Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 37989 

2Naito, K., M. Kusaba, N. Shikazono, T. Takano, 

A. Tanaka, T. Tanisaka, and M. Nishimura (2005). 

Transmissible and nontransmissible mutations 

induced by irradiating Arabidopsis thaliana pollen 

with gamma-rays and carbon ions. Genetics, 169, 

881–889. 3 Kazama, Y., K. Ishii, T. Hirano, T. Wakana, M. 

Yamada, S. Ohbu, and T. Abe (2017). Different 

mutational function of low- and high-linear energy 

transfer heavy-ion irradiation demonstrated by 

whole-genome resequencing of Arabidopsis 

mutants. Plant J. 92, 1020–1030. 4Men, A.E., T.S. Laniya, I.R. Searle, I. IturbeOrmaetxe, I. Gresshoff, Q. Jiang, B.J. Carroll, and 

P.M. Gresshoff (2002). Fast Neutron Mutagenesis of 

Soybean (Glycine soja L.) Produces a 

Supernodulating Mutant Containing a Large 

Deletion in Linkage Group H. Genome Letters 3: 

147–155. 

5Sears, E.A. (1977). An induced mutant with 

homoeologous pairing in common wheat. Canadian 

J of Genetics and Cytology 19: 585–593. 

modification described in § 340.1(b)(1), 

but enable a developer to more 

efficiently obtain a complete loss of 

function of a targeted gene. We are also 

making available for public review 

scientific literature that we consulted 

prior to initiating the proposal. The 

literature supports exempting plants 

with these additional modifications. 

Under the first additional genetic 

modification proposed, plants would 

not be subject to the regulations when 

cellular repair of a targeted DNA break 

in the same location on two homologous 

chromosomes, in the absence of a repair 

template, results in homozygous or 

heterozygous biallelic mutations, each 

of which is a loss of function mutation. 

A double strand break followed by 

cellular repair often occurs in both 

paternal and maternal alleles (biallelic) 

during genome editing. As a range of 

DNA indels frequently occur after a 

double strand break, the mutation in the 

paternal allele often differs from the 

mutation in the maternal allele. Biallelic 

knockout mutations are easily obtained 

in conventional breeding through selffertilizing or backcrossing and selection. 

In this case, the biallelic mutation is 

usually homozygous. However, in cases 

where the deletions are not identical but 

both deletions lead to a loss of function 

of the allele, the phenotype will be the 

same as the homozygous biallelic 

mutation obtained through conventional 

breeding. If both alleles are modified by 

indels such that neither allele is 

functional, the size, position, and 

sequence of the indels within the gene 

need not be identical to qualify for the 

exemption. 

The second additional genetic 

modification proposed is a contiguous 

deletion of any size resulting from 

cellular repair of a targeted DNA break 

in the presence of an externally 

supplied repair template. The deletion 

can occur on one or two homologous 

chromosomes. This modification is 

similar to the one described in 

§ 340.1(b)(1), except that it allows an 

externally supplied repair template to 

be used. When genome editing is used 

to create a single DNA break, a range of 

indels result from the cellular repair 

mechanism. To limit the range of 

mutations recovered and, therefore, to 

more efficiently obtain a complete loss 

of function of the targeted gene(s), some 

developers also add a template to guide 

the repair process. To limit this 

proposed additional modification to 

what is achievable through conventional 

breeding, it would only apply to 

deletions created by the double strand 

break and externally supplied repair 

template. 

The third additional genetic 

modification proposed is for a change 

resulting from cellular repair of two 

targeted DNA breaks on a single 

chromosome or at the same location on 

two homologous chromosomes, when 

the repair results in a contiguous 

deletion of any size in the presence or 

absence of a repair template, or in a 

contiguous deletion of any size 

combined with an insertion of DNA in 

the absence of a repair template. The 

insertion cannot result from the 

insertion of exogenous construct DNA. 

The modifications on two homologous 

chromosomes can be heterozygous as 

long as each results in a loss of function 

of the targeted gene(s). To qualify for the 

exemption, the plant must have 

mutations that are restricted to a pair of 

homologous chromosomes in diploids 

and allopolyploids or any two 

homologous chromosomes in 

autopolyploids. Radiation mutagenesis, 

which is commonly used in 

conventional breeding, can create any 

size deletion. As mutations are typically 

detrimental to the organism, what is 

achievable in practice is limited by the 

viability and fertility of the organism. 

