Submitted via: sp2000-02@nist.gov 6718 Kenwood Forest Lane

February 26, 2018 Bethesda, MD 20815 USA

Ms. Lisa Carnahan Tel : +1 240 507 3392

Standards Coordination Office

National Institute of Standards and Technology

100 Bureau Drive

Gaithersburg, MD 20899

Ref: IFIA comments on the “Draft Conformity Assessment Considerations for Federal Agencies”

Dear Ms. Carnahan,

The International Federation of Inspection Agencies (“IFIA”) is pleased to provide comments on the “Draft

Conformity Assessment Considerations for Federal Agencies”.

IFIA is a trade federation that represents over 60 of the world’s leading independent third-party testing,

inspection and certification (TIC) companies. IFIA members offer conformity assessment services, including

testing, inspection, certification, systems audits, advisory and training, technical and documentary support.

These services help manufacturers gain global market access and help ensure that not only regulatory

requirements are fulfilled, but also that reliability, economic value, environmental impact and sustainability

are enhanced.

We appreciate the opportunity to offer the following comments and look forward to continuing the discussion

and supporting NIST’s efforts.

Sincerely,

Roberta Telles Hanane Taidi

IFIA IFIA

Executive Director Americas Director General

rtelles@ifia-federation.org htaidi@ifia-federation.org

M: +1.240.507.3392 M: +32473629947

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General comments:

IFIA applauds NIST’s extensive efforts to consult stakeholders throughout the process of developing the

“Draft Conformity Assessment Considerations for Federal Agencies”. IFIA welcomes language in the

Considerations document that stresses the importance of transparency and stakeholder engagement

by federal agencies as they are designing conformity assessment programs. Transparency and

engagement at the earliest stage is key for the success of a program. However, IFIA has some concerns

with the current proposed document:

 lack of neutrality of methods of conformity and promotion of one method of conformity assessment

over others;

 lack of language reinforcing OMB A-119 policy that agencies should, whenever possible, leverage

private sector conformity assessment in lieu of public-sector conformity assessment;

 failure to encourage agencies to use terms/definitions consistent with ISO/IEC 17000 standards;

 unnecessary emphasis regarding government-run laboratories;

 lack of language regarding reciprocity in the acceptance of conformity assessment results; and

 duplication of concepts with the companion ABCs document.

IFIA recommends that NIST considers removing any overlap of content between the Considerations and

the ABCs documents, since the ABCs is an accompanying document to the Considerations. The ABCs

should provide a user-friendly overview of key conformity assessment concepts. The Considerations

document should not repeat those concepts but focus instead on identifying the types of questions/criteria

agencies should consider when selecting methods of conformity. Please see Annex 1 with full set of

suggested questions and the answers depending on the method of conformity (first or third-party) for NIST’s

consideration.

IFIA recommends that both the ABCs and the Considerations documents clearly convey that there are

different avenues for demonstrating compliance, and each of these avenues deliver different levels

of assurance which are applied based on what is needed to manage risks and have the level of confidence

needed for the specific situation.

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IFIA recommends that the documents be rewritten to remove any language that portrays one method as

preferential or more “trade-friendly” than another. As a non-regulatory agency, NIST should strive to be

“method-neutral” in its approach to coordinating conformity assessment in the United States.

Also, the language in the documents seem to conflate methods of conformity with conformity assessment

activities and some of the descriptions are not based on the ISO/IEC standards that apply to conformity

assessment. IFIA recommends aligning the document with the vocabulary and definitions in the ISO/IEC

17000 series.1

Specific comments:

Lines 146-148 is an excerpt from OMB A-119, pg. 30; however, the language is out of context since NIST

did not include the entire paragraph from A-119, which describe the possible contributions of private sector

conformity assessment. IFIA recommends that NIST takes the opportunity throughout the document to

reinforce that agencies should follow OMB policy and leverage private sector conformity assessment

activities whenever possible. IFIA recommends that NIST include the entire paragraph from OMB A-119 to

read as follow:

“Agencies should also design conformity assessment programs with the objectives of furthering

outcomes that are closely aligned with market dynamics and otherwise maximize net benefits to

society. In this context, agencies should recognize the possible contribution of private sector

conformity assessment activities. When properly conducted, conformity assessments

conducted by private sector conformity assessment bodies can increase productivity and

efficiency in government and industry, expand opportunities for international trade, conserve

resources, improve health and safety, and protect the environment.”2

Lines 230-231: Replace “their stakeholders” with “ISO/IEC standards”:

“Each agency should consider using terms that are consistent with ISO/IEC standards”.

