82 FR 13811 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 49 (March 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13811-13812 | |
| FR Document | 2017-05105 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13811-13812] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05105] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1427] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 14, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0466. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120 OMB Control Number 0910-0466--Extension FDA's regulations in part 120 (21 CFR part 120) mandate the application of HACCP procedures to the processing of fruit and vegetable juices. HACCP is a preventative system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA's statutory authority to regulate food safety under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a food is adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. The Agency also has authority under section 361 of the Public Health Service Act (42 U.S.C. 264) to issue and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from one State, territory, or possession to another, or from outside the United States into this country. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of that act. Under HACCP, processors of fruit and vegetable juices establish and follow a preplanned sequence of operations and observations (the HACCP plan) designed to avoid or eliminate one or more specific food hazards, and thereby ensure that their products are safe, wholesome, and not adulterated; in compliance with section 402 of the FD&C Act. Information development and recordkeeping are essential parts of any HACCP system. The information collection requirements are narrowly tailored to focus on the development of appropriate controls and document those aspects of processing that are critical to food safety. In the Federal Register of August 30, 2016 (81 FR 59636), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: [[Page 13812]] Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 120.6(c) and 120.12(a)(1) and (b)--Require 1,875 365 684,375 0.1 (6 minutes)........................ 68,438 written monitoring and correction records for Sanitation Standard Operating Procedures. 120.7, 120.10(a), and 120.12(a)(2), (b) and 2,300 1.1 2,530 20..................................... 50,600 (c)--Require written hazard analysis of food hazards. 120.8(a) and 20.12(a)(3), (b), and (c)--Require 1,560 1.1 1716 60..................................... 102,960 written HACCP plan. 120.8(b)(7) and 120.12(a)(4)(i) and (b)-- 1,450 14,600 21,170,000 0.01 (1 minute)........................ 211,700 Require a recordkeeping system that documents monitoring of the critical control points and other measurements as prescribed in the HACCP plan. 120.10(c) and 120.12(a)(4)(ii) and (b)--Require 1,840 12 22,080 0.1 (6 minutes)........................ 2,208 that all corrective actions taken in response to a deviation from a critical limit be documented. 120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) 1,840 52 95,680 0.1 (6 minutes)........................ 9,568 and (b)--Require records showing verification activities associated with the HACCP system. 120.11(b) and 120.12(a)(5) and (b)--Require 1,840 1 1,840 4...................................... 7,360 records showing validation activities associated with the HACCP system. 120.11(c) and 120.12(a)(5) and (b)--Require 1,840 1 1,840 4...................................... 7,360 documentation of revalidation of the hazard analysis upon any changes that might affect the original hazard analysis (applies when a firm does not have a HACCP plan because the original hazard analysis did not reveal hazards likely to occur). 120.14(a)(2), (c), and (d) and 120.12(b)-- 308 1 308 4...................................... 1,232 Require that juice importers have written procedures to ensure that the juice is processed in accordance with our regulations in part 120. -------------------------------------------------------------------------------------------------------- Total...................................... .............. .............. .............. ....................................... 461,426 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 1 provides our estimate of the total annual recordkeeping burden of our regulations in part 120. We base our estimate of the average burden per recordkeeping on our experience with the application of HACCP principles in food processing. We base our estimate of the number of recordkeepers on our estimate of the total number of juice manufacturing plants affected by the regulations (plants identified in our official establishment inventory plus very small apple juice and very small orange juice manufacturers). These estimates assume that every processor will prepare sanitary standard operating procedures and an HACCP plan and maintain the associated monitoring records, and that every importer will require product safety specifications. In fact, there are likely to be some small number of juice processors that, based upon their hazard analysis, determine that they are not required to have an HACCP plan under these regulations. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05105 Filed 3-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13811
of a possible total of 125 (for the total DEPARTMENT OF HEALTH AND Hazard Analysis and Critical Control
determinant score) a suitable choice for HUMAN SERVICES Point (HACCP) Procedures for the Safe
the data sufficiency threshold? Is the and Sanitary Processing and Importing
relative weight for each score Food and Drug Administration of Juice—21 CFR Part 120
appropriate? OMB Control Number 0910–0466—
7. How should NIOSH consider data [Docket No. FDA–2013–N–1427] Extension
collected on structural analogs or FDA’s regulations in part 120 (21 CFR
related chemicals in the banding Agency Information Collection
Activities; Submission for Office of part 120) mandate the application of
scheme? HACCP procedures to the processing of
Management and Budget Review;
8. Qualitative and quantitative Comment Request; Hazard Analysis fruit and vegetable juices. HACCP is a
technical criteria have been adopted for and Critical Control Point Procedures preventative system of hazard control
some endpoints. Is this approach for the Safe and Sanitary Processing designed to help ensure the safety of
adequately justified and suitably foods. The regulations were issued
and Importing of Juice
explained in the document? If not, how under FDA’s statutory authority to
should the explanations be refined? AGENCY: Food and Drug Administration, regulate food safety under section
HHS. 402(a)(4) of the Federal Food, Drug, and
9. If a chemical has two forms (vapor
Cosmetic Act (the FD&C Act) (21 U.S.C.
