After “…products labeled as ‘100 percent organic,’ if processed, must be processed using”, delete “no processing aids”, and insert, “100 percent organic processing aids.”
Rationale: As written, the use of organic processing aids in the “100 percent organic” category is not allowed. While the intent of USDA’s proposed language would seem to be preventing use of processing aids under the assumption that all processing aids are both undesirable and not organic, some currently marketed organic products actually use organic materials as processing aids. One such organic processing aid is organic rice hulls used as an aid required to produce a consistent fruit pulp mash. “100 percent organic” products should not be penalized by demotion to the “organic” category, when even their processing aids are organic.
77. New subsection 205.301(f)
Create a new subsection 205.301(f), to read:
“(f) All ingredients or additives, whether organic or non-organic, identified as “100% organic” or “organic” must satisfy the conditions of 205.301(e).”
Rationale: As currently written, this Section allows non-organic ingredients used in products labeled “organic” and “made with organic ingredients” to be processed using processing aids not approved on the National List and to contain added sulfites, nitrates, or nitrites. This is inconsistent with the NOSB Recommendation, “General Food Labeling Standards”, (Austin, October, 1995, Sligh, p. 54), which prohibits such non-organic ingredients.
Replace “must be rounded down to the nearest whole number” with “may be rounded down to the nearest tenth of a whole number.”
Rationale: For some products, such as milk, the additional percentage of Vitamin D is so small that 99% might actually be misleading to the consumer, suggesting that as much as 1% of the product is non-organic when that is not the case. Using tenths of a percentage would make clear in these instances that only a very small amount of non-organic ingredient is present.
79. New subsection 205.303(c)
Insert a new section 205.303(c) to read as follows:
“(c) Agricultural products in packages described in § 205.301(a) and (b) must not:
(1) Use the word “organic” as a modifier in a product name on the principal display panel to modify an ingredient which is not organic.”
Rationale: Section 205.303 does not address use of the word “organic” as a modifier in a product name on the principal display panel when the ingredient modified is not organic - e.g. “Organic Cherry Sweets,” where the product contains 95% organic sweetener, but the cherry is a natural flavor, but not an organic ingredient; or “Organic Chocolate Ice Cream,” where the ice cream contains 95% organic ingredients, but the chocolate is not organic. Such labeling is misleading to consumers, and needs to be specifically prohibited in this rule.
After “Does not list more than three organic ingredients” add “or three organic ingredient groups (such as “organic vegetables”), as long as all the ingredients in the group are organic.”
Rationale: It is currently common practice to label groups of ingredients on the principal display panel, instead of listing each individual ingredient. An example is the principal display panel labeling of “made with organic vegetables” instead of “with organic broccoli, corn, peas, and zucchini”. This group labeling is used when all the vegetables in a product are organic. Other examples are “made with organic pasta” or “made with organic crust”.
There are several reasons for using group labeling: 1) all members of the food class must be organic; 2) commonly, there may be more than three individual organic ingredients in an organic group of ingredients; 3) the group ingredient labeling on the principal display panel or other panel takes up less space than listing three (or more) individual ingredients; 4) group ingredient labeling is accurate, descriptive, and not misleading. In fact it more accurately describes the organic content when compared to labeling only 3 organic ingredients out of a list of many more organic ingredients in a product; and 5) often there are substantially more than three organic ingredients in a product, and group labeling allows a more accurate and concise principle display panel description of the range of organic ingredients in that product.
Replace 306(b) with the following:
“(b) If not required under other Federal labeling regulations, non-retail containers used to ship or store raw or unprocessed agricultural produce labeled as organic ingredients must be shipped in containers clearly identified with the grower’s name and the certification agent or are linked to and accompanied by appropriate documents that provide this information that maintains the audit trail. Other non-retail containers used to ship or store raw or processed agricultural ingredients labeled as containing organic ingredients, other than produce, must display the production lot number and certifying agent or be linked to and accompanied by appropriate documents that provide this information to maintain the audit trail.”