IFIA recommends that NIST encourages agencies to consider using terms and definitions consistent with

ISO/IEC definitions. There is no benefit to anyone - and it could become quite confusing and unproductive

for stakeholders (and for interagency coordination) - if agencies are encouraged to use their own conformity

assessment terms and definitions.

1 https://www.iso.org/obp/ui/#iso:std:iso-iec:17000:ed-1:v1:en:sec:3.1

2 https://www.nist.gov/sites/default/files/revised_circular_a-119_as_of_01-22-2016.pdf

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Lines 321-324 states the following:

“Understand the perspective with respect to their views on: the potential impact (positive and

negative) conformity assessment activities may have on the market’s ability to produce/deliver

product to meet demand; the potential impact on demand (increase or decrease); and the potential

impact on the use of the product/service.”

It is not clear how does the method for demonstrating compliance impact the market’s ability to meet

demand for the product? Agencies should understand the markets that might be impacted by the

regulations. Once the agency determines that there is a need to regulate, industry has to demonstrate

compliance, and the agency has to determine how this demonstration will take place. The determination

of the method should be based on the objectives and confidence needs of the regulator to fulfill its mission.

This will depend on various factors, such as the risks associated with the object of compliance, how likely

non-compliance is, what the industry’s track record is, how much trust there is in the supply chain, the

societal costs of non-compliance, the agency’s resources and capabilities, among others.

Lines 337-338:

“Understand the capacity needs and requirements for conformity assessment programs. Federal

conformity assessment programs should not be a bottleneck in the private sector meeting demand.”

and line 867:

“(...) understanding capacity needs so that the model does not create built in bottle-necks.”

It is not clear what NIST means when it states that agencies need to “understand capacity needs” and

ensure their programs are “not a bottleneck in the private sector meeting demand”. If a program is well

designed with the inputs of all stakeholders, including conformity assessment bodies, it is very unlikely that

the program will create any bottleneck because the market forces for delivery of conformity assessment

services has always demonstrated the ability to fulfill demand for capacity.

Lines 392-395: This paragraph seems lost here. IFIA supports NIST’s reinforcement of OMB A-119 and the

directive for agencies to consult with USTR on “relevant international commitments for conformity

assessment”, but NIST should provide additional context or narrative to reinforce why it is a critical step in

“understanding federal law, policies and rulemaking”.

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Lines 445-447: Similar to the ABCs, it is not clear the reason why there should be an emphasis on

government laboratories in the documents. OMB Circular A-763 states that the government should not

compete with the private sector, and should instead rely on commercial sources to supply the products and

services it needs. Government laboratories, which rely on public funds, routinely compete with private

sector laboratories in direct violation of A-76. IFIA recommends that NIST reinforce in the Considerations

document (as well as in the ABCs; please see IFIA comments on the ABCs lines 360-363) the OMB A-76

policy and the need for agencies to refrain from competing with the services provided by the private sector

conformity assessment bodies in any conformity assessment activity (testing, inspection, certification,

auditing, etc.). Conformity assessment bodies have the ability to scale services, technical expertise, and

innovative technologies to provide such services in a more cost-effective and efficient manner. Taxpayers

shouldn’t have to finance activities that can be more effectively provided by the private sector.

Line 471: Replace “may be restrictive” with “should be considered”:

“(...) cost of having an inspector present during production should be considered”.

Line 566: Replace “generally” with “always”:

“(...) third-party (...) is always distinct from the first or second-party (...).

Lines 567-568: NIST includes government as one of the parties that can perform conformity assessment

activities along with first, second and third-party. This is not aligned with ISO/IEC definitions. IFIA

recommends sticking to the definitions based on the ISO/IEC 17000 series (similar in the ABCs, please see

IFIA comments on the ABCs lines 266-268, Fig 1.).

A note can be added (after the description of first, second and third-party) to elaborate that governments

have a unique role in conformity assessment activities related to establishing and enforcing regulatory

requirements and that government is sometimes considered a second party in procurement applications.

This change would be consistent with international standards definitions while still validating that

government has a unique role in conformity assessment.

Line 583: IFIA recommends replacing “A listing function is not in itself an attestation” with “A listing function

may or may not be an attestation”.

3 https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A76/a076.pdf

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Lines 602-625: This section on recognition is duplicating the content of the ABCs and IFIA recommends

that NIST consider streamlining the documents, leaving the description of the concepts to the ABCs and

focusing the Considerations on how and when is appropriate for agencies to leverage such instruments.

If NIST does include language on recognition in the documents, IFIA recommends that NIST also include

language on national treatment for conformity assessment bodies, which is an effective alternative to mutual

recognition agreements (MRAs).

