83 FR 11136 - Honey Packers and Importers Research, Promotion, Consumer Education and Industry Information Order; Change in Producer Eligibility Requirements and Implementation of Charges for Past Due Assessments
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service Federal Register Volume 83, Issue 50 (March 14, 2018)
Agricultural Marketing Service
Federal Register Volume 83, Issue 50 (March 14, 2018)
| Page Range | 11136-11139 | |
| FR Document | 2018-05063 |
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)] [Rules and Regulations] [Pages 11136-11139] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05063] [[Page 11136]] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1212 [Document Number AMS-SC-16-0124] Honey Packers and Importers Research, Promotion, Consumer Education and Industry Information Order; Change in Producer Eligibility Requirements and Implementation of Charges for Past Due Assessments AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule revises the eligibility requirements for producer representatives on the Honey Packers and Importers Board (Board) and prescribes late payment and interest charges on past due assessments under the Agricultural Marketing Service's (AMS) regulation regarding a national research and promotion program for honey and honey products. This rule reduces the minimum production requirement for producers to serve on the Board and thereby allow more producers to be eligible to serve on the Board. This rule also prescribes late payment and interest charges on past due assessments to help facilitate program administration. DATES: Effective Date: April 13, 2018. FOR FURTHER INFORMATION CONTACT: Sue Coleman, Marketing Specialist, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-0244; telephone: (202)378-2569; facsimile: (202) 205-2800; or electronic mail: [email protected]. SUPPLEMENTARY INFORMATION: This rule affecting 7 CFR part 1212 is authorized under the Commodity Promotion, Research, and Information Act of 1996 (1996 Act) (7 U.S.C. 7411-7425). Executive Orders 12866, 13563, and 13771 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled ``Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' '' (February 2, 2017). Executive Order 13175 This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act (7 U.S.C. 7423) provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity. Under section 519 of the 1996 Act (7 U.S.C. 7418), a person subject to an order may file a written petition with USDA stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and request a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The 1996 Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of USDA's final ruling. Background This rule revises the eligibility requirements for producer representatives on the Board and prescribes late payment and interest charges on past due assessments under the Honey Packers and Importers Research, Promotion, Consumer Education and Industry Information Order. The part is administered by the Board with oversight by USDA. Under the part, assessments are collected from first handlers and importers and used for research and promotion projects designed to maintain and expand the market for honey and honey products in the United States and abroad. This rule reduces the minimum production requirement for producers to serve on the Board from 150,000 to 50,000 pounds annually and thereby allow more producers to be eligible to serve on the Board. This rule also prescribes late payment and interest charges on past due assessments to help facilitate program administration. Both of these actions were unanimously recommended by the Board. Producer Eligibility Requirements Section 1212.46 of the part provides authority for the Board to recommend amendments to the part. Section 1212.40 of the part provides that the Board have ten members--three first handlers, two importers, one importer-handler, three producers, and one marketing cooperative representative. Currently, eligible producers must produce a minimum of 150,000 pounds of honey in the United States annually based on the best three-year average of the most recent five calendar years. The Board has had difficulty over the past few years in identifying honey producers who meet the current eligibility requirement for production volume. U.S. honey production has decreased and fewer producers can meet the part's eligibility requirement. USDA's National Agricultural Statistics Service estimates U.S. honey production from producers with 5 or more colonies at 164 million pounds in 2008 \1\ and at 156 million pounds in 2015.\2\ The Board has been having difficulties identifying producer nominees who produce over the 150,000 pound threshold. --------------------------------------------------------------------------- \1\ USDA, National Agricultural Statistics Service, Honey Final Estimates 2008-2012, September 2014, p. 4; http://usda.mannlib.cornell.edu/usda/nass/SB1039/sb1039.pdf. \2\ USDA, National Agricultural Statistics Service, Honey, March 22, 2017, p. 2, http://usda.mannlib.cornell.edu/usda/current/Hone/Hone-03-22-2017.pdf. --------------------------------------------------------------------------- Thus, the Board formed a subcommittee in October 2015 to review this issue. Over the following six months, the Board conducted outreach with beekeeping associations to gather input about the need and the level to reduce the annual production volume requirement for producers to serve on the Board. The recommendation from [[Page 11137]] the associations to the