81 FR 88099 - Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 235 (December 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 235 (December 7, 2016)
| Page Range | 88099-88101 | |
| FR Document | 2016-29278 |
[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)] [Rules and Regulations] [Pages 88099-88101] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29278] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2011-N-0146] Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. [[Page 88100]] ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry and FDA staff entitled ``Third- Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA). The guidance is intended to describe the standards for accreditation of third-party certification bodies as required under the final rule entitled ``Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.'' In addition, this guidance discusses specific clauses of ISO/IEC 17021: 2015 and industry practice that are currently being used by third-party certification bodies and that FDA recommends accreditation bodies consider as a model when making accreditation decisions. DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-N-0146 for ``Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self- addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Charlotte A. Christin, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7526. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry and FDA staff entitled ``Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of July 24, 2015 (80 FR 44137), we made available a draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards'' and gave interested parties an opportunity to submit comments by October 7, 2015, for us to consider before beginning work on the final version of the guidance. Section 808 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 384d) was added by FSMA and directs FDA to establish a program for the recognition of accreditation bodies that accredit third-party certification bodies to conduct food safety audits and to issue food and/or facility certifications that FDA may use in certain circumstances to facilitate the entry of foods presented for import. [[Page 88101]] Section 808(b)(2) of the FD&C Act requires FDA to develop model accreditation standards that recognized accreditation bodies shall use to qualify third-party certification bodies for accreditation, and in so doing, to look to existing standards for certification bodies (as of the date of enactment of FSMA) to avoid unnecessary duplication of efforts and costs. This guidance constitutes the model accreditation standards referred to in section 808(b)(2) of the FD&C Act. The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by FSMA. FDA was guided in developing this guidance, in part, by the National Technology Transfer and Advancement Act of 1995, which directs Federal Agencies to use voluntary consensus standards in lieu of government-unique standards, except where inconsistent with law or otherwise impractical. In developing the guidance, FDA considered several voluntary consensus standards for their relevance to the qualifications of third- party certification bodies that would certify foreign food facilities and/or their foods for conformance with the requirements of the FD&C Act. FDA also sought to identify the standards most commonly used by stakeholders (e.g., other governments, public and private accreditation bodies, the food industry, and the international standards community) in qualifying third-party certification bodies for conducting food safety audits. As a result, FDA was guided in developing the model accreditation standards guidance document by International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) ISO/IEC 17021: Conformity Assessment--Requirements for bodies providing audit and certification management systems (2015) (ISO/IEC 17021:2015) and ISO/IEC 17065: Conformity Assessment--Requirements for bodies certifying products, processes and services (2012) (ISO/IEC 17065:2012). We received several comments on the draft guidance and have modified the final guidance where appropriate. We revised the guidance for clarity and conformance with the final rule. We also updated references to the ISO/IEC standards. The guidance announced in this notice finalizes the draft guidance dated July 2015. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collection of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information regarding ``Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications,'' have been approved under OMB control number 0910- 0750. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: December 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29278 Filed 12-6-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Rules and Regulations 88099
comments. We may change these special Novel or Unusual Design Features have been submitted in response to the
conditions based on the comments we The ERJ 190–300 will incorporate the prior opportunities for comment
receive. following novel or unusual design described above.
Background features: List of Subjects in 14 CFR Part 25
An automatic braking system with a
On September 13, 2013, Embraer S.A. pilot-selectable function that allows Aircraft, Aviation safety, Reporting
applied for an amendment to Type earlier braking at landing without pilot and recordkeeping requirements.
Certificate (TC) No. A57NM to include pedal input. When the autobrake system The authority citation for these
the new Model ERJ 190–300 series is armed before landing, it automatically special conditions is as follows:
airplanes. The ERJ 190–300, which is a commands a pre-defined braking action Authority: 49 U.S.C. 106(g), 40113, 44701,
derivative of the ERJ 190–100 STD after the main wheels touch down. This 44702, 44704.
currently approved under TC No. might cause a high nose gear sink rate,
A57NM, is a 97–114 passenger transport and potentially higher gear and airframe The Special Conditions
category airplane with two Pratt & loads than would occur with a Accordingly, pursuant to the
Whitney Model PW1900G engines, a traditional braking system. authority delegated to me by the
new wing design with a high aspect Administrator, the following special
Discussion
ratio and raked wingtip, digital fly-by- conditions are issued as part of the type
wire electronic flight control system, These special conditions define a certification basis for the Embraer S.A.
and an automatic braking system. landing pitchover condition that Model ERJ 190–300 series airplanes.
accounts for the effects of the automatic A landing pitchover condition must
Type Certification Basis braking system. The special conditions be addressed that takes into account the
Under the provisions of Title 14, Code define the airplane configuration, effect of the autobrake system. The
of Federal Regulations (14 CFR) 21.101, speeds, and other parameters necessary airplane is assumed to be at the design
Embraer S.A. must show that the ERJ to develop airframe and nose gear loads maximum landing weight, or at the
190–300 meets the applicable for this condition. The special maximum weight allowed with the
provisions of the regulations listed in conditions require that the airplane be autobrake system on. The airplane is
Type Certificate No. A57NM or the designed to support the resulting limit assumed to land in a tail-down attitude
applicable regulations in effect on the and ultimate loads as defined in and at the speeds defined in § 25.481.