Rationale: This is consistent with AOS Section 220.127.116.11 and is a reflection of industry requirements and practices. It is fundamental to keep the audit trail intact and to assess compliance with recordkeeping requirements. It would not place undue burdens on producers, processors, or handlers, and would facilitate the certification process.
Change the wording of 205.310(b), Figure 1 to read:
“Certified Organic - USDA Approved”
Rationale: Proposed wording of the seal, “USDA Certified Organic,” indicates that a product carrying the seal was certified by the USDA, when in fact the USDA is the accreditation body, not the certification body. (An accreditation body assesses and regulates the numerous certification bodies, which are the certifying agents who regulate an operation’s certification.) The proposed wording violates the International Organization for Standardization (ISO) Guide 61, “General Requirements for Accreditation Bodies,” which prohibits an accreditation body’s mark from being used on a product to denote or imply certification by the accreditation body. ISO Guide 61, Section 2.4.2 states:
“The accreditation body shall not allow use of its mark or logo in any way which implies that the accreditation body itself approved a product, service, or system certified or registered by an accredited body.”
It is critically important that the USDA accreditation program be structured so as to comply with international norms for accreditation bodies, contained in ISO Guide 61. In doing so, the wording of the USDA seal should be changed to “Certified Organic - USDA Approved”. Also acceptable are “USDA Accredited - Certified Organic,” or “Certified Organic, USDA Standard”.
Subpart E - Certification
205.404(b)(2) Rewrite as:
“Effective date of certification and annual certification renewal date for current certification period.”
Rationale: The rule should require an annual certification renewal date (or expiration date) on all organic certificates. Numerous State laws and private certifying agent standards require annual certification. It is critically important for the marketplace, including manufacturers, distributors, brokers, and retailers, to know that the products they buy are produced under a valid certification. This information is also fundamentally important to inspectors and certifying agents as they assess if ingredients purchased, including bulk commodities, feed, and processing ingredients, were produced by and operation with a valid organic certification. Without an expiration date on the certificate, there is no way of knowing. This is consistent with OTA’s original position on this issue, but NOP responded that this change was not included because:
“We believe that annual expiration of a certificate would place undue burden on certifying agents and certified operations.” (65FR 13567)
We strongly dispute this statement, since this is certainly not a burden when it is the prevailing system of operation currently in use, and is requested by the industry. Certifying agents can and do issue extensions for an expired certificate if it expires while the review and renewal process is in process.
The preamble states further that under this regulation:
“annual expiration is inconsistent with the fact that an operation’s certificate does not expire. In fact, once an operation is certified as an organic operation, its certification remains in effect until surrendered by the certified operation or suspended or revoked by the certifying agent…” (65FR 13567).
The preamble goes on to explain that applicants will be ensured of updated certificates from the annual update process, but it fails to address the issue of how to provide proper notification to inform the public of a “surrendered, suspended, or revoked” certification. Buyers and certifiers evaluating products need a readily accessible way to identify a valid certificate, and will not be able to determine whether a certificate is up to date without some reference to the required annual renewal date. The only way that buyers would know if a producer is in good standing would be to check with the certifier for every certificate or if the USDA were to publish a continually updated list of certified parties. This will add a great deal of unnecessary burden to the system. Certifiers will also have to assume an extra burden to track and send reminders to clients informing them of their update requirements, and rely on the use of notice of non-compliance rather than a simple annual certification renewal date to achieve timely continuation of certification.
Currently, federally administered PACA licenses for produce brokers do contain an expiration date. The states of Texas, Washington, and Maryland also rely on expiration dates on their organic certificates.
Insert a new subsection 205.404(b)(4) and renumber the later sections.
“(b)(4) Number of livestock of each species produced by the certified operation;”.
Rationale: Requiring the number of livestock to appear on the certificate is important
in the audit trail process for a buyer of certified organic livestock and/or livestock products to be assured that more animals or products are not being sold than are certified. Adequate record keeping for the identification of livestock is required in other parts of the rule including 205.236(c) and 205.238(c)(7), and this addition to 205.404 would carry the information through to the certificate.
Insert a new subsection 205.404(b)(5) and renumber the later section.
“(b)(5) The specific location of each certified organic field and handling operation; and”.
