Biotechnology Project
Center for Science in the Public Interest

May 3, 2001

By Fax and Regular Mail
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, R

Re: Comments on Docket Number 00N-1396, Premarket Notice Concerning Bioengineered Foods.

The Center for Science in the Public Interest ("CSPI")(1) submits these comments on the Food and Drug Administration’s ("FDA") proposed rule entitled "Premarket Notice Concerning Bioengineered Foods" ("PBN Rule").(2) The proposed PBN Rule, which we generally support, is a useful, though modest, improvement over the current voluntary consultation process. We urge FDA to make more sweeping changes in its regulations.

1.   A Mandatory Approval Process Will Safeguard the Food Supply and Bolster Public Confidence.

     FDA should review and approve the safety of every genetically engineered food before it is marketed. The public deserves a fair, transparent, mandatory premarket approval or certification process, including an opportunity for meaningful public input. Only a mandatory premarket approval process will maximally safeguard the food supply and bolster public confidence in the safety of genetically engineered foods. The proposed PBN Rule, which is a mandatory consultation process for all genetically engineered foods, will not inspire maximum public confidence in the safety of this powerful new technology.

     There are several reasons why FDA should institute a mandatory approval process for genetically engineered foods.(3) First, this is a relatively new technology for producing food and one cannot currently predict what products will be produced and whether they will be safe. In fact, FDA acknowledges throughout the proposed PBN Rule that genetic engineering is a special technique for producing foods that requires greater regulatory scrutiny than the current voluntary process.(4) Second, both USDA and EPA have mandatory approval processes before the genetically engineered plants that they regulate can be released into the environment. Those processes, which have formal opportunities for public input, attempt to protect our environment. Surely, all food, not just food with a pesticidal product, deserves a complete and open process to review the safety of that food. Third, the burden on industry from a mandatory approval process would be minimal. In most cases, developers must already ensure that their genetically engineered food is safe by conducting numerous scientific studies and tests. A mandatory approval process could be completed within a time period similar to the proposed PBN Rule. Fourth, a mandatory approval process would harmonize the safety review of genetically engineered foods in the U.S. with what occurs for identical foods introduced into commerce in Europe and other countries elsewhere around the globe. Finally, a mandatory stamp of approval from FDA for each genetically engineered food will significantly bolster public confidence, in the U.S. and abroad, in this technology and its products. Without mandatory approval, U.S. consumers might wonder why foreign governments, but not the U.S. government, review and approve genetically engineered foods.

     CSPI recommends that in a mandatory approval process, the testing and information requirements for genetically engineered food products should be based on their potential for causing harm. Specific factors that should be considered in deciding the testing and information requirements might include the characteristics of the donor species, the gene transferred into it, the organism of the transferred gene, whether the transferred gene came from a closely related species, whether the donor organism is a traditional food where the transferred gene is expressed in the consumed part of the donor plant, and whether the transferred gene is derived from a organism that is known to cause allergenic reactions.

     Finally, any mandatory approval system needs to be transparent and allow for involvement by the public. FDA should establish for every application to market a genetically engineered food a docket that contains all the non-confidential information in the application, all additional information received by the agency (whether from the company or other party), documentation of the substance of any telephone calls or meetings between FDA and the company or other parties, and all FDA documents pertaining to the food, including the agency’s final decision and related materials.(5) FDA should publish a Federal Register notice announcing the receipt of an application and provide ample opportunity for public comments to the agency well before its final decision. Upon completion of its review, FDA should publish a notice in the Federal Register announcing the agency’s final decision. The notice should summarize the agency’s finding, rationale, and supporting information.

     If FDA believes that it does not have the statutory authority to require a mandatory approval process for genetically engineered foods, it should seek such authority from Congress.

2.   Transparency of the PBN Process.

     CSPI supports all aspects of the proposed PBN Rule that make the information submitted by the developers and the agency review process available to the public in a transparent manner. In particular, CSPI supports the following provisions in the PBN Rule(6): (1) 21 CFR 192.10 © and (d), which state that most presubmission-consultations information would not be confidential and would be made available to the public; (2) 21 CFR 192.10(I), which states that FDA will establish an administrative file for the consultation and place specific materials in that file for public access; (3) 21 CFR 192.40, which sets forth the rules for disclosure of the PBN and FDA’s methods of providing the information to the public; (4) 21 CFR 192.20(b), which requires a redacted copy of any PBN submission that clearly identifies the location and approximate size of any information claimed as confidential; and (5) 21 CFR 192.40(e), which states that FDA will make easily available to the public the text of any letter issued by the agency under 192.30 © and the agency’s completed evaluation of the PBN. With those provisions in the final rule, the public would have increased confidence in FDA’s review process because it would have access to virtually all information in both the voluntary consultation and the PBN review process. That will enable anyone to independently evaluate both the data submitted and FDA’s analysis of that data.