subcommittee was that the minimum production requirement for producers be set at 50,000 pounds to increase the pool of eligible producers. The Board met in April 2016 and unanimously recommended that the part's minimum production requirement for producers be reduced from 150,000 to 50,000 pounds. This should allow more producers to be eligible to serve on the Board. Section 1212.40 of the part is revised accordingly. Charges on Past Due Assessments Section 1212.52 of the part specifies that the Board will cover its expenses by levying an assessment on first handlers and importers. First handlers must pay their assessments to the Board on a monthly basis no later than the fifteenth day of the month following the month in which the honey or honey products were marketed. Importers must pay assessments to the Board on honey and honey products imported into the United States through the U.S. Customs and Border Protection (Customs). If Customs does not collect an assessment from an importer, the importer must pay the assessment directly to the Board. The honey program also provides for two exemptions. Pursuant to Sec. 1212.53, first handlers and importers who handle or import less than 250,000 pounds of honey or honey products annually, and first handlers and importers of organic honey and honey products are exempt from the payment of assessments. Section 1212.52(g) of the part specifies that the Board shall impose a late payment charge on any first handler or importer who fails to pay their assessments to the Board on time. First handlers or importers subject to a late payment charge must also pay interest on the unpaid assessments for which they are liable. The late payment and interest charges must be prescribed in regulations issued by USDA. Assessment funds are used by the Board for activities designed to benefit all industry members. Thus, it is important that all assessed entities pay their assessments in a timely manner. Entities who fail to pay their assessments on time would be able to reap the benefits of Board programs at the expense of others. In addition, they would be able to utilize funds for their own use that should otherwise be paid to the Board to finance Board programs. Thus, the Board recommended that rates of late payment and interest charges for past due assessments be prescribed in the part's regulations. A late payment charge will be imposed upon first handlers and importers who fail to pay their assessments to the Board within 30 calendar days of the date when assessments are due. This one-time late payment charge will be 10 percent of the assessments due before interest charges have accrued. Additionally, interest at a rate of \2/3\ of 1 percent per month on the outstanding balance (which computes to an annual rate of 8 percent), including any late payment and accrued interest, will be added to any accounts for which payment has not been received within 30 calendar days of the date when assessments are due. Interest will continue to accrue monthly until the outstanding balance is paid to the Board. This action is expected to help facilitate program administration by providing an incentive for entities to remit their assessments in a timely manner, with the intent of creating a fair and equitable process among all assessed entities. Accordingly, a new subpart C is added to the part's regulations regarding past due assessments, and a new Sec. 1212.520 is added to subpart C. Final Regulatory Flexibility Act Analysis In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of this rule on small entities. Accordingly, AMS has considered the economic impact of this action on such entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000, and small agricultural service firms (first handlers and importers) as those having annual receipts of no more than $7.5 million. The Board reported that there are about 752 importers and 41 first handlers of honey and honey products covered under the program during the 2016 fiscal period. Seventeen out of the 41 first handlers (41 percent) and 25 out of the 752 importers (3 percent) accounted for 90 percent of the assessments in their respective categories. Total assessments for 2016 were $6.74 million, of which $1.75 million (26 percent) came from first handlers and $4.99 million (74 percent) was paid by importers. This data can be used to compute an estimate of average annual revenue from honey sales from each of these categories, which in turn helps to estimate the number of large and small first handlers and importers. As mentioned above, 17 first handlers account for 90 percent of the domestic assessments. Multiplying first handler assessments in 2016 of $1,750,155 by 0.9 and then dividing by 17 yields an average annual assessment of $92,655 for the first handlers in this category. Dividing this figure ($92,655) by the assessment rate of 1.5 cents per pound ($0.015) yields an average quantity per first handler of 6.177 million pounds. Multiplying 6.177 million pounds by the average 2016 U.S. domestic price of $2.08 per pound \3\ yields an average, annual honey revenue per handler of $12.85 million, which is well above the SBA threshold of $7.5 million. It should be noted that this revenue estimate is based on the average price at the producer level, and the $12.85 million is an estimate of the total value at which the average size handler acquired the honey from producers. Therefore, most of the 17 first handlers that pay 90 percent of the domestic assessments are likely to be large firms according to the SBA