Rationale: This is consistent with AOS 18.104.22.168 and 22.214.171.124. This was debated thoroughly during the AOS process, and the language, "List of production locations and/or facilities certified," was ratified by the OTA Board. It is important that buyers and certifying agents know the locations of certified organic fields and facilities, and know the approximate quantity of organic production for which the operation is certified. This information should be stated on the certificate. Based on research conducted on behalf of OTA’s Certifiers Council, a great deal of variation exists in terms of organic certificate content. Setting a requirement for identifying certified organic fields and handling operations will help bring consistency and transparency to the information contained on organic certificates.
Insert a new subsection 205.406(e) to read:
“(e) If the information as required in 205.206(a) is not supplied to the certifying agent by the annual date as specified by the agent on the certificate, the certification will be automatically suspended.”
Rationale: Section 205.404(b)(2) must require an annual certification renewal date on all organic certificates. See rationale provided in OTA comment #83 above. For consistency, a new section 205.406(e) needs to be inserted to require applicants to supplied necessary information prior to their certification renewal date, or face suspension.
87. New subsection 205.406(f)
Insert a new sub-section (f) in 205.406:
“(e) If the accreditation of a certifier is revoked or suspended for any reason, USDA shall:
(i) immediately notify all growers, handlers, processors or other parties certified by said agent, and,
(ii) allow any entity which has been certified by said agent to use current market labels for a maximum period of 12 months, provided that the certified entity has applied to another USDA-accredited certifying agent within three months of the affected party’s notification of the loss of accreditation of their former certifying agent.”
Rationale: There are no provisions in the proposed rule to protect operations certified by a certifying agent which does not qualify in the first group of accredited certifying agents. The USDA has stated that under the proposed rule, these operations would no longer be certified, and could not sell their product as organic, until they had been certified by an approved agent. There must be a safety net in the final rule to protect these operations from decertification. Please refer to NOSB Phase-in/Implementation Recommendations. (Orlando, April, 1995, Sligh, pp. 81-83)
Subpart F - Accreditation
88. New subsection 205.500(c)(3)
Add a new Section 205.500(c)(3):
“(3) The foreign certifying agent is accredited by an accreditation body recognized by the USDA, as defined by an equivalency agreement negotiated between the USDA and the accreditation body.”
Rationale: As currently drafted, section 205.500(c) allows for no recognition of private sector standards or conformity assessment (accreditation) activities.
Section 205.500(a) allows the Administrator to accredit foreign certifying agents. Section 205.500(c) allows for the approval of a foreign certifying agent’s non-USDA accreditation only if the certifying agent is accredited by a foreign government whose standards and accreditation meet the Act, or have been deemed to be equivalent to the Act. No provisions are made for recognition of a foreign certifying agent accredited by a private sector accreditation body.
Unless amended, the proposed rule discriminates against, and places undue burdens on, producers and certifying agents located in developing countries which do not have government regulations, since the certifying agents would have to be accredited by the USDA, when well-established private sector accreditation systems already exist. This barrier also creates reciprocity difficulties for US-based certifying agents whose certified operators distribute products certified by foreign certifiers or use such products as ingredients in processed products.
The proposal as stated ignores the NOSB recommendation, (Santa Fe, June, 1994, Sligh, pp. 40-42), which allows for recognition of private sector accreditation by an “International Organic Standards Organization.”
The proposal also ignores the National Institute of Standards and Technology Act, (15 U.S.C. 272(b) - Public Law 104-113, passed March 7, 1996), which directs regulatory agencies, to coordinate Federal, State and local technical standards activities and conformity assessment activities with private sector technical standards activities and conformity assessment activities, with a goal of eliminating unnecessary duplication and complexity in the development and promulgation of conformity assessments requirements and measures. NIST, though not explicitly directed at the USDA’s National Organic Program, sets a requirement that regulatory agencies are to utilize private sector standards and conformity assessment services wherever possible. As stated, existing private sector accreditation is ignored by the proposal.