National treatment can be defined as “Each Party shall accord to conformity assessment bodies located in

the territory of another Party treatment no less favourable than that it accords to conformity assessment

bodies located in its own territory or in the territory of any other Party4.” That means that CABs in the

exporting country should be authorized to test, inspect and certify certain products in accordance with the

legal and technical (standard-based) requirements that apply in the importing country. National treatment

helps facilitate trade and time-to-market since manufacturers are free to use the conformity assessment

body of their choice and location most appropriate to their business model, instead of having to select from

a restricted list of CABs in the destination market only. National treatment also gives regulators greater

confidence that requirements are met since regulators would approve CABs and/or Accreditation Bodies

directly instead of via a MRA approach.

For MRAs to be effective, they require the same standards, the same methods of conformity assessment

and the same accreditation requirements. Past MRAs have had limited success facilitating trade due to the

lack of trust in the trading partner’s quality infrastructure (standardization, accreditation, conformity

assessment, metrology) and, in some instances, have established a non-level playing field for the testing,

inspection and certification industry by adding unnecessary and burdensome administrative procedures.

Lines 628-630, footnote 21: IFIA recommends deleting “many of which do not rely on certification” since

there is no reason for adding this sentence.

Lines 734-737: IFIA recommends adding language to encourage agencies to avoid choosing a specific

edition of a standard and be more general so that the most recent edition of the standard is always

applicable. Conformity assessment bodies are required to comply with the most recent editions of the

standards by accreditation bodies and having a regulation require an older edition of the standard will cause

inconsistency and inefficiencies.

4 Trans-Pacific Partnership (TPP) Technical Barriers to Trade Chapter: https://ustr.gov/sites/default/files/TPP-Final-Text-TechnicalBarriers-to-Trade.pdf

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Line 775, footnote 24: IFIA recommends that the document be consistent with OMB A-119 terminology,

therefore, replacing “non-conformity” with “non-compliance”.

Lines 773-823 on “Determining the Confidence Point”: IFIA recommends that NIST also provide a

comprehensive set of checklists with questions for agencies to consider when deciding on a method of

conformity that best meet their confidence needs. Some questions that agencies should consider when

deciding on the appropriate method of conformity: how hazardous is the product? how likely is noncompliance? what is the industry’s track record? how much trust is there is in the supply chain? what are

the societal costs of non-compliance? what are the agency’s resources and capabilities? how effective are

the mechanisms for removing non-compliant products from the market? what are the penalties and other

deterrent mechanisms in place?, etc. IFIA offers for NIST consideration (please see Annex 1) a full set of

suggested questions and the answers that generally apply for different methods of conformity (first or thirdparty).

Lines 802-810 states: “resource costs for the agency in operating a conformity assessment program”.

When discussing cost estimates to decide on the appropriate conformity assessment model, IFIA

recommends that NIST add language reinforcing OMB A-119 policy that agencies should leverage private

sector conformity assessment instead of directly providing conformity assessment whenever possible.

Reliance on private sector allows for agencies to save scarce resources and focus its role on oversight and

supervision of a market-based approach.

In addition, agencies need to evaluate all the benefits and avoided costs of different models to all

stakeholders, including the agencies, business, and consumers. For instance, agencies should account for

the societal costs (injuries, death, property damage, loss of production, loss of salary, cost of hospitalization,

etc.) that may be avoided or mitigated with a more robust approach that relies on third-party conformity

assessment.

Agencies should also account for costs associated with post-market approach: fully funded market

surveillance, investigations, recalls, penalties, criminal charges, etc. Depending on the risks and levels of

confidence needed these post-market related costs may be considerably reduced if an agency leverages

third-party conformity assessment. For instance, in 2008, OSHA estimated that implementing a first-party

system, in lieu of the current use of accredited third parties, would cost the agency approximately $360

million annually, compared to the approximate $1 million annually required to operate the third-party

Nationally Recognized Testing Laboratory (NRTL) program5. This differences in potential costs to OSHA

5 https://www.regulations.gov/document?D=OSHA-2008-0032-0099

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are largely driven by OSHA having to fund/conduct surveillance activities versus reliance on the NRTLs

themselves.

Lines 880-881 currently reads as follows:

“generally, a requirement for independency add costs to stakeholders and overall program”

IFIA recommends that NIST cover cost aspects in a comprehensive manner. As discussed above, a

requirement for independent third-party conformity assessment (which should be based on risks and level

of confidence needed), will in general save agencies resources compared to a post-market approach,

where the agency has to fully fund market surveillance to ensure that a first-party model can be successful.