definition. --------------------------------------------------------------------------- \3\ USDA, NASS, Honey, March 22, 2017, p. 3, http://usda.mannlib.cornell.edu/usda/current/Hone/Hone-03-22-2017.pdf. --------------------------------------------------------------------------- An equivalent computation can be made for the 25 importers who paid 90 percent of the $4,991,926 in assessments in 2016. Of the 25 importers, the average assessment per importer was $179,709. Dividing the average assessment per importer by the assessment rate of $0.015 per pound yields an average quantity per importer estimate of 11.981 million pounds. For honey imports, the equivalent of the season average price for domestic honey is referred to as a ``unit value.'' The unit value of $1.24 per pound is computed by dividing annual imported honey value of $417.31 million by average quantity of 335.69 million pounds (import data from the Foreign Agricultural Service). Multiplying the $1.24 unit value by the average quantity of 11.981 million pounds yields average annual honey revenue per importer figure of $14.856 million, almost two times the SBA threshold figure of $7.5 million for a large firm. Therefore, the majority of the 25 importers that pay 90 percent of the assessments are large firms, according to the SBA definition. Comparable computations can be made to determine the average 2016 honey revenue for the 24 first handlers and 727 importers that paid 10 percent of the assessments in the first handler and importer categories. The first handler and importer average annual honey revenue figures are approximately $1,011,000 and $57,000, [[Page 11138]] respectively, indicating that the vast majority are small businesses (in terms of honey sales), under the SBA large business threshold of $7.5 million in annual sales. Based on the foregoing, the majority of first handlers and importers may be classified as small entities. This rule relaxes the part's eligibility requirements for producer representatives on the Board as specified in section 1212.40 of the part. The program currently requires that producer representatives produce a minimum of 150,000 pounds of honey (based on the best three year average of the most recent five calendar years) in the United States annually. U.S. honey production has been decreasing and fewer producers can meet this eligibility requirement. Thus, the Board unanimously recommended reducing the minimum production requirement from 150,000 to 50,000 pounds annually. This will allow for a greater pool of producer nominees to be eligible to serve on the Board. Authority for this action is provided in Sec. 1212.46(d) of the part. This rule also prescribes charges for past due assessments under the part. A new Sec. 1212.520 is added to the part specifying a one- time late payment charge of 10 percent of the assessments due and interest at a rate of \2/3\ of 1 percent per month (or 8 percent on an annual basis) on the outstanding balance, including any late payment and accrued interest. This section is included in a new subpart C--Past Due Assessments. Authority for this action is provided in Sec. 1212.52(g) of the part and section 517(e) of the 1996 Act. Regarding the economic impact of this rule on affected entities, relaxing the eligibility requirements for producer representatives on the Board is administrative in nature and will have no economic impact on entities covered under the program. This change will help increase the number of producers who will be eligible to serve on the Board. Eligible producers, first handlers and importers interested in serving on the Board will have to complete a background questionnaire. Those requirements are addressed later in this rule in the section titled Reporting and Recordkeeping Requirements. Prescribing charges for past due assessments will impose no additional costs on first handlers and importers who pay their assessments on time. It merely provides an incentive for entities to remit their assessments in a timely manner. For all entities who are delinquent in paying assessments, both large and small, the charges will be applied uniformly. As for the impact on the industry as a whole, this action will help facilitate program administration by providing an incentive for entities to remit their assessments in a timely manner, with the intent of creating a fair and equitable process for all assessed entities. Additionally, as previously mentioned, the part also provides for two exemptions. First handlers and importers who handle or import less than 250,000 pounds of honey or honey products annually, and first handlers and importers of organic honey and honey products are exempt from the payment of assessments. Regarding alternatives, one option to the action regarding producer eligibility would be to maintain the status quo and not reduce the production threshold for producers to be eligible to serve on the Board. However, the Board has been having difficulty identifying producer nominees who produce over 150,000 pounds of honey annually. After outreach to beekeeping associations, the Board concluded that reducing the minimum production requirement for producers from 150,000 to 50,000 pounds annually is appropriate to increase the pool of eligible producers. Likewise, an alternative to the action to prescribe late payment and interest charges for past due assessments would be to maintain the status quo and not prescribe these charges. However, the Board determined that implementing such charges will help facilitate program administration by encouraging