or particulate) in the workplace, we ACTION: Notice. 342(a)(4)). Under section 402(a)(4) of the
have recommended that the most FD&C Act, a food is adulterated if it is
protective OEB take precedence. Please SUMMARY: The Food and Drug prepared, packed, or held under
comment on the utility and adequacy of Administration (FDA) is announcing insanitary conditions whereby it may
that recommendation. that a proposed collection of have been contaminated with filth or
10. Acute toxicity information may be information has been submitted to the rendered injurious to health. The
presented in an array of different units. Office of Management and Budget Agency also has authority under section
We have attempted to address those (OMB) for review and clearance under 361 of the Public Health Service Act (42
possibilities in the banding criteria for the Paperwork Reduction Act of 1995. U.S.C. 264) to issue and enforce
the acute toxicity endpoint, especially regulations to prevent the introduction,
for inhalation exposures. Is this DATES: Fax written comments on the transmission, or spread of
information sufficiently clear? Are collection of information by April 14, communicable diseases from one State,
suitable rubrics for unit conversions 2017. territory, or possession to another, or
provided? from outside the United States into this
ADDRESSES: To ensure that comments on country. Under section 701(a) of the
11. Does this draft document the information collection are received, FD&C Act (21 U.S.C. 371(a)), FDA is
adequately describe the occupational OMB recommends that written authorized to issue regulations for the
exposure banding process in a way that comments be faxed to the Office of efficient enforcement of that act.
supports its use in assigning ranges of Information and Regulatory Affairs, Under HACCP, processors of fruit and
exposure concentrations to protect OMB, Attn: FDA Desk Officer, FAX: vegetable juices establish and follow a
worker health in the occupational 202–395–7285, or emailed to oira_ preplanned sequence of operations and
setting? submission@omb.eop.gov. All observations (the HACCP plan) designed
comments should be identified with the to avoid or eliminate one or more
Public Review
OMB control number 0910–0466. Also specific food hazards, and thereby
The external review of the draft include the FDA docket number found ensure that their products are safe,
document has been (1) developed in in brackets in the heading of this wholesome, and not adulterated; in
accordance with Office of Management document. compliance with section 402 of the
and Budget (OMB) guidelines, (2) is FD&C Act. Information development
FOR FURTHER INFORMATION CONTACT: FDA and recordkeeping are essential parts of
consistent with NIOSH peer review
PRA Staff, Office of Operations, Food any HACCP system. The information
practice, and (3) is meant to ensure that
and Drug Administration, Three White collection requirements are narrowly
credible and appropriate science is
Flint North, 10A63, 11601 Landsdown tailored to focus on the development of
reflected within the draft document.
St., North Bethesda, MD 20852, appropriate controls and document
Dated: March 10, 2017. PRAStaff@fda.hhs.gov. those aspects of processing that are
Frank Hearl, critical to food safety.
SUPPLEMENTARY INFORMATION: In
Chief of Staff, National Institute for In the Federal Register of August 30,
compliance with 44 U.S.C. 3507, FDA 2016 (81 FR 59636), FDA published a
Occupational Safety and Health, Centers for
has submitted the following proposed 60-day notice requesting public
Disease Control and Prevention.
collection of information to OMB for comment on the proposed collection of
[FR Doc. 2017–05115 Filed 3–14–17; 8:45 am]
review and clearance. information. No comments were
BILLING CODE 4163–19–P
received.
FDA estimates the burden of this
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
collection of information as follows:
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![13812 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
120.6(c) and 120.12(a)(1) and (b)—Require written monitoring and correc- 1,875 365 684,375 0.1 (6 minutes) ..... 68,438
tion records for Sanitation Standard Operating Procedures.
120.7, 120.10(a), and 120.12(a)(2), (b) and (c)—Require written hazard 2,300 1.1 2,530 20 ......................... 50,600
analysis of food hazards.
