Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10833 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0176; FRL–10017–66] 

Oxalic Acid; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of oxalic acid on 

honey and honeycomb. This regulation 

eliminates the need to establish a 

maximum permissible level on these 

commodities for residues of oxalic acid. 

DATES: This regulation is effective 

February 23, 2021. Objections and 

requests for hearings must be received 

on or before April 26, 2021, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2020–0176, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. 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 OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues 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: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. 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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2020–1076 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before April 

26, 2021. Addresses for mail and hand 

delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2020–0176, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of September 

30, 2020 (85 FR 61682) (FRL–10014–74), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 0E8824) 

by Interregional Research Project 

Number 4 (IR–4), 500 College Road East, 

Suite 201W, Princeton, NJ 08540 as an 

agent for the U.S. Department of 

Agriculture, Agricultural Research 

Service (ARS), Bee Research Laboratory, 

10300 Baltimore Ave. Bldg. 306, BARCEast, Beltsville, MD 20705. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance in 

or on honey and honeycomb for 

residues of oxalic acid dihydrate. That 

document referenced a summary of the 

petition prepared by the petitioner, 

ARS, which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C) and (D), which requires 

10834 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue . . .’’, as 

well as consider other factors. 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and other nonoccupational exposures that occur as a 

result of use of the pesticide. 

III. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. The 

nature of the toxic effects caused by 

oxalic acid are discussed in this unit. 

Oxalic acid is ubiquitous in the 

environment being found naturally in 

many plants and vegetables, as well as 

in honey. Oxalic acid is commonly used 

as an analytical reagent in textile 

finishing, in metal, wood, or equipment 

cleaning, in bleaching straw and leather, 

in removing paint, varnish, rust, or ink 

stains, in dye manufacturing, in 

chemical synthesis, in the paper, 

ceramics, photographic, and rubber 

industries, as well as in vitro as a blood 

specimen anticoagulant in veterinary 

medicine. The available data indicate 

decreased body weight effects occuring 

only at high doses. Moreover, based on 

the literature and due to the lack of 

adverse effects associated with the long 

history of use in a number of 

manufacturing processes and goods, 

exposure to oxalic acid is unlikely to 

result in short-term, long-term, prenatal 

developmental, or mutagenic and/or 

genotoxic toxicological effects. A full 

discussion of the literature and 

background on the toxicological profile 

of oxalic acid can be found in docket 

number EPA–HQ–OPP–2020–0176 in 

the documents titled ‘‘Oxalic Acid. 

Label Amendment Regarding Use in 

Beehives with Honey Supers to Control 

Varroa Mites’’ and ‘‘Oxalic Acid. New 

Use in Beehives to control Varroa 

mites.’’ 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

Oxalic acid is ubiquitous in the 

environment being found naturally in 

many plants and vegetables, as well as 

in honey. Available studies and 

literature indicate that residues in or on 

honey from the proposed use will be 

insignificant and indistinguishable from 

background levels of oxalic acid, and 

due to the lack of toxicity, exposure is 

not expected to pose a risk. EPA had 

also considered the potential for 

aggregate exposure to oxalic acid 

residues in food and all other nonoccupational exposures, including 

drinking water (ground and surface) and 

other pesticide uses in gardens, lawns, 

and/or buildings (residential and other 

indoor uses). The proposed use does not 

change the previous assessment’s 

conclusions about drinking water and 

residential exposure. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found oxalic acid to 

share a common mechanism of toxicity 

with any other substances, and oxalic 

acid does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that oxalic acid does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at https:// 

www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

Based on the lack of toxicity and the 

fact that residues will be below and 

indistinguishable from naturally 

occurring oxalic acid, EPA concludes 

that there is a reasonable certainty that 

no harm to the general U.S. population 

or any population subgroup, including 

infants and children, will result from 

aggregate exposure when considering 

dietary exposure and all other nonoccupational sources of pesticide 

exposure. Accordingly, EPA finds that 

exempting residues of oxalic acid from 

the requirement of a tolerance will be 

safe. 

VII. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

VIII. Conclusion 

Therefore, an exemption is 

established for residues of oxalic acid in 

or on honey and honeycomb when 

applied to beehives. 