entities to pay their assessments in a timely manner. The Board reviewed rates of late payment and interest charges prescribed in other research and promotion programs and concluded that the late payment charge and the interest charge contained in this rule is appropriate. Reporting and Recordkeeping Requirements In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection requirements that are imposed by the part have been previously approved by OMB under OMB control number 0581-0093. Additionally, Board nominees (including producers) must submit a Background Information form (AD-755) to ensure they are qualified to serve on the Board. The time to complete that form is estimated at 30 minutes per response. The background form is approved under OMB control no. 0505-0001. This rule will not result in a change to the information collection and recordkeeping requirements previously approved and will impose no additional reporting requirements and recordkeeping burden on honey producers, first handlers or importers. As with all Federal promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. Regarding outreach efforts, as previously mentioned, this action was discussed at a subcommittee in October 2015. The Board conducted outreach over the following six months to beekeeping associations to gather input about the need to reduce the annual production volume requirement for eligible producers on the Board. The Board met in April 2016 and unanimously recommended reducing the production volume requirement from 150,000 to 50,000 pounds annually. The Board also recommended prescribing late payment charges and interest on past due assessments in the part's regulations. All of the Board's meetings are open to the public and interested persons are invited to participate and express their views. A proposed rule concerning this action was published in the Federal Register on December 22, 2017 (82 FR 60687). The Board sent the proposed rule directly to beekeeping associations, the Board, and assessment payers. Additionally, the Board included notification about the proposal and internet links in its industry newsletter. Finally, the proposal was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending January 22, 2018, was provided to allow interested persons to submit comments. Analysis of Comment One comment was received in response to the proposed rule. The comment requested two public seats on the Board because of taxpayer dollars and environmental concerns. Currently, the plan does not authorize a Board public member. The national research and promotion program for honey and honey products is funded through assessments paid by honey first handlers and importers. This comment is considered outside the scope. These types of concerns can be presented to the Board for their consideration. In addition, all Board meetings are open to the public to attend. No changes have been made to the rule based on this comment. After consideration of all relevant matters presented, including the information and recommendation [[Page 11139]] submitted by the Board and other available information, it is hereby found that this rule, as hereinafter set forth, is consistent with and will effectuate the purposes of the 1996 Act. List of Subjects in 7 CFR Part 1212 Administrative practice and procedure, Advertising, Consumer information, Honey Packer and Importer promotion, Marketing agreements, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, 7 CFR part 1212 is amended as follows: PART 1212--HONEY PACKERS AND IMPORTERS RESEARCH, PROMOTION, CONSUMER EDUCATION AND INDUSTRY INFORMATION ORDER 0 1. The authority citation for 7 CFR part 1212 continues to read as follows: Authority: 7 U.S.C. 7411-7425; 7 U.S.C. 7401. 0 2. Section 1212.40 is revised to read as follows: Sec. 1212.40 Establishment and membership. The Honey Packers and Importers Board is established to administer the terms and provisions of this part. The Board shall have ten members, composed of three first handler representatives, two importer representatives, one importer-handler representative, three producer representatives, and one marketing cooperative representative. The importer-handler representative must import at least 75 percent of the honey or honey products they market in the United States and handle at least 250,000 pounds annually. In addition, the producer representatives must produce a minimum of 50,000 pounds of honey in the United States annually based on the best three-year average of the most recent five calendar years, as certified by producers. The Secretary will appoint members to the Board from nominees submitted in accordance with Sec. 1212.42. The Secretary shall also appoint an alternate for each member. 0 3. Subpart C is added to read as follows: Subpart C--Past Due Assessments Sec. 1212.520 Late payment and interest charges for past due assessments. (a) A late payment charge will be imposed on any first handler or importer who fails to make timely remittance to the Board of the total assessments for which they are liable. The late payment will be imposed on any assessments not received within 30 calendar days of the date when assessments are due. This one-time late payment charge will be 10 percent of the assessments due before interest charges have accrued. (b) In addition to the late payment charge, \2/3\ of 1 percent per month (or an annual rate of 8 percent) interest on the outstanding balance, including any late payment and accrued interest, will be added to any accounts for which payment has not been received within 30 calendar days of the date when assessments are due. Interest will continue to accrue monthly until the outstanding balance is paid to the Board. Dated: March 8, 2018. Bruce Summers, Acting Administrator. [FR Doc. 2018-05063 Filed 3-13-18; 8:45 am] BILLING CODE 3410-02-P