Lines 875-877: IFIA suggests adding “or the true need” after “resources” and “internally, or whether

private sector providers are appropriate” after “activities”:

“Consider whether the agency has the resources or the true need to perform the conformity

assessment activities internally, or whether private sector providers are appropriate”

Line 901-903: After objectives, IFIA suggests that NIST adds the following sentence: “nor does the use

of the least robust model always lead to program that is optimally effective and efficient for

achieving conformity assessment program goals and meeting broader objectives”:

“In conformity assessment, the use of the most independent and most robust model does not

always lead to a program that is optimally effective and/or efficient for achieving conformity

assessment program goals and meeting broader objectives, nor does the use of the least robust

model always lead to program that is optimally effective and efficient for achieving

conformity assessment program goals and meeting broader objectives.”

Lines 939-94 currently reads: “Develop the conformity assessment model (...) at an acceptable cost to all

stakeholders”. IFIA recommends that this be deleted since there is no method addressed to evaluate what

these terms mean. How does NIST define acceptable? And to whom? Any conformity assessment

program should be developed to meet agency’s need to fulfill their mandate in the most effective

and efficient manner to all stakeholders.

Lines 951-955: “SDoC is generally used when...” add after the last bullet the following new bullet: “market

surveillance activities are fully funded”.

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In addition to risk being low and there being adequate capacity to impose penalties and remove product

from the market, fully funded market surveillance is key for a successful SDoC model. The lack of a fully

funded market surveillance in a SDoC model will lead to a high incidence of non-compliant products on the

market, which can contribute to health and safety issues and other socio-economic costs. For instance, in

Europe, which relies on a first-party conformity assessment (SDoC) model for consumer products, has

acknowledged the need to “strengthen controls by national authorities and customs officers to

prevent unsafe products from being sold to European consumers”:

“There are still too many unsafe and non-compliant products sold on the EU market: as many as

32%of toys, 58% of electronics, 47% of construction products or 40% of personal protective

equipment inspected do not meet the requirements for safety or consumer information foreseen in

EU legislation. This endangers consumers and puts compliant businesses at a competitive

disadvantage”.6

The high levels of non-compliance identified by the Europeans Commission (EC) studies is corroborated

by IFIA’s market survey from 2014-20167. The survey, which reviewed small household appliances on the

U.S and EU markets, have found that products that were self-declared (mostly in Europe) presented much

higher percentage of non-compliance compared to products that were third-party certified (mostly in the

U.S.): 17% of self-declared products had safety-critical failures (high risk or fire or permanent

injury), compared to less than 1% for products with third-party certification.

This survey sheds light on the value of third-party conformity assessment in providing higher levels of

confidence in compliance with safety standards and regulations and reinforces how different avenues for

demonstrating compliance deliver different levels of assurance.

Lines 960-962 state:

“Reliance on an SDoC is considered to be a trade-friendly approach to conformity. From a

manufacturer's perspective, the SDoC allows flexibility in choosing where to have a product tested

and reduces associated testing costs and time to market”.

IFIA recommends that this statement be removed. This document should be neutral and not be promoting

a specific perspective that one method of conformity is better than another. Any method of conformity is

6 http://europa.eu/rapid/press-release_IP-17-5301_en.htm

7 http://www.ifia-federation.org/content/wp-content/uploads/IFIA_CIPC_239_2014-2016_Market_survey_report.pdf

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trade friendly as long as national treatment is provided for conformity assessment bodies. National

treatment can be defined as “Each Party shall accord to conformity assessment bodies located in the

territory of another Party treatment no less favourable than that it accords to conformity assessment bodies

located in its own territory or in the territory of any other Party8.” That means that CABs in the exporting

country should be authorized to test, inspect and certify certain products in accordance with the legal and

technical (standard-based) requirements that apply in the importing country. National treatment helps

facilitate trade and time-to-market since manufacturers are free to use the conformity assessment body of

their choice and location most appropriate to their business model, instead of having to select from a

restricted list of CABs in the destination market only.

In additional, the statement that SDoC is trade-friendly is not consistent with the language on OMB policy

Circular A-119, Revised, which states that “(...) conformity assessments conducted by private sector

conformity assessment bodies can increase productivity and efficiency in government and

industry, expand opportunities for international trade, conserve resources, improve health and

safety, and protect the environment”.

Line 961-962 and lines 969-970:

“SDoC (...) reduces associated testing costs and time to market”

IFIA recommends that this line be removed. This document should not be promoting a specific perspective

that one method of conformity is better than another. A manufacturer may have higher costs and time-tomarket regardless of which conformity assessment method is used (SDoC or third-party). In fact, many

manufacturers rely on third-party to reduce in-house compliance costs and time-to-market and gain global

market access due to economies of scale and technical expertise of conformity assessment bodies.