date of application for the change, § 25.305. Following main gear contact, the
These special conditions contain the airplane is assumed to rotate about the
except for earlier amendments as agreed additional safety standards that the
upon by the FAA. Embraer S.A. must main gear wheels at the highest pitch
Administrator considers necessary to rate allowed by the autobrake system.
show that the ERJ 190–300 meets the establish a level of safety equivalent to
applicable provisions of 14 CFR part 25, This is considered a limit load
that established by the existing condition from which ultimate loads
as amended by Amendments 25–1 airworthiness standards.
through 25–137. must also be determined. Loads must be
Applicability determined for critical fuel and payload
If the Administrator finds that the
distributions and centers of gravity. The
applicable airworthiness regulations As discussed above, these special
effect of the autobrake system on fatigue
(i.e., 14 CFR part 25) do not contain conditions are applicable to the ERJ
loading spectra must also be
adequate or appropriate safety standards 190–300 series airplanes. Should
investigated. Nose gear loads, as well as
for the ERJ 190–300 because of a novel Embraer S.A. apply at a later date for a
airframe loads, must be determined. The
or unusual design feature, special change to the type certificate to include
airplane must meet § 25.305 for these
conditions are prescribed under the another model incorporating the same
loads.
provisions of § 21.16. novel or unusual design feature, these
Special conditions are initially special conditions would apply to that Issued in Renton, Washington, on
model as well. November 15, 2016.
applicable to the Model for which they
Paul Bernado,
are issued. Should the type certificate Conclusion
for that model be amended later to Acting Manager, Transport Airplane
This action affects only certain novel Directorate Aircraft Certification Service.
include any other model that
or unusual design features on one model [FR Doc. 2016–29358 Filed 12–6–16; 8:45 am]
incorporates the same novel or unusual
of airplanes. It is not a rule of general
design features, or should any other BILLING CODE 4910–13–P
applicability.
model already included on the same The substance of these special
type certificate be modified to conditions has been subjected to the
incorporate the same novel or unusual notice and comment period in several DEPARTMENT OF HEALTH AND
design feature, these special conditions prior instances and has been derived HUMAN SERVICES
would also apply to the other model without substantive change from those
under § 21.101. previously issued. It is unlikely that Food and Drug Administration
In addition to the applicable prior public comment would result in a
airworthiness regulations and special significant change from the substance 21 CFR Part 1
conditions, the ERJ 190–300 must contained herein. Therefore, because a
comply with the fuel vent and exhaust delay would affect the certification of [Docket No. FDA–2011–N–0146]
asabaliauskas on DSK3SPTVN1PROD with RULES
emission requirements of 14 CFR part the airplane, the FAA has determined
34 and the noise-certification Third-Party Certification Body
that prior public notice and comment
requirements of 14 CFR part 36. Accreditation for Food Safety Audits:
are unnecessary and impracticable, and
Model Accreditation Standards;
The FAA issues special conditions, as good cause exists for adopting these
Guidance for Industry and Food and
defined in 14 CFR 11.19, in accordance special conditions upon publication in
Drug Administration Staff; Availability
with § 11.38, and they become part of the Federal Register. The FAA is
the type certification basis under requesting comments to allow interested AGENCY: Food and Drug Administration,
§ 21.101. persons to submit views that may not HHS.
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![Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Rules and Regulations 88101
Section 808(b)(2) of the FD&C Act II. Paperwork Reduction Act of 1995 Legislation and Regulations, CA/VO/L/
requires FDA to develop model This guidance refers to previously R, 600 19th Street NW., SA–17, Room
accreditation standards that recognized approved collection of information 12–526B, Washington, DC 20522, 202–
accreditation bodies shall use to qualify found in FDA regulations. These 485–7641 or magadiapl@state.gov.
third-party certification bodies for collections of information are subject to SUPPLEMENTARY INFORMATION: Prior to
accreditation, and in so doing, to look review by the Office of Management and this amendment, an unmarried adult
to existing standards for certification Budget (OMB) under the Paperwork son or daughter who is not part of any
bodies (as of the date of enactment of Reduction Act of 1995 (44 U.S.C. 3501– other household and resides regularly in
FSMA) to avoid unnecessary 3520). The collections of information the household of the principal alien
duplication of efforts and costs. This regarding ‘‘Accreditation of Third Party must be classified in A or G visa
guidance constitutes the model Certification Bodies to Conduct Food classifications, even if otherwise eligible
accreditation standards referred to in Safety Audits and Issue Certifications,’’ for another nonimmigrant classification
section 808(b)(2) of the FD&C Act. The have been approved under OMB control and regardless of age or the intention of
guidance contains FDA number 0910–0750. the sending government or international
recommendations on third-party organization. Yet for purposes of
III. Electronic Access privileges and immunities, the
certification body qualifications for
accreditation to conduct food safety Persons with access to the Internet Department of State accepts only
audits and to issue food and/or facility may obtain the guidance at either http:// unmarried children under the age of 21,
certifications under an FDA program www.fda.gov/FoodGuidances or http:// or unmarried sons and daughters under
required by FSMA. www.regulations.gov. Use the FDA Web the age of 23 and in full-time attendance
site listed in the previous sentence to as students at post-secondary
FDA was guided in developing this
find the most current version of the educational institutions, as dependents.