![11136 Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Rules and Regulations
DEPARTMENT OF AGRICULTURE category of regulatory actions that the the Honey Packers and Importers
Office of Management and Budget Research, Promotion, Consumer
Agricultural Marketing Service (OMB) exempted from Executive Order Education and Industry Information
12866 review. Additionally, because Order. The part is administered by the
7 CFR Part 1212 this rule does not meet the definition of Board with oversight by USDA. Under
[Document Number AMS–SC–16–0124]
a significant regulatory action it does the part, assessments are collected from
not trigger the requirements contained first handlers and importers and used
Honey Packers and Importers in Executive Order 13771. See OMB’s for research and promotion projects
Research, Promotion, Consumer Memorandum titled ‘‘Interim Guidance designed to maintain and expand the
Education and Industry Information Implementing Section 2 of the Executive market for honey and honey products in
Order; Change in Producer Eligibility Order of January 30, 2017 titled the United States and abroad. This rule
Requirements and Implementation of ‘Reducing Regulation and Controlling reduces the minimum production
Charges for Past Due Assessments Regulatory Costs’ ’’ (February 2, 2017). requirement for producers to serve on
the Board from 150,000 to 50,000
AGENCY: Agricultural Marketing Service, Executive Order 13175
pounds annually and thereby allow
USDA. This action has been reviewed in more producers to be eligible to serve on
ACTION: Final rule. accordance with the requirements of the Board. This rule also prescribes late
Executive Order 13175, Consultation payment and interest charges on past
SUMMARY: This rule revises the and Coordination with Indian Tribal due assessments to help facilitate
eligibility requirements for producer Governments. The review reveals that program administration. Both of these
representatives on the Honey Packers this regulation would not have actions were unanimously
and Importers Board (Board) and substantial and direct effects on Tribal recommended by the Board.
prescribes late payment and interest governments and would not have
charges on past due assessments under significant Tribal implications. Producer Eligibility Requirements
the Agricultural Marketing Service’s Section 1212.46 of the part provides
Executive Order 12988
(AMS) regulation regarding a national authority for the Board to recommend
research and promotion program for This rule has been reviewed under amendments to the part. Section
honey and honey products. This rule Executive Order 12988, Civil Justice 1212.40 of the part provides that the
reduces the minimum production Reform. It is not intended to have Board have ten members—three first
requirement for producers to serve on retroactive effect. Section 524 of the handlers, two importers, one importer-
the Board and thereby allow more 1996 Act (7 U.S.C. 7423) provides that handler, three producers, and one
producers to be eligible to serve on the it shall not affect or preempt any other marketing cooperative representative.
Board. This rule also prescribes late Federal or State law authorizing Currently, eligible producers must
payment and interest charges on past promotion or research relating to an produce a minimum of 150,000 pounds
due assessments to help facilitate agricultural commodity. of honey in the United States annually
program administration. Under section 519 of the 1996 Act (7 based on the best three-year average of
U.S.C. 7418), a person subject to an the most recent five calendar years.
DATES: Effective Date: April 13, 2018.
order may file a written petition with The Board has had difficulty over the
FOR FURTHER INFORMATION CONTACT: Sue USDA stating that an order, any past few years in identifying honey
Coleman, Marketing Specialist, provision of an order, or any obligation producers who meet the current
Promotion and Economics Division, imposed in connection with an order, is eligibility requirement for production
Specialty Crops Program, AMS, USDA, not established in accordance with the volume. U.S. honey production has
1400 Independence Avenue SW, Room law, and request a modification of an decreased and fewer producers can meet
1406–S, Stop 0244, Washington, DC order or an exemption from an order. the part’s eligibility requirement.
20250–0244; telephone: (202)378–2569; Any petition filed challenging an order, USDA’s National Agricultural Statistics
facsimile: (202) 205–2800; or electronic any provision of an order, or any Service estimates U.S. honey production
mail: Sue.Coleman@ams.usda.gov. obligation imposed in connection with from producers with 5 or more colonies
SUPPLEMENTARY INFORMATION: This rule an order, shall be filed within two years at 164 million pounds in 2008 1 and at
affecting 7 CFR part 1212 is authorized after the effective date of an order, 156 million pounds in 2015.2 The Board
under the Commodity Promotion, provision, or obligation subject to has been having difficulties identifying
Research, and Information Act of 1996 challenge in the petition. The petitioner producer nominees who produce over
(1996 Act) (7 U.S.C. 7411–7425). will have the opportunity for a hearing the 150,000 pound threshold.