Many manufacturers seek conformity assessment bodies’ services to demonstrate assurance that products

are compliant across various markets at the design stage of the supply chain, which significantly reduces

costs, liability and reputational risks while allowing smooth international trade flow and global market

access. Many government agencies across the globe rely on third-party certification requirements when

higher levels of confidence and assurance are needed to protect health and safety, which at the same time

reduce the amount of resources needed to properly staff and fund market surveillance, import inspections,

and recall activities.

8 Trans-Pacific Partnership (TPP) Technical Barriers to Trade Chapter: https://ustr.gov/sites/default/files/TPP-Final-Text-TechnicalBarriers-to-Trade.pdf

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Costs are driven primarily by the regulatory requirements and not by the method of conformity. Once there

is a requirement, there is a need to demonstrate compliance with the requirements. This demonstration can

be done either in-house (where the manufacturer has to outfit labs, hire/train engineers, buy/calibrate

equipment, etc.) or by a third-party service provider. The costs to demonstrate compliance are generally

about the same whether done in-house or by a third-party. The business cost is compliance and the only

way to save costs is to not perform the required conformity assessment that supports demonstration of

compliance. In addition, the claim that different methods of conformity have different impacts on time-tomarket or increased costs in a supply chain should be based on data or empirical evidence or be removed

from the document.

Lines 964-970: While the attestation is first-party, the testing is conducted by an accredited and FCC

recognized laboratory. Therefore, this program is not a 100% SDoC as the language implies. IFIA

recommends that this language be revised to reflect how the FCC program actually operates.

Line 978 notes that “Third-party certification programs can differ greatly from one another”. Not only thirdparty programs can differ greatly from one another; all programs irrespective of the conformity assessment

method (first, second or third-party) will differ greatly from one another due to different objectives and

confidence levels needed.

Lines 979-985 state:

“The degree of confidence that can be placed in a particular certification program depends on many

factors, such as the adequacy of the product standards used; the program's comprehensiveness

(the number and types of testing and inspection methods used within the program to assess

conformity); the size of the sample and the type(s) of sampling process(es) used; the use of quality

management system requirements; the competence of the personnel involved in the program; the

adequacy of the facilities and equipment; and the nature and extent of any surveillance or followup procedures used to assure that product continues to conform. For an agency choosing to

perform as a certification body, these factors should all be addressed and implemented by the

agency.”

IFIA recommends that the document be revised to clarify that many of these factors apply to any program

(first, second or third-party) and not only to third-party certification program, as it currently implies.

Lines 1025-1026 states that “Often surveillance is used by the organization issuing an attestation (either

supplier declaration or certification) to maintain confidence that the product or service conforms to

requirements on an ongoing basis.” As stated earlier, IFIA recommends that the document be revised to

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clearly convey that there are different avenues for demonstrating compliance, and each of these

avenues deliver different levels of assurance. Supplier declaration does not typically include

surveillance and therefore should not be portrayed as similar to the third-party certification surveillance.

Certification bodies generally conduct extensive review of a product’s manufacturing process and make a

determination that the product complies with applicable standards. The certification process includes

periodic testing, inspection, market surveillance, and factory auditing. It provides assurance of ongoing

compliance throughout the entire production process with corrective actions in place if non-conformities or

issues are identified during the process. Third party surveillance activities may also include surveillance of

any Marking used as a protection against counterfeiting of Marks.

Lines 1063-1067 currently reads as follows:

“If the Federal agency conformity assessment program relies on an SDoC issued by the supplier,

the program owner should develop surveillance requirements (analogous to the surveillance

requirements that certification bodies have). Requirements can be focused on the supplier

performing surveillance activities; on the agency performing surveillance activities; or by another

organization performing surveillance activities on behalf of the agency.”

NIST states that an agency can set surveillance requirements “focused on the supplier performing their

surveillance activities”. When relying on such approach, NIST should recommend that agencies put in place

mechanisms to ensure that the supplier surveillance is actually happening. If an agency does not put in

place such mechanisms, it needs to rely on regulatory or third-party surveillance, which are impartial and

independent.

Lines 1076-1081: IFIA recommends that the OSHA NRTL example be further elaborated. The program is

a public-private partnership that relies on third-party certification to ensure products entering the market are

safe, reliable and efficient. The program helps the agency to fulfill its mission while saving the agency

resources. In 2008, the agency estimated that implementing a first-party system, in lieu of the current use

of accredited third-party conformity assessment bodies, would cost OSHA approximately $360 million

annually, compared to the estimated $1 million annually required to operate the third-party NRTL program9.

This differences in potential costs to OSHA are largely driven by the fact that OSHA would have to

fund/conduct surveillance activities instead of relying on the NRTLs themselves.

Lines 1083-1096: The CPSC example demonstrates how the agency has to combine different policy tools

and invest resources in a post-market surveillance system to fulfill its mission to protect consumer safety.