IX. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). This action 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501 et seq.), nor does 

it require any special considerations 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10835 

under FFDCA section 408(d), such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

X. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 23, 2020. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Add § 180.1381 to subpart D to read 

as follows: 

§ 180.1381 Oxalic Acid; exemption from 

the requirement of a tolerance. 

Residues of oxalic acid in or on honey 

and honeycomb are exempted from the 

requirement of a tolerance when oxalic 

acid is used as a miticide in honeybee 

hives. 

[FR Doc. 2021–03256 Filed 2–22–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 100 

RIN 0906–AB24 

National Vaccine Injury Compensation 

Program: Revisions to the Vaccine 

Injury Table; Delay of Effective Date 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: In accordance with the 

Presidential directive as expressed in 

the memorandum of January 20, 2021, 

from the Assistant to the President and 

Chief of Staff, entitled ‘‘Regulatory 

Freeze Pending Review,’’ this action 

delays until April 23, 2021, the effective 

date of the rule entitled ‘‘National 

Vaccine Injury Compensation Program: 

Revisions to the Vaccine Injury Table,’’ 

published in the Federal Register on 

January 21, 2021 (January 21, 2021 Final 

Rule). 

DATES: As of February 22, 2021, the 

effective date of the January 21, 2021 

Final Rule, published in the Federal 

Register at 86 FR 6249, is delayed for 60 

days, from February 22, 2021 to April 

23, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Please visit the National Vaccine Injury 

Compensation Program’s website, 

https://www.hrsa.gov/ 

vaccinecompensation/, or contact 

Tamara Overby, Acting Director, 

Division of Injury Compensation 

Programs, Healthcare Systems Bureau, 

HRSA, Room 08N146B, 5600 Fishers 

Lane, Rockville, MD 20857; by email at 

vaccinecompensation@hrsa.gov; or by 

telephone at (855) 266–2427. 

SUPPLEMENTARY INFORMATION: 

I. Background 

HHS published a notice of proposed 

rulemaking on July 20, 2020 (85 FR 

43794), and a final rule on January 21, 

2021 (86 FR 6249). The January 20, 2021 

Final Rule amended the provisions of 42 

CFR 100.3 by removing Shoulder Injury 

Related to Vaccine Administration 

(SIRVA), vasovagal syncope, and Item 

XVII from the Vaccine Injury Table. The 

January 20, 2021 memorandum from the 

Assistant to the President and Chief of 

Staff, entitled ‘‘Regulatory Freeze 

Pending Review,’’ instructed Federal 

agencies to consider delaying the 

effective date of rules published in the 

Federal Register, but which have not 

yet taken effect, for a period of 60 days 

so that the new Administration may 

review recently published rules for ‘‘any 

questions of fact, law, and policy the 

rule may raise.’’ The memorandum 

notes certain exceptions that do not 

apply here. On January 20, 2021, the 

Office of Management and Budget 

(OMB) also published OMB 

Memorandum M–21–14, 

Implementation of Memorandum 

Concerning Regulatory Freeze Pending 

Review, which provides guidance 

regarding the Regulatory Freeze 

Memorandum. See OMB M–21–14, 

Implementation of Memorandum 

Concerning Regulatory Freeze Pending 

Review, https://www.whitehouse.gov/ 

wp-content/uploads/2021/01/M-21-14- 

Regulatory-Review.pdf. OMB M–21–14 

explains that pursuant to the Regulatory 

Freeze Memorandum, agencies ‘‘should 

consider postponing the effective dates 

for 60 days and reopening the 

rulemaking process’’ for ‘‘rules that have 

not yet taken effect and about which 

questions involving law, fact, or policy 

have been raised.’’ Id. 

On February 12, 2021, HHS published 

a notice of proposed rulemaking, 

proposing, after a brief public comment 

period, to delay the effective date of the 

January 21, 2021 Final Rule for 60 days, 

from February 22, 2021, to April 23, 

2021. HHS did so to determine whether 

the January 21, 2021 Final Rule’s 

promulgation raises any legal issues, 

including but not limited to (1) whether 

the Advisory Commission on Childhood 

Vaccines (ACCV) was properly notified 

of the proposed rule pursuant to 42