120.8(a) and 20.12(a)(3), (b), and (c)—Require written HACCP plan .......... 1,560 1.1 1716 60 ......................... 102,960
120.8(b)(7) and 120.12(a)(4)(i) and (b)—Require a recordkeeping system 1,450 14,600 21,170,000 0.01 (1 minute) ..... 211,700
that documents monitoring of the critical control points and other meas-
urements as prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii) and (b)—Require that all corrective actions 1,840 12 22,080 0.1 (6 minutes) ..... 2,208
taken in response to a deviation from a critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) and (b)—Require records 1,840 52 95,680 0.1 (6 minutes) ..... 9,568
showing verification activities associated with the HACCP system.
120.11(b) and 120.12(a)(5) and (b)—Require records showing validation 1,840 1 1,840 4 ........................... 7,360
activities associated with the HACCP system.
120.11(c) and 120.12(a)(5) and (b)—Require documentation of revalidation 1,840 1 1,840 4 ........................... 7,360
of the hazard analysis upon any changes that might affect the original
hazard analysis (applies when a firm does not have a HACCP plan be-
cause the original hazard analysis did not reveal hazards likely to occur).
120.14(a)(2), (c), and (d) and 120.12(b)—Require that juice importers have 308 1 308 4 ........................... 1,232
written procedures to ensure that the juice is processed in accordance
with our regulations in part 120.
Total ........................................................................................................ ........................ ........................ ........................ ............................... 461,426
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the DEPARTMENT OF HEALTH AND and Drug Administration, Three White
total annual recordkeeping burden of HUMAN SERVICES Flint North 10A–12M, 11601
our regulations in part 120. We base our Landsdown St., North Bethesda, MD
estimate of the average burden per Food and Drug Administration 20852, PRAStaff@fda.hhs.gov.
recordkeeping on our experience with [Docket No. FDA–2013–N–0796] SUPPLEMENTARY INFORMATION: In
the application of HACCP principles in compliance with 44 U.S.C. 3507, FDA
food processing. We base our estimate of Agency Information Collection has submitted the following proposed
the number of recordkeepers on our Activities; Submission for Office of collection of information to OMB for
estimate of the total number of juice Management and Budget Review; review and clearance.
manufacturing plants affected by the Comment Request; Testing
Communications on Medical Devices Testing Communications on Medical
regulations (plants identified in our Devices and Radiation-Emitting
official establishment inventory plus and Radiation-Emitting Products
Products—OMB Control Number 0910–
very small apple juice and very small AGENCY: Food and Drug Administration, 0678—Extension
orange juice manufacturers). These HHS. FDA is authorized by section
estimates assume that every processor ACTION: Notice. 1003(d)(2)(D) of the Federal Food, Drug,
will prepare sanitary standard operating and Cosmetic Act (21 U.S.C.
procedures and an HACCP plan and SUMMARY: The Food and Drug
Administration (FDA) is announcing 393(d)(2)(D)) to conduct educational
maintain the associated monitoring and public information programs
records, and that every importer will that a proposed collection of
information has been submitted to the relating to the safety of regulated
require product safety specifications. In medical devices and radiation-emitting
Office of Management and Budget
fact, there are likely to be some small (OMB) for review and clearance under products. FDA must conduct needed
number of juice processors that, based the Paperwork Reduction Act of 1995. research to ensure that such programs
upon their hazard analysis, determine have the highest likelihood of being
DATES: Fax written comments on the
that they are not required to have an collection of information by April 14, effective. Improving communications
HACCP plan under these regulations. 2017. about medical devices and radiation
Dated: March 9, 2017. emitting products will involve many
ADDRESSES: To ensure that comments on research methods, including individual
Leslie Kux, the information collection are received, in-depth interviews, mall-intercept
Associate Commissioner for Policy. OMB recommends that written interviews, focus groups, self-
[FR Doc. 2017–05105 Filed 3–14–17; 8:45 am] comments be faxed to the Office of administered surveys, gatekeeper
BILLING CODE 4164–01–P
Information and Regulatory Affairs, reviews, and omnibus telephone
OMB, Attn: FDA Desk Officer, FAX: surveys.
202–395–7285, or emailed to oira_
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
The information collected will serve
submission@omb.eop.gov. All three major purposes. First, as formative
comments should be identified with the research it will provide critical
OMB control number 0910–0678. Also knowledge needed about target
include the FDA docket number found audiences to develop messages and
in brackets in the heading of this campaigns about medical device and
document. radiation-emitting product use.
FOR FURTHER INFORMATION CONTACT: FDA Knowledge of consumer and health care
PRA Staff, Office of Operations, Food professional decision making processes
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Document Created: 2017-03-15 06:04:28
Document Modified: 2017-03-15 06:04:28
| 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 | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by April 14, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 13811 |
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