9 https://www.regulations.gov/document?D=OSHA-2008-0032-0099

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Differently from the OSHA NRTL program, which relies on third-party certification (and all the surveillance

activities are conducted by the certification bodies with OSHA focusing on oversight), the CPSC allocates

resources to conduct ongoing market surveillance not only in the ports but also after the products have

entered the market. CPSC also invests resources to manage a recall system, all of which are important

measures that need to be in place if there is no requirement for third-party certification in place.

The CPSC does have in place third-party testing requirements for children’s products, which is an

appropriate tool when used in combination with other non-compliance deterrence measures, such as civil

and criminal penalties, education of the supply chain on CPSC requirements, fully funded market/import

surveillance, and a recall system (as described above). Other market-driven aspects such as product

liability and retailers’ programs also provide further incentive for compliance.

Lines 1135-1136 notes that “The agency should consider accepting test results or attestations that are

considered beyond what is required (e.g., accepting a certification if SDoC is the requirement).” IFIA

supports such approach. Many companies go beyond the mandatory requirements and use certifications

as means to meet consumers’ expectations, protect their brands and reputation, and mitigate risks across

the supply chain. These companies should be able to fully leverage their certifications beyond what is

mandated without being required to provide addition demonstrations of compliance.

In addition, IFIA recommends that NIST includes language encouraging agencies to consider creating

systems that reward manufacturers for utilizing third-party, even if the conformity assessment

mechanism does not require them to do so. Examples of such rewards might include “green-lighting”

products with a third-party certification mark during the import surveillance screening, thereby allowing

the agencies to more effectively target shipments, or reducing/eliminating facility inspections/audits if

a company has third-party certification or inspection, etc.

Lines 1228: Add “these penalties should be designed for a deterrent effect on non-compliances”

after “policy” so that the sentence reads as follows:

“Penalties stated in regulation, Federal policy, agency policy or procurement policy; these

penalties should be designed for a deterrent effect on non-compliances.”

Line 1246: IFIA recommends that NIST includes language on reciprocity and reinforce that agencies should

establish baseline requirements for acceptance of accreditation bodies to determine if they have the

necessary abilities and technical expertise to assess third-parties to US regulatory requirements and the

appropriate standards. It is therefore the responsibility of the regulatory agency to investigate, review, and

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verify the qualifications of each accreditation body prior to acceptance as this will have a significant effect

on the qualifications of the conformity assessment service providers.

While IFIA recognizes that the mission of regulatory agencies does not include trade policy issues, it is

necessary for agencies to take into account when accepting conformity assessment results from nondomestic conformity assessment bodies, whether there is a system of equal recognition and equivalent

market access in their country for the acceptance of the work of properly accredited U.S. based conformity

assessment bodies. This principle of reciprocity provides equivalent market access and will help insure

equal treatment while fostering a level playing field for conformity assessment bodies and manufacturers

across the globe.

Lines 1250-1252 states:

“to accept the results of conformity assessment procedures in other WTO member countries,

provided it is satisfied that those procedures offer an assurance of conformity equivalent to

its own procedures”.

In applying the OMB A-119 guidance as stated above, IFIA recommends that NIST reinforces that

agencies need to ensure equivalence of the method of conformity when accepting results from

other countries, since different methods provide different levels of assurance. Many factors are

involved in the decisions as to the appropriate standards and the confidence level of the type of

conformity assessment used to demonstrate compliance. These include seemingly unrelated issues

such as individual legal systems and the ability to enforce requirements.

If a higher confidence level of conformity assessment has been applied using the adopted/recognized

standard, then it would make sense to accept this more rigorous form to reduce duplicative

requirements on manufacturers. Conversely, it would not be prudent for regulatory agencies to accept

compliance as being equivalent if the method of conformity was less rigorous. For example, if a

Federal agency required accredited testing but the industry is already using accredited product

certification, then the agency should be allowed to accept product certification to fulfill its regulatory

requirements. However, accrediting testing would still remain the floor and still meet regulatory

requirements.

Lines 1266-1267: Remove “costs”, “development time” and “capacity”’ so the revised sentence would

read as follows:

“These include potential impacts to consumers or users, supplier and conformity assessment

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organizations”.

Line 1310: Add “or accreditation” after “assessment”:

“(...) without additional assessment, or accreditation, of the organizations performing the

conformity assessment activities.”

Lines 1446-1451:

“Metrics and data that indicate how conformity assessment organizations are performing. For

example: Are conformity assessment organizations consistent in pass/fail results, attestation

decisions, etc.? Are the conformity assessment organizations applying program guidance or

requirement interpretations consistently? Is any single organization an outlier and if so, why? As

the market changes, are conformity assessment organizations still meeting requirements and

operating effectively?”