Large mutations can be maintained in a 

heterozygous state but do not tend to 

undergo homozygous inheritance 

(Naito, 2005).2 For example, in 

Arabidopsis, which has a genome size of 

135 Mb (Arabidopsis Genome Initiative, 

2000), a radiation-induced deletion of 

3.1 Mb was obtained that disrupted 852 

genes and was maintainable only as a 

heterozygote, presumably because genes 

essential for survival are present in the 

deleted region (Kazama, et al., 2017).3

Polyploid plants and those with large 

genomes are better able to accommodate 

even larger deletions (Men et al., 2002).4

For example, in hexaploid wheat, X-ray 

mutagenesis was used to create a 

mutant, ph1, widely used in breeding 

programs, that has a 70 Mb deletion 

(Sears, 1977).5 To put the size of this 

wheat deletion in perspective, it is 

larger than half of the entire genome of 

Arabidopsis. Based on the use of plants 

with large deletion mutations in 

conventional breeding programs, any 

size contiguous deletion created by two 

double strand breaks should be 

exempted because it falls well within 

what could be achieved through 

conventional breeding. 

After reviewing any comments we 

receive, we will announce our decision 

regarding the three new modifications 

that plants could contain and qualify for 

exemption in a subsequent notice. 

Authority: 7 U.S.C. 7701–7772 and 

7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 

2.80, and 371.3. 

Done in Washington, DC, this 14th day of 

July, 2021. 

Michael Watson, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2021–15236 Filed 7–16–21; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2021–0032] 

Notice of Request for Revision to and 

Extension of Approval of an 

Information Collection; National 

Poultry Improvement Plan 

AGENCY: Animal and Plant Health 

Inspection Service, Agriculture (USDA). 

ACTION: Revision to and extension of 

approval of an information collection; 

comment request. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995, this 

notice announces the Animal and Plant 

Health Inspection Service’s intention to 

request a revision to and extension of 

approval of an information collection 

associated with the National Poultry 

Improvement Plan. 

DATES: We will consider all comments 

that we receive on or before September 

17, 2021. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

www.regulations.gov. Enter APHIS– 

2021–0032 in the Search field. Select 

the Documents tab, then select the 

Comment button in the list of 

documents. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2021–0032, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. 


lotter on DSK11XQN23PROD with NOTICES1
37990 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

Supporting documents and any 

comments we receive on this docket 

may be viewed at www.regulations.gov 

or in our reading room, which is located 

in room 1620 of the USDA South 

Building, 14th Street and Independence 

Avenue SW, Washington, DC. Normal 

reading room hours are 8 a.m. to 4:30 

p.m., Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: For 

information on the National Poultry 

Improvement Plan, contact Dr. Elena 

Behnke, DVM, Senior Coordinator, 

National Poultry Improvement Plan, 

Veterinary Services, APHIS, 1506 

Klondike Road SW, Suite 101, Conyers, 

GA 30094; (770) 922–3496. For more 

detailed information on the information 

collection, contact Mr. Joseph Moxey, 

APHIS’ Paperwork Reduction Act 

Coordinator, at (301) 851–2483. 

SUPPLEMENTARY INFORMATION: 

Title: National Poultry Improvement 

Plan. 

OMB Control Number: 0579–0007. 

Type of Request: Revision to and 

extension of approval of an information 

collection. 

Abstract: Under the Animal Health 

Protection Act (7 U.S.C. 8301 et seq.), 

the Animal and Plant Health Inspection 

Service (APHIS) of the U.S. Department 

of Agriculture is authorized, among 

other things, to administer the National 

Poultry Improvement Plan (NPIP), the 

primary purpose of which is to protect 

the health of the U.S. poultry 

population. NPIP is a Federal-Stateindustry cooperative program for the 

improvement of poultry flocks and 

products through disease control 

techniques. Participation in all NPIP 

programs is voluntary, but flocks, 

hatcheries, and dealers of breeding 

poultry must first qualify as ‘‘U.S. 

