(1). In the 
case of a mixture, the petitioners must set forth facts to establish 
that the effects of the mixture would not be ``reasonably and more 
efficiently determined or predicted by testing the chemical substances 
which comprise the mixture.'' 15 U.S.C. 2603(a)(1).
    EPA evaluated the information presented or referenced in the 
petition

[[Page 27549]]

and considered that information in the context of the applicable 
authorities and requirements of TSCA sections 4, 21, and 26. 
Notwithstanding that the burden is on the petitioners to present ``the 
facts which it is claimed establish that it is necessary'' for EPA to 
initiate the rule or issue the order sought, EPA nonetheless also 
considered relevant information that was reasonably available to the 
Agency during the 90-day petition review period. As detailed in Unit 
III.B.2 and III.B.3, EPA finds that the petitioners have not met their 
burden as defined in TSCA sections 4(a)(1)(A) and 21(b)(1) because the 
petitioners have not provided the facts necessary for the Agency to 
determine for phosphogypsum and process wastewater that existing 
information and experience are insufficient and testing with respect to 
such effects is necessary to develop such information. These 
deficiencies, among other findings, are detailed in this document.
1. May Present Unreasonable Risk of Injury to Health or the Environment 
or Produced in Substantial Quantities
    EPA is not opining on the sufficiency of the information presented 
for purposes of determining whether phosphogypsum or process wastewater 
may present unreasonable risk because the Agency finds that petitioners 
have not provided the facts necessary for the Agency to determine that 
existing information and experience are insufficient and testing with 
respect to such effects is necessary to develop such information, as 
described in more detail below. However, EPA agrees that phosphogypsum 
and process wastewater are or will be produced in substantial 
quantities under TSCA 4(a)(1)(A)(ii)(I).
2. Insufficient Information and Experience
    The petition does not set forth the facts necessary to demonstrate 
that there is ``insufficient information and experience'' on which the 
effects of phosphogypsum and process wastewater on health or the 
environment can reasonably be determined or predicted. The petitioners 
only claim that updated toxicity information using the TCLP method is 
necessary and assert that information available is from an outdated 
``Extraction Procedure.'' However, EPA has found that there are TCLP 
data related to phosphogypsum and process wastewater available in the 
public domain (Ref. 6). The petitioners failed to present facts 
indicating the nature and extent of existing TCLP data and articulate 
why this data is insufficient. The petitioners do not provide an 
assessment of existing data to support a finding of insufficient 
information and experience. The petitioners present no evidence that 
they undertook efforts such as a literature search of publicly 
available information, an analysis and characterization of the results 
of such a literature search, or an inventory of information they claim 
is missing from the public domain.
    Extensive information on the heavy metal chemical substances 
contained in phosphogypsum and process wastewater is readily available. 
For example, EPA has published Integrated Risk Information System 
(IRIS) assessments, which review existing information and characterize 
the hazards of chemicals, that are available for all of the heavy 
metals mentioned in the petition, as well as uranium (Ref. 7). 
Furthermore, the Agency for Toxic Substances and Disease Registry 
(ATSDR) has published Toxicological Profiles, which characterize the 
toxicologic and adverse health effects information for hazardous 
substances, for all of the metals, as well as for radon and the 
radionuclides referenced in the petition (Ref. 8). The petitioners make 
no mention of the IRIS assessments, nor have they provided the facts 
necessary to show that this extensive body of existing information on 
toxicological effects, including the ATSDR Toxicological Profiles cited 
in the petition, is insufficient. TSCA section 21 requires the 
petitioner, not EPA, to ``set forth the facts which it is claimed 
establish that it is necessary to issue, amend, or repeal a rule under 
TSCA sections 4, 6, or 8, or an order under TSCA sections 4 or 5(e).'' 
15 U.S.C. 2620. Therefore, petitioners have failed to meet their 
burden.
3. Testing of Such Substance or Mixture With Respect to Such Effects Is 
Necessary To Develop Such Information
    The petition did not include any data, information, or analysis 
related to the need for testing of phosphogypsum and process wastewater 
or for the chemical substances, including the heavy metals and 
radionuclides contained in phosphogypsum and process wastewater. A 
petition without such information is facially incomplete because it 
fails to provide minimum factual information for EPA to make the 
threshold findings needed to respond to and act on the petition as 
contemplated by TSCA section 21. Even if the petitioners had 
successfully demonstrated the insufficiency of existing information, 
they still failed to demonstrate that testing of phosphogypsum and 
process wastewater is needed to develop the necessary information that 
they claim does not exist. Importantly, the petitioners provided no 
information regarding how testing by manufacturers of phosphogypsum and 
process wastewater would provide the sort of health and environmental 
effects data that petitioners believe is necessary. The petitioners 
could have presented information about the types of tests that could be 
conducted, including some analysis of the methods that could be used to 
identify the data or information submitted or used, hazard thresholds 
recommended, and exposure estimates. Beyond an assertion that TCLP data 
is not available, the petitioners did not include any information on 
what type of testing they claim is needed.
4. Testing as a Mixture
    Petitioners do not indicate whether the requested testing would 
pertain to mixtures or to individual chemical substances within a 
mixture. With regard to testing phosphogypsum and process wastewater as 
a mixture, petitioners have not set forth facts sufficient to support 
the required finding for mixtures under TSCA section 4(a)(1): That the 
effects of phosphogypsum and process wastewater would not be 
``reasonably and more efficiently determined or predicted by testing 
the chemical substances which comprise the mixture.'' 15 U.S.C. 
2603(a)(1). EPA has broad discretion to make this finding, and although 
petitioners did not specify whether their request was for testing of 
phosphogypsum and process wastewater as a mixture, EPA does not, at 
this time, believe this finding is warranted.
5. Environmental Justice Considerations
    Petitioners express environmental justice concerns and include 
examples of a phosphogypsum and process wastewater facility near a 
historic Black neighborhood, and another facility in a region of 
Louisiana which they state has environmental justice concerns related 
to impacts from a variety of industrial activities (Ref. 1, pages 36-
38).
    As a general matter, EPA shares the petitioners' concerns regarding 
the potential for disproportionate impacts in communities with 
environmental justice concerns. However, petitioners must set forth the 
facts which it is claimed establish that it is necessary to issue a 
rule or order requiring testing under TSCA section 4(a)(1)(A). As 
petitioners have not set forth facts sufficient for EPA to make these 
findings, EPA is not able to issue a test