All these metrics are assessments undertaken as part of an accreditation program. Agencies must

define accreditation requirements that meet their confidence levels.

Lines 1464-1465: Replace “without overburdening manufacturers” with “in an efficient and effective

manner”:

“oversight goals are met in an efficient and effective manner”.

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ANNEX 1

Considerations in Selecting Methods of Conformity as Part of Regulatory Scheme Framework

1. Questions for agencies to consider when deciding on a method of conformity that best meet

their confidence needs

When a decision has been made to regulate (or recognize/reference standards) to address a specific

hazard or risk, how to choose the appropriate method of conformity? How does the role of government

change under each method?

In general, the requirement for a particular level of rigor in the conformity assessment process is determined

by the risks associated with the product, process, or service and its scope of use. The appropriate

conformity assessment mechanism is also determined by other market factors, such as the legal system

and the general philosophy of pre-market conformity assessment versus a fully funded post-market

surveillance system. The confidence level needed is based on the risk of non-compliance and what marketdriven mechanisms exist as mitigation tools for non-compliance. Part of a full analysis would include the

pre-market and post-market structure that would be required. The choice of that structure has implications

for costs of related government infrastructure, socio-economic costs, costs of establishing and sustaining

technical competency levels, and capacity of those providing the service.

Below is a table that summarizes a few questions that agencies should consider when deciding on a method

of conformity that best meet their confidence needs with the answers depending on the method of

conformity. The answers below are not always this clear cut, but represents what is generally the

case for each method of conformity.

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QUESTIONS: FIRST-PARTY THIRD-PARTY

1. Is a high level of confidence required? No Yes

2. Is the perceived risk high? No Yes

3. Are products regulated primarily manufactured in countries with a

history of risk factors and other issues?

No Yes

4. Are products manufactured in complex and fragmented supply chains? No Yes

5. Is there a documented history of industry compliance? Yes No

6. Is there a documented history of industry non-compliance? No Yes

7. Is there evidence that product liability is an effective deterrent? Yes No

8. Do regulatory authorizing/statutory provisions provide severe penalties

and an effective deterrent?

Yes No

9. How strong is the need for impartiality and independence? Low High

10. Are there voluntary, market driven schemes that address confidence

needs?

Yes No

11. Are there relied upon accepted international schemes that can be

leveraged?

Yes, and sufficient to

meet confidence

needs

Yes, but insufficient

12. What are the societal risks of non-compliant products? Low High

13. Who bears the costs of market surveillance? Primarily

governments

Private sector

14. How likely is the need for recall or corrective action? More likely Less likely

15. How effective is the model in supporting anti-counterfeiting

enforcement?

Low High

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2. Methods of conformity agencies can choose to satisfy their confidence needs

In general, there are three approaches to conformity assessment: First-Party (manufacturer), SecondParty (purchaser or user) and Third-Party (independent entity).

First-Party Conformity Assessment: “Performed by the person or organization that provides the object”

10, that is, the supplier or manufacturer demonstrates that a product or service fulfils specified

requirements, and it is typically used when there is a lower level of risk associated with non-compliance

and with the product. In First Party Conformity Assessment, the resulting statement of conformity is

commonly referred to as the Supplier’s Declaration of Conformity (SDoC).

For a First-Party conformity assessment model to work:11

 The risk of noncompliance must be low;

 The risk of the product must be low;

 There is confidence that manufacturers understand the technical, regulatory and market

requirements and has satisfactory control over their supply chain;

 There are adequate penalties for placing noncompliant products in the market, which include - but

are not limited - to:

o civil and criminal penalties

o product recall, and/or

o product bans; and

 There is a fully-funded post market surveillance system in place that quickly and effectively

removes noncompliant products from the market in order to avoid injury and societal costs. A post

market surveillance system should consist of:

o mechanism for customer complaints,

o marketplace surveillance and testing,

10 https://www.iso.org/standard/29316.html 11 ACIL: https://c.ymcdn.com/sites/www.acil.org/resource/resmgr/imported/ACILsDoCPositionPaper.pdf

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o factory surveillance and testing, and

o regular independent audits of individual manufacturers’ declarations of conformity.

A fully-funded post market surveillance system is a key requirement for a first-party conformity assessment

model to be successful and avoid a high incidence of non-compliant products on the market that can

contribute to health and safety issues and other socio-economic costs.

Second-Party Conformity Assessment

“Performed by a person or organization that has a user interest in the object” 12, that is, the end user or

entity acting in the interests of the end user, or an individual or group whose primary interest is in fulfilment

of requirements demonstrates for itself that specified requirements are fulfilled.