The proposal also ignores Office of Management and Budget Circular # A-119, which directs government agencies to recognize and cooperate with voluntary standards activities, both domestic and international. OMB Circular #A-119 states:
“Government functions often involve products or services that meet reliable standards. Many such standards, appropriate or adaptable for the Government’s purposes, are available from private voluntary standards bodies. The adoption of voluntary standards, wherever practical and appropriate, eliminates the cost to the Government of developing its own standards. Adoption of voluntary standards also furthers the policy of reliance upon the private sector to supply Government needs for goods and services…. Voluntary standards that will serve agencies’ purposes and are consistent with applicable laws and regulations should be adopted and used by Federal agencies.”
OMB Circular #A-119 provides a legal directive to agencies such as the USDA to rely on the private sector for standards setting and conformity assessment activities.
Furthermore, the Codex Alimentarius Commission’s “Guidelines for the Production, Processing, Labeling, and Marketing of Organically Produced Foods” state, “for organic production, the competent authority may delegate the accreditation function to a private body.”
Clearly, there is legal precedence, NOSB support, and international guidance which allow for, and encourage, recognition of private sector accreditation bodies.
The determination of equivalence of a private sector accreditation system could represent a substantial savings in cost to the US National Organic Program, particularly in the first eighteen months when costs to accredit initial certifying agent applicants are proposed to be supported out of authorized funds. Such savings could be directed toward other pressing needs, such as enforcement, development of program manuals, and review of needed materials.
Rewrite 205.501(a)(5) as follows:
“205.501(a)(5) Ensure that its
responsibly connected persons, committees, employees, and contractors with inspection, analysis, and decision-making responsibilities have sufficient balance of interests and expertise in organic production or handling techniques to successfully perform the duties assigned.”
Rationale: It will be important for membership organizations to demonstrate that a clear “firewall” exists between those involved in decision–making and the volunteer board members responsible for organizational oversight. In this scenario, the farm of a member of the board could be certified, but that of an executive director, staff member administrator, or other directly supervising the decision makers must be free from conflict of interest.
The ISO-65 Guide handles this issue in section 4.2(n) and provides the concept of managing conflict of interest by providing a “balance of interest” in the decision making body:
“In particular the certification body shall: (n) have formal rules and structures for the appointment and operation of any committees which are involved in the certification process; such committees shall be free from any commercial, financial and other pressures that might influence decisions; a structure where members are chosen to provide a balance of interests where no single interest predominates will be deemed to satisfy this provision;”.
This concept should be incorporated to improve the proposed rule, and strengthen the makeup of volunteer boards.
Rewrite 205.501(a)(11)(i) as follows:
“(a) A private or State entity accredited as a certifying agent under this subpart must:
(11) Prevent conflict of interest by:
(i) Ensuring that certification decisions are made by parties who have no commercial interests in the outcome of the decision, including an immediate family interest or the provision of consulting services, and are not directly supervised by responsible parties with such commercial interests, within the 12 month period prior and 12 months after the application for certification;”.
Rationale: Section 205.501(a)(11) addresses conflict of interest and contains several problems. Section 205.501(a)(11)(i) prevents a certifying agent from certifying an operation if the certifying agent, all “responsibly connected parties,” or “immediate family” members have or have held a commercial interest in the operation. Since the definitions of “responsibly connected” and “immediate family” are quite broad, all employees, board members, committee members, inspectors, etc., would be prohibited from being certified by the same agency they are active in. This is beyond the requirements of ISO Guide 65, which, in Section 5.2.2, states that personnel involved in the certification process must “comply with the rules defined by the certification body, including those relating to confidentiality and independence from commercial and other interest, and declare any prior and/or present association on their own part, or on the part of their employer,” with the operation seeking certification. They may still be certified by the agent, however.
While it is critical that a firewall be maintained between certification decisions and all parties with commercial interests in the outcome of the decisions, the proposed language goes too far and places an undue burden on farmer-run and membership-based certifying agents and the operators they serve. If implemented as written, it would mean the end to regional certifying agents which rely on the involvement of their members for their existence. Of the 6,888 certified parties identified in the 1999 US Organic Certifiers Directory, published by the Organic Farming Research Foundation, OTA estimates that 5,251 or 76% of certified operations in the US are currently served by agencies that would not meet this requirement. A successful implementation of the proposed organic rule will not be possible if these experienced agencies, including those that are currently internationally recognized as ISO-65 approved and/or IFOAM accredited, are no longer able to operate.