[[Page 27550]]

rule under TSCA section 4 in response to this TSCA section 21 petition.
6. What were EPA's conclusions?
    EPA denied the request to initiate a proceeding for the issuance of 
a rule under TSCA section 4 because the TSCA section 21 petition does 
not set forth the facts establishing that it is necessary for the 
Agency to issue such a rule. In particular, the petition does not 
demonstrate that existing information and experience on the effects of 
phosphogypsum and process wastewater are insufficient or that testing 
of phosphogypsum and process wastewater with respect to such effects is 
necessary to develop such information. Therefore, the petitioners have 
not demonstrated that the rule they requested is necessary.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. 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. Curran, Rachael, People for Protecting Peace River, and Lopez, 
Jaclyn, Center for Biological Diversity to the Administrator of the 
Environmental Protection Agency. Re: Petition for Rulemaking 
Pursuant to Section 7004(a) of the Resource Conservation and 
Recovery Act; Section 21 of the Toxic Substances Control Act; and 
Section 553 of the Administrative Procedure Act Concerning the 
Regulation of Phosphogypsum and Process Wastewater from Phosphoric 
Acid Production. Received February 8, 2021.
2. Yiin, JH et al. A study update of mortality in workers at a 
phosphate fertilizer production facility. American Journal of 
Industrial Medicine 59(1):12-22. January 2016. https://doi.org/10.1002/ajim.22542.
3. Kim, Kwang Po et al. Characterization of Radioactive Aerosols in 
Florida Phosphate Processing Facilities. Aerosol Science and 
Technology 40(6):410-421. February 2006. https://doi.org/10.1080/02786820600643313.
4. EPA. TENORM: Fertilizer and Fertilizer Production Wastes. April 
7, 2021. https://www.epa.gov/radiation/tenorm-fertilizer-and-fertilizer-production-wastes.
5. The Fertilizer Institute. Revised Request for Approval of 
Additional Uses of Phosphogypsum Pursuant to 40 CFR 61.206. April 
2020. https://www.epa.gov/sites/production/files/2020-10/documents/4-7-2020_pg_petition.pdf.
6. EPA. Mosaic Fertilizer, LLC Settlement. September 16, 2020. 
https://www.epa.gov/enforcement/mosaic-fertilizer-llc-settlement.
7. EPA. Integrated Risk Information System. March 26, 2021. https://www.epa.gov/iris.
8. Agency for Toxic Substances and Disease Registry. March 16, 2021. 
https://www.atsdr.cdc.gov/toxprofiledocs/index.html.

    Authority: 15 U.S.C. 2601 et seq.

Michal Freedhoff,
Principal Deputy Assistant Administrator, Office of Chemical Safety and 
Pollution Prevention.
[FR Doc. 2021-09998 Filed 5-20-21; 8:45 am]
BILLING CODE 6560-50-P