Executive Orders 12866, 13563, and on the petition. Thereafter, USDA will Thus, the Board formed a
13771 issue a ruling on the petition. The 1996 subcommittee in October 2015 to review
Act provides that the district court of this issue. Over the following six
Executive Orders 12866 and 13563 the United States for any district in months, the Board conducted outreach
direct agencies to assess all costs and which the petitioner resides or conducts with beekeeping associations to gather
benefits of available regulatory business shall have the jurisdiction to input about the need and the level to
alternatives and, if regulation is review a final ruling on the petition, if reduce the annual production volume
necessary, to select regulatory the petitioner files a complaint for that requirement for producers to serve on
approaches that maximize net benefits purpose not later than 20 days after the the Board. The recommendation from
(including potential economic, date of the entry of USDA’s final ruling.
environmental, public health and safety
daltland on DSKBBV9HB2PROD with RULES
1 USDA, National Agricultural Statistics Service,
effects, distributive impacts and equity). Background Honey Final Estimates 2008–2012, September 2014,
Executive Order 13563 emphasizes the This rule revises the eligibility p. 4; http://usda.mannlib.cornell.edu/usda/nass/
importance of quantifying both costs requirements for producer SB1039/sb1039.pdf.
2 USDA, National Agricultural Statistics Service,
and benefits, reducing costs, representatives on the Board and Honey, March 22, 2017, p. 2, http://usda.mannlib.
harmonizing rules and promoting prescribes late payment and interest cornell.edu/usda/current/Hone/Hone-03-22-
flexibility. This action falls within a charges on past due assessments under 2017.pdf.
VerDate Sep<11>2014 16:14 Mar 13, 2018 Jkt 244001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1](https://thefederalregister.org/doc/83_FR_11186/page/1.svg)
![Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Rules and Regulations 11139
submitted by the Board and other any assessments not received within 30 Background
available information, it is hereby found calendar days of the date when The Virus-Serum-Toxin Act
that this rule, as hereinafter set forth, is assessments are due. This one-time late regulations in 9 CFR part 114 (referred
consistent with and will effectuate the payment charge will be 10 percent of to below as the regulations), contain
purposes of the 1996 Act. the assessments due before interest requirements for computing expiration
charges have accrued. dates and determining expiration dating
List of Subjects in 7 CFR Part 1212
(b) In addition to the late payment periods (stability) for veterinary
Administrative practice and charge, 2⁄3 of 1 percent per month (or an biologics. Currently, § 114.12 of the
procedure, Advertising, Consumer annual rate of 8 percent) interest on the regulations requires each serial or
information, Honey Packer and Importer outstanding balance, including any late subserial of veterinary biological
promotion, Marketing agreements, payment and accrued interest, will be products prepared in a licensed
Reporting and recordkeeping added to any accounts for which establishment to be given an expiration
requirements. payment has not been received within date, and § 114.13 provides that the
For the reasons set forth in the 30 calendar days of the date when expiration date for each product shall be
preamble, 7 CFR part 1212 is amended assessments are due. Interest will computed from the date of the initiation
as follows: continue to accrue monthly until the of the potency test.
outstanding balance is paid to the Prior to licensure, licensees and
PART 1212—HONEY PACKERS AND Board. permittees must submit preliminary
IMPORTERS RESEARCH, information to support the dating period
Dated: March 8, 2018.
PROMOTION, CONSUMER shown on its labeling. Products are
EDUCATION AND INDUSTRY Bruce Summers,
Acting Administrator. licensed with the provision that the
INFORMATION ORDER dating period must be confirmed by
[FR Doc. 2018–05063 Filed 3–13–18; 8:45 am]
■ 1. The authority citation for 7 CFR real-time stability testing at the end of
BILLING CODE 3410–02–P
part 1212 continues to read as follows: the predicted shelf life. Currently, the
requirement in § 114.13 of the
Authority: 7 U.S.C. 7411–7425; 7 U.S.C.