The exclusion of ability to certify “responsibly connected” parties does not acknowledge the indirect role most board of directors play in the functioning of membership based certification agencies. Generally, boards of directors provide oversight, strategic planning, and policy direction for their agencies. Actual certification decisions are generally made by either staff or volunteer review committees. Board members, although ultimately responsible for the activities of the organization, are not involved in direct supervision of personnel (other than an executive director) or volunteers. Certification agents should be able to demonstrate their ability to segregate these functions clearly in their application for accreditation. OTA supports the addition of the requirement of a disclosure statement for responsibly connected parties in section 205.501(a)(11)(v). This requirement, along with clear disclosure of personnel policies, can address the concerns expressed by NOP that
“the certifying agents control over the employment of an agent’s employee makes it unreasonable to expect an employee of a certifying agent to impartially carry out the employee’s duties when the certifying agent or a responsibly connected party of such agent has an interest in the applicant.” (65 FR 13590)
Section 205.501(a)(11)(i) should be changed to reflect the desired outcome, without prescribing organizational structure. The goal is to prevent parties who have, or have had, commercial interests in the outcome of a particular decision, from making a decision, or supervising a decision maker on that case.
After “application for certification”, add the phrase “and the 12 months following a certification decision”. Also, add a new section 205.501(a)(11)(ii)(a):
“(a) If a conflict of interest is identified within 12 months of a certification decision, certifying agents must reconsider the application and may re-inspect if necessary.”
The revised section would read as follows:
“205.501(a) A private or State entity accredited as a certifying agent under this subpart must:
(11) Prevent conflict of interest by:
(ii) Excluding any person, including contractors, with conflicts of interest from work, discussions and decisions in all stages of the certification process and the monitoring of certified production or handling operations for all entities in which such person has or has held a commercial interest, including an immediate family interest or the provision of consulting services with in the 12 month period prior to the application for certification and the 12 months following a certification decision.
(a) If a conflict of interest is identified within 12 months of a certification decision, certification agents must reconsider the application and may re-inspect if necessary.”
Rationale: Section 205.501(a)(11)(ii) provides a timeframe for use in defining the concept of conflict of interest. As OTA has commented previously, the OTA’s Certifiers Council addresses the time frame for conflict of interest as follows:
“Between the certifying organization and the inspected party:
The members of the certification organization who are in any way determining the status of the inspected party’s organic certification must have no business transactions with the inspected party for one year before or one year after the certification. Failure to comply with above must require additional review or inspection.” (OCC Conflict of Interest Policy, January 1, 1999.)
This policy also addresses the problem of conflict after a decision is made, (for example, a “revolving door” whereby decision makers are hired by the client after a decision is rendered). If such conflict develops after a decision is made, the application would need to be reconsidered by parties that do not have such a conflict. NOP addressed this comment (65 FR 113580) by stating that they did not consider the post-certification actions of a former employee or responsibly connected party to be relevant as they shall have severed their relationship to the certification agency. OTA feels that to prevent the appearance of conflict of interest, a decision must be reconsidered, and possibly re-inspected, if decision makers or inspectors develop a conflict of interest in the 12 month post-certification period.
Rewrite Section 205.501(a)(11)(iii) as follows:
(iii) Not permitting any employee, inspector, contractor, or other personnel to accept payment, gifts, or favors of any kind, other than prescribed fees, from any business inspected, except that a certifying agent that is a not-for-profit organization with an Internal Revenue Code tax exemption, or in the case of a foreign certifying agent a comparable recognition of not-for-profit status from its government, may accept voluntary labor from certified operations for all of its activities, and may accept gifts and contributions to its programs not directly related to its certification activities;
Rationale: Section 205.501(a)(11)(iii) would prevent certifying agents which are organized as not-for-profit organizations from accepting charitable donations for the portions of their programs which are not directly related to certification. This section should be changed to prevent gifts and contributions only to the certification program: for example, some membership based organizations are active in collecting donations for charitable food pantry distribution or educational seminars.