Pullorum-Typhoid Clean’’ as a 

condition for participation in NPIP 

programs. The NPIP regulations are 

contained in 9 CFR part 56 and parts 

145 through 147. 

To administer the NPIP, APHIS 

requires a number of activities that 

include memoranda of understanding; 

flock selecting and testing reports and 

commercial waterfowl/game bird egg 

producing flock surveillance; reports of 

sales of hatching eggs, chicks and poults 

(including printing and mailing 

computerized printouts for small 

shipments); summaries of breeding 

flock, table-egg layer flock, meat-type 

chicken and turkey slaughter plant 

participation; reports of hatcheries, 

dealers, and independent flocks, tableegg producers, meat-type chicken and 

turkey slaughter plants participating in 

the NPIP; investigations of salmonella 

isolations in poultry; flock inspection 

and check testing reports; and hatchery 

inspection forms. Activities also include 

banding or marking of sentinel birds for 

identification prior to flock vaccination; 

requests for salmonella serotyping; 

applications for U.S. Avian influenza 

and Newcastle Clean Compartment and 

Clean Component Registrations and 

requests for removal; component audits; 

auditor applications for NPIP AI Clean 

Compartment Program; and compliance 

statements. Activities further include 

descriptions of animal identification 

and traceability processes; laboratory 

examination for Newcastle disease and 

reporting; diagnostic test evaluations; 

Newcastle disease biosecurity plans; 

indemnity compliance agreements; 

appraisal and indemnity claims for 

animals or materials destroyed; initial 

state response and containment plan; 

and recordkeeping. 

The information collection 

requirements listed above represent 

activities currently filed under Office of 

Management and Budget (OMB) control 

number 0579–0007, National Poultry 

Improvement Plan, and OMB control 

number 0579–0474, National Poultry 

Improvement Plan and Auxiliary 

Provisions. After OMB approves this 

combined information collection 

package (0579–0007), APHIS will retire 

OMB control number 0579–0474. 

We are asking OMB to approve our 

use of these information collection 

activities, as described, for an additional 

3 years. 

The purpose of this notice is to solicit 

comments from the public (as well as 

affected agencies) concerning our 

information collection. These comments 

will help us: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

Agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the collection 

of information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, through use, as 

appropriate, of automated, electronic, 

mechanical, and other collection 

technologies; e.g., permitting electronic 

submission of responses. 

Estimate of burden: The public 

burden for this collection of information 

is estimated to average 0.475 hours per 

response. 

Respondents: State agriculture 

officials; flock owners; breeders; 

hatchery operators; table-egg, meat-type 

chicken, and meat-type turkey 

producers; feedlot and slaughter plant 

personnel; approved laboratory 

personnel; prospective and certified 

auditors; visitors; and associated 

entities. 

Estimated annual number of 

respondents: 2,867. 

Estimated annual number of 

responses per respondent: 82. 

Estimated annual number of 

responses: 234,630. 

Estimated total annual burden on 

respondents: 111,339 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

also become a matter of public record. 

Done in Washington, DC, this 6th day of 

July 2021. 

Jack Shere, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2021–15185 Filed 7–16–21; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Farm Service Agency 

[Docket ID FSA–2021–0007] 

Notice of Funds Availability; Pandemic 

Livestock Indemnity Program (PLIP) 

AGENCY: Farm Service Agency, 

Agriculture (USDA). 

ACTION: Notification of funding 

availability. 

SUMMARY: The Farm Service Agency 

(FSA) is issuing this notice announcing 

the availability of funds for the 

Pandemic Livestock Indemnity Program 

(PLIP) to provide assistance to 

producers for losses of livestock and 

poultry depopulated from March 1, 

2020, through December 26, 2020, due 

to insufficient processing access as a 

result of the COVID–19 pandemic and 

for the cost of depopulation and 

disposal. FSA is implementing PLIP, as 

authorized by the Consolidated 

Appropriations Act, 2021 (CAA). 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Graham, Director; telephone: 

(202) 720–6825; email: 

Kimberly.Graham@usda.gov. Persons 

with disabilities who require alternative 

means for communication should 

contact the USDA Target Center at (202) 


lotter on DSK11XQN23PROD with NOTICES1