Second parties may not always have business models that allow them to maintain the infrastructure,

processes and technical competence to cost-effectively take advantage of this approach. Also, costs of

goods and services can increase if suppliers face a high number of demands from individual second parties

each carrying out their own conformity assessment. Therefore, second parties often rely on third-party

conformity assessment to fulfil their confidence needs in a cost-effective manner.

Third-Party Conformity Assessment

Performed “by a person or body whose interests in the product are independent from those of first parties

and whose interests in fulfilment of requirements are independent from those of second parties.”13

Independent third-party conformity assessment bodies (CABs) may be accredited and regularly assessed

by accreditation bodies as proof of qualification (competence) to provide services as a result of accreditation

to international ISO/CASCO standards such as: ISO/IEC 17025 for testing, ISO/IEC 17020 for inspection

and ISO/IEC 17065 for certification. This accreditation also includes an in-depth review of their documented

management systems used to assure ongoing compliance with these international standards. The

accreditation bodies may be either government bodies, recognized accreditation bodies operating under

international guides, or a combination of both.

Third-party is widely relied upon in many markets when14:

12 https://www.iso.org/standard/29316.html 13 https://www.iso.org/standard/29316.html 14 ACIL:

http://c.ymcdn.com/sites/www.acil.org/resource/resmgr/imported/The%20Value%20of%20Third%20Party%20Certification.pdf

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 There may be a higher risk associated with non-compliance;

 There may be a higher risk from products;

 There is need for an independent demonstration to the supply and demand chain such as

consumers, manufacturers and regulators that a product fulfils specified requirements;

 There is need for higher levels of confidence and assurance of compliance with safety, health

or environmental requirements;

 Manufacturers seek to reduce in-house compliance costs or apply third-party as an added value

to their own quality and conformity assessment procedures to gain global market access and

protect their brands and reputation; and/or

 There are limited government resources to fully fund market surveillance systems.

3. Third-party conformity assessment

Within third-party there are various options; in some cases, there will be a need for a full certification and

others third-party testing only. Sometimes the agency may need only facility audits or inspections or a

combination of different procedures. Again, it will depend on various factors and the levels of confidence

needed will drive the decision. For instance, if the agency has no resources for funding post-market

surveillance and the risks associated with the product and with non-compliance are high, the agency might

consider full certification. If the risks of non-compliance are low, there are liability laws and penalties that

function as effective deterrents, and there is adequate post-market surveillance, then the agency might

consider SDoC. If the situation is somewhere in between, perhaps third-party testing requirements might

be an effective tool.

Below are a few examples to illustrate third-party testing and third-party certification:

Third-party Testing:

Labs receive samples from

manufacturer

Labs conduct testing against

standards

Labs produce test report with

pass/fail result

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When conducting testing only, the laboratory role is limited to receiving samples, testing against standards

and reporting pass/fail results. Labs have no control of, nor information about:

a. Whether manufacturers are testing “golden samples”;

b. Any material changes by the manufacturers when receiving a request from manufacturers to

transfer data from old test reports or from reports issued by other labs;

c. Whether the sample is representative of the entire production;

d. Whether manufacturers have reasonable testing programs in place;

e. Whether labs meet the applicable accreditation requirements when receiving test results from

reports issued by other labs;

f. Whether manufacturers’ supply chains ensure traceability and there are documentation controls in

place; and

g. Whether there is a system to offer testing to maintain continuing compliance

The U.S. Consumer Product Safety Commission (CPSC) third-party testing requirements for children’s

products is an example of the use of third-party testing as one of the tools in the regulator’s toolbox to

ensure products are safe. It is used in combination with other non-compliance deterrence measures, such

as civil and criminal penalties, market and import surveillance, education of the supply chain on CPSC

requirements, and a product recall system. Other market-driven aspects such as product liability and

retailers’ programs also provide further incentive for compliance.

Third-party Certification:

Certification bodies conduct extensive review of a product’s manufacturing process and make a

determination that the product (or system, process, person) complies with applicable standards. The

certification process includes periodic testing, inspection, market surveillance and factory auditing. It

provides assurance of ongoing compliance throughout the entire production process with corrective actions

in place if non-conformities or issues are identified during the process.

The Environmental Protection Agency (EPA) Energy Star program is an example of a voluntary publicprivate partnership that relies on independent third-party certification to ensure ongoing compliance and

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compliance were identified by an investigation from the Government Accountability Office (GAO). Reliance

on third-party certification helps maintain consumer trust in the Energy Star designation and improve

oversight of the program while allowing the agency to save scarce resources since evaluation and market

surveillance is performed by the private sector.

Below is an overview of the certification process:

Surveillance and

renewal

Certificate

issuance

Approval

process

Sample

selection and

Factory audit testing

Documentation

evaluation Corrective

Actions

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