93. New subsection 205.501(a)(11)(v)
Insert a new Section 205.501(a)(11)(v) with the following language, and change the current 205.501(a)(11)(v) to 205.501(a)(11)(vi):
“205.501(11)(v) Ensuring that each decision on certification is taken by a person(s) different from the person(s) who carried out the inspection.”
Rationale: The proposed rule does not provide an important distinction required by IS0-65, section 4.2(f), which reads:
“The certification body shall ensure that each decision on certification is taken by a person(s) different from those who carried out the evaluation.”
It is important to preserve the role of inspector as independent and free from pressure or conflict from the applicants. Inspectors must gather facts in an objective and non-judgmental fashion. Inspectors cannot be certification decision makers. This is a critical component for transparency and compliance with international norms.
94. New subsection 205.501(a)(12)
Insert the following new subsection 205.501(a)(12), and re-number the subsequent sections:
“(12) Make its certification services available to all applicants whose activities fall within the certifying agent’s accredited field of operation;”
Rationale: Section 205.501(a) does not require certifying agents to provide certification services to all applicants. In order to be consistent with ISO Guide 65, Section 4.1.2, language is needed requiring certifying agents to provide services to all qualified applicants.
ISO 65, 4.1.2 states, “The certification body shall make its services accessible to all applicants whose activities fall within its declared field of operation.”
In order for reciprocity to function, it is imperative that certifying agents provide services to all applicants. This is especially important once certification is mandatory, and certifying agents are accredited by the USDA to implement the rule.
Current section 205.501(a)(12) requires certifying agents to accept the certification decisions of all other USDA-accredited certifiers. OTA support this position. This in no way conflicts with certifying agents’ abilities and rights to control their own licensed trademarks, logos, and seals, and to set contract specifications for use of those licensed trademarks, logos, and seals. This is parallel to the provision that State programs that have additional requirements for use of their seal must still accept all products certified by USDA accredited certifiers.
OTA stands by its initial comments on the first proposed rule (April, 1998):
“OTA is strongly in favor of mutual recognition between accredited certification programs, indeed this is seen as a key benefit of the establishment of the National Organic Program. Guaranteed reciprocity should be established between certification agencies after implementation of the Final Rule. OTA urges the USDA to complete the initial round of site review promptly to facilitate full confirmation of accreditation in a timely manner. The issue of liability of certification agents for ingredients certified by other agencies is of concern, and OTA suggests the USDA clarify its role in the responsibility for such liability, if agencies are to accept all USDA certified products as equivalent to their own.”
OTA does not find that the USDA has addressed this issue of liability for ingredients certified by other USDA accredited certifiers. In this rule, USDA has also proposed that certifiers must verify certain claims about non-organic ingredients in “made with organic ingredients” products, which potentially increases liability to certifiers. For example, if a multi-ingredient product labeled as containing greater than 50% organic ingredients should be rejected by a buyer due to presence of non-organic ingredients produced using “excluded methods” (genetic engineering), USDA must be prepared to extend protection to certifiers who have in good faith accepted this product from another accredited certifier.
Amend the text, to read:
“(2) Limits the use of its identifying mark only to operators who have entered into licensing agreements with contract specifications which clearly establish the conditions for the use of its identifying mark.”
Rationale: Section 205.501(b)(2) prohibits private certifying agents from requiring “compliance with any production or handling requirements other than those provided for in the Act and the regulations in this part as a condition of use of its identifying mark.” The proposed language constitutes a violation of commercial free speech, and has no statutory basis. There is no enabling language in the Organic Foods Production Act for this provision. The only justification given in the preamble is that “a stated purpose of the Act is to assure consumers that organically produced products meet a consistent national standard.” (FR 13582) There is no contradiction between allowing certifying agents to control their own seals and maintenance of a consistent national standard. All certifying agents will be accredited to a consistent national standard. None will be allowed to have lower standards. Reciprocity at the national standard level will be mandatory, as stated in current section 205.501(a)(12), which OTA supports.