     CSPI suggests several additional steps that should be considered in order to have a truly transparent process. First, section 192.10, which governs the proposed presubmission consultation process, includes specific regulations that establish an administrative file for the consultation ( 192.10(I)), yet there is no similar regulation for the PBN process ( 192.40 discusses public disclosure but does not discuss what would be in the administrative file). The PBN Rule should specify that an administrative file would be established that would include the PBN, any additional written materials or correspondence from the notifier, any correspondence from FDA to the notifier, documentation of any requests from FDA for additional information needed by FDA, and a memorandum of each meeting, e-mail, significant telephone call, or other communication between FDA and the notifier during FDA’s review process. Similar to the voluntary consultation process, the public should be provided with all documents transmitted between the notifier and FDA throughout the review process. Second, under the proposed PBN process, the public would have access to the PBN only when it has been filed by FDA. To have a truly transparent process, the public should have access to any initial PBN submission, even if it was deficient, and any documentation of what FDA has told the notifier is missing under Section 192.30(a)(2). Finally, as explained in more detail below, FDA should make available to the public the notifier’s justification of any confidentiality claim and FDA’s decision on those claims.

3.   Public Involvement in the PBN Process.

     Even if FDA does not propose a mandatory approval process, the proposed PBN Rule should invite the public to submit comments on the PBN at any point during the 120-day review process. FDA states in the preamble to the PBN Rule that the PBN process would ensure that "market entry decisions by the industry are made consistently and in full compliance with the law." Clearly, any relevant information from the public on this issue, such as scientific data on the allergenicity of a protein coded for by a particular transferred gene, would be helpful to FDA’s review of the genetically engineered food. FDA, in safeguarding the food supply, needs to review ALL relevant data about a particular genetically engineered food, not just information from the notifier. Therefore, FDA should allow for the submission of information by the public relevant to the FDA review of the genetically engineered food.

4.   Confidential Business Information Claims.

     CSPI appreciates the attempt by FDA to balance the rights of the public to obtain information in the hands of the government with the rights of a notifier to safeguard truly confidential business information. CSPI agrees with FDA’s statements that, in most cases, the fact that a notifier is consulting with FDA about a genetically engineered food and the PBN submissions would not be deemed confidential. As stated by FDA, most presubmission consultations and PBNs would occur subsequent to or simultaneously with approval processes at either USDA or EPA, both of which involve processes where some of the specifics about the genetically engineered food have already been made available to the public. In addition, CSPI agrees that it should be the burden of the notifier to explain why the consultation itself ( 192.10) or specific information in the PBN ( 192.25(a)(4)) should not be disclosed. CSPI recommends, however, that the final rule preamble state that general claims that information is a trade secret without specific substantiation would be rejected as inadequate and that any confidentiality claim must specifically address each particular piece of information being claimed confidential. Finally, CSPI agrees with the provisions of the PBN Rule that require the notifier to submit redacted versions of their submissions. That will allow the public access to as much information as is allowed by law.

     One issue that the current PBN Rule does not address, however, is public access to the notifier’s confidentiality claim and any FDA decision on that claim. That information (with redactions where necessary) should be made available to the public so that it could evaluate the validity of the notifier’s claim and analyze whether FDA had acted within the law. The public has certain rights under the Freedom of Information Act but it would be unable to ensure that those rights had not been compromised without access to the notifier’s explanation about why its information was confidential. Therefore, FDA should state in the final rule that if any information was deemed confidential, FDA would make available in the administrative file the notifier’s documents supporting its claim and FDA’s decision regarding that claim.

5.   Allergenicity of Genetically Engineered Foods.

     Several places in the PBN Rule address the allergenicity of genetically engineered foods. First, Section 192.25(f)(4) requires the PBN to include "a discussion of the available data or other information that address the potential that a protein introduced into the food will be an allergen." CSPI believes that that requirement is too general and that for foods containing genes from an organism that causes allergic reactions, either the petition should document that a gene that codes for an allergen was not incorporated into the engineered organism or thorough allergenicity testing should be required. Second, FDA states on page 14 of the preamble that even with appropriate labeling, certain genetically engineered foods containing an unexpected allergen would probably be considered adulterated within the meaning of section 402(a)(1) of the Act. CSPI urges FDA to state that all genetically engineered foods into which an allergen has been introduced are adulterated and prohibited from being marketed. CSPI can find no reason to allow on the market a genetically engineered food into which a new allergen has been introduced. Finally, FDA states that it is developing guidance for evaluating the potential allergenicity of proteins introduced into genetically engineered foods based on a conference held in 1994. A guidance document on this subject would be extremely useful. It should be based, however, on the most current scientific information about allergenicity, whether or not that information was presented at the FDA, EPA, and USDA joint conference in 1994. For example, FDA should review EPA’s recent (2000) SAP reports on allergenicity that modify, in some cases, the weight-of-evidence approach suggested by the 1994 conference.

6.   Data and Safety Testing Requirements for Genetically Engineered Foods

     In the