DEPARTMENT OF AGRICULTURE regulations for confirming stability is
7401.
contingent upon whether a product
■ 2. Section 1212.40 is revised to read consists of viable or non-viable
Animal and Plant Health Inspection
as follows: organisms. For products consisting of
Service
§ 1212.40 Establishment and membership. viable organisms, each serial must be
The Honey Packers and Importers 9 CFR Parts 101 and 114 tested for potency at release and at the
Board is established to administer the approximate expiration date until a
[Docket No. APHIS–2009–0028]
terms and provisions of this part. The statistically valid stability record has
Board shall have ten members, RIN 0579–AD06 been established. For products
composed of three first handler consisting of non-viable organisms, each
Viruses, Serums, Toxins, and serial presented in support of licensure
representatives, two importer
Analogous Products; Expiration Date (prelicensing serials) must be tested for
representatives, one importer-handler
Required for Serial and Subserials and potency at release and at or after the
representative, three producer
Determination of Expiration Date of dating requested. Products with
representatives, and one marketing
Product satisfactory potency tests at the
cooperative representative. The
importer-handler representative must AGENCY: Animal and Plant Health beginning and end of dating are
import at least 75 percent of the honey Inspection Service, USDA. considered to be efficacious throughout
or honey products they market in the the requested dating period. Current
ACTION: Final rule. science, however, considers stability
United States and handle at least
250,000 pounds annually. In addition, SUMMARY: We are amending the estimates based on potency tests
the producer representatives must regulations to clarify that the expiration conducted at the beginning and end of
produce a minimum of 50,000 pounds date of a serial or subserial of a the dating (a two-point profile) to be
of honey in the United States annually veterinary biologic should be computed inaccurate and imprecise.1
based on the best three-year average of from the date of the initiation of the first To address this situation, on
the most recent five calendar years, as potency test. We are also requiring the September 17, 2010, we published in
certified by producers. The Secretary expiration dating period (stability) of a the Federal Register (75 FR 56916–
will appoint members to the Board from product to be confirmed by conducting 56919, Docket No. APHIS–2009–0028) a
nominees submitted in accordance with a real-time stability study with a proposal 2 to amend the regulations by
§ 1212.42. The Secretary shall also stability-indicating assay, stability clarifying that the expiration date of a
appoint an alternate for each member. monitoring of products after licensing, serial or subserial of a veterinary
and specifying a single standard for biologic should be computed from the
■ 3. Subpart C is added to read as
determining the expiration date for date of the initiation of the first potency
follows: test. We also proposed to require the
veterinary biologics
Subpart C—Past Due Assessments expiration dating period (stability) of a
DATES: Effective April 13, 2018. product to be confirmed by a real-time
§ 1212.520 Late payment and interest FOR FURTHER INFORMATION CONTACT: Dr. stability study with a stability-
charges for past due assessments. Donna L. Malloy, Section Leader, indicating assay; require stability
daltland on DSKBBV9HB2PROD with RULES
(a) A late payment charge will be Operational Support, Center for
imposed on any first handler or Veterinary Biologics Policy, Evaluation, 1 Capen, R., et al. (2012). On the shelf life of
importer who fails to make timely and Licensing, VS, APHIS, 4700 River pharmaceutical products. AAPS PharmSciTech.
Road, Unit 148, Riverdale, MD 20737– DOI: 10.1208/s12249–012–9815–2.
remittance to the Board of the total 2 To view the proposed rule and the comments
assessments for which they are liable. 1231; (301) 851–3426. we received, go to http://www.regulations.gov/
The late payment will be imposed on SUPPLEMENTARY INFORMATION: #!docketDetail;D=APHIS-2009-0028.
VerDate Sep<11>2014 18:20 Mar 13, 2018 Jkt 244001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1](https://thefederalregister.org/doc/83_FR_11186/page/4.svg)
Document Created: 2018-03-14 01:06:40
Document Modified: 2018-03-14 01:06:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | Effective Date: April 13, 2018. | |
| Contact | Sue Coleman, Marketing Specialist, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-0244; telephone: (202)378-2569; facsimile: (202) 205-2800; or electronic mail: [email protected] | |
| FR Citation | 83 FR 11136 | |
| CFR Associated | Administrative Practice and Procedure; Advertising; Consumer Information; Honey Packer and Importer Promotion; Marketing Agreements and Reporting and Recordkeeping Requirements |
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