The seals of certifying agents have been used for many years. They have established market identities, and the certifying agents have intellectual property rights which would be violated if the rule is implemented as proposed. The right of private certifying agents to control their own seals was recognized by the NOSB, (Santa Fe, June, 1994, Sligh, p. 5), which stated:
“It is recognized that some private certifying agents have established programs to address specific philosophies and/or regional considerations, and may wish to include requirements for the awarding of the certifying agent’s seal that are supplemental to the standards promulgated in the OFPA. Such requirements shall not be in conflict with the National Organic Standards. Supplemental requirements shall not preclude the certification to OFPA standards of producers and handlers who do not seek to utilize the private agent’s seal.”
ISO Guide 65, 14.1 states, “the certification body shall exercise proper control over ownership, use, and display of licenses, certificates, and marks of conformity.” The proposed rule, as stated, contradicts this ISO requirement.
Section 205.501(b)(2) must be reversed to allow certifying agents to issue licensing agreements or certification contracts with “contract specifications,” in order for certified operators who sign licensing agreements and comply with the specifications to use the certifying agent’s seal. This allows certifying agents to maintain control over their licensed trademarks, and prevents a violation of commercial free speech.
Section 205.501(c)(2) requires accredited certifying agents to provide "reasonable security" to the USDA. The amount is unspecified and its affordability is of concern, especially for regional, membership based certification programs.
OTA commented in 1998:
“OTA requests that the USDA provide a better indication of what “reasonable security” might entail. This information will be needed by all agents seeking accreditation so that they can evaluate their costs to apply. The formula should be published for public comment through the rule making process.”
This critical concern has not been addressed.
Either delete the words “private entity”, or else insert the words “or State” after the word “entity.”
Rationale: The last sentence in section 205.507(d) states, “A private entity certifying agent whose accreditation is revoked will be ineligible for accreditation for a period of not less than 3 years following the date of such determination.” This provision appears to discriminate against private certifying agents, since ineligibility of State certifying agents is not addressed. The text needs to be amended as suggested above to treat private and State certifying agents equitably.
Delete “or within a reasonable period of time after” from the first sentence of this section.
Rationale: As written, this section states “An initial site evaluation of an accreditation applicant shall be conducted before or within a reasonable period of time after issuance of the applicant's ‘notification of accreditation.’" The practice of conducting the site visit after accrediting a certifying agent contradicts the NOSB recommendation, (Santa Fe, June, 1994, Sligh, p. 20), which described a process whereby the evaluation occurred prior to accreditation. The proposed procedure also violates ISO Guide 61, section 2.3.1, which states, “The decision whether or not to accredit a body shall be taken on the basis of the information gathered during the accreditation process and any other relevant information. Those who make the accreditation decision shall not have participated in the audit.”
Accreditation should be granted after site evaluation, not before.
The peer review in section 205.509 is weak. As stated, “the Administrator may establish a peer review panel,” even though OFPA 6516(a) states “the Secretary shall consider a report concerning such applicant that shall be prepared by a peer review panel.” In addition, reviewers are required to act as individuals. This contradicts the OFPA citation above, which mentions a report from a peer review panel. By operating as individuals, peer reviewers are denied working in a collaborative process. Experience shows that collaboration often results in more comprehensive decisions than those achieved by individuals working in a vacuum.
The section also states “Peer reviewers will serve without compensation.” This is wholly inappropriate, and should be deleted. If the peer review process is to be taken seriously, panel members must be compensated for their expenses, and should be paid per diem.
The entire peer review section is disconnected from section 205.506 “approval of accreditation.” Peer review must be integral to the evaluation and approval process. That was the intent of Congress, as reflected in section 6516 of OFPA, which states that the peer review panel evaluates a State governing official or a private person seeking accreditation as a certifying agent. Peer review evaluation is also instrumental in the NOSB’s accreditation recommendation. (Santa Fe, June, 1994, Sligh, pp. 2-38). The role of peer review evaluation needs to be addressed in 205.506(a)(3), which discusses the “Administrator” determining approval of accreditation, with no mention of peer review.