guidance, in part, by the National
guidance. Similarly, under 8 CFR 214.2(a)(2) and
Technology Transfer and Advancement
Dated: December 1, 2016. (g)(2) for employment authorization
Act of 1995, which directs Federal purposes, Department of Homeland
Agencies to use voluntary consensus Leslie Kux,
Security (DHS) regulations generally
standards in lieu of government-unique Associate Commissioner for Policy.
only consider unmarried children under
standards, except where inconsistent [FR Doc. 2016–29278 Filed 12–6–16; 8:45 am]
the age of 21, or unmarried sons and
with law or otherwise impractical. BILLING CODE 4164–01–P daughters under the age of 23 and in
In developing the guidance, FDA full-time attendance as students at post-
considered several voluntary consensus secondary educational institutions, to be
standards for their relevance to the DEPARTMENT OF STATE dependents. (Under certain
qualifications of third-party certification circumstances, DHS, under its
bodies that would certify foreign food 22 CFR Part 41 regulations, may also recognize as
facilities and/or their foods for RIN 1400–AD96 dependents sons and daughters up to
conformance with the requirements of the age of 25 or of any age if physically
[Public Notice: 9638]
the FD&C Act. FDA also sought to or mentally challenged.) In practice,
identify the standards most commonly Visas: Classification of Immediate requiring A or G classification for sons
used by stakeholders (e.g., other Family Members as A, C–3, G, and and daughters above these age limits
governments, public and private NATO Nonimmigrants precludes them from obtaining a
accreditation bodies, the food industry, nonimmigrant classification that would
and the international standards AGENCY: State Department. enable them to accept employment in
community) in qualifying third-party ACTION: Final rule. the United States.
certification bodies for conducting food This rule narrows the definition of
SUMMARY: This rule amends the immediate family in the A, C–3 (aliens
safety audits. As a result, FDA was definition of immediate family for
guided in developing the model in transit under section 212(d)(8) of the
purposes of A, C–3, G, and NATO visa Immigration and Nationality Act, 8
accreditation standards guidance classifications in two ways: It revises
document by International Organization U.S.C. 1182(d)(8)), G, and relevant
the eligibility requirements for NATO nonimmigrant visa
for Standardization (ISO)/International unmarried adult sons and daughters age
Electrotechnical Commission (IEC) ISO/ classifications so that only unmarried
21 or older for these visa classifications, sons and daughters residing with the
IEC 17021: Conformity Assessment— and clarifies for purposes of G–4 visa
Requirements for bodies providing audit principal who are under the age of 21,
classification that the international or under the age of 23 and in full-time
and certification management systems organization employing the principal
(2015) (ISO/IEC 17021:2015) and ISO/ attendance as students at post-
alien must recognize an individual as secondary educational institutions, will
IEC 17065: Conformity Assessment— immediate family to be eligible for continue to be considered immediate
Requirements for bodies certifying derivative U.S. visa status. Furthermore, family. Any other unmarried son or
products, processes and services (2012) this rule permits qualified immediate daughter residing with the principal
(ISO/IEC 17065:2012). family members of A–1, A–2, G–1, G– will only qualify if he or she meets the
We received several comments on the 2, G–3, and G–4 nonimmigrants to be same criteria the rule imposes on other
asabaliauskas on DSK3SPTVN1PROD with RULES
draft guidance and have modified the independently classified as NATO–1, family members. In particular, he or she
final guidance where appropriate. We NATO–2, NATO–3, NATO–4, NATO–5, must be recognized as an ‘‘immediate
revised the guidance for clarity and and NATO–6. family member’’ by the sending
conformance with the final rule. We DATES: This final rule is effective on government or international
also updated references to the ISO/IEC December 7, 2016. organization for purposes of eligibility
standards. The guidance announced in FOR FURTHER INFORMATION CONTACT: for rights and benefits and also is
this notice finalizes the draft guidance Paul-Anthony L. Magadia, U.S. individually authorized by the
dated July 2015. Department of State, Office of Department. An adult son or daughter
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Document Created: 2016-12-07 05:31:36
Document Modified: 2016-12-07 05:31:36
| 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 | Notification of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Charlotte A. Christin, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7526. | |
| FR Citation | 81 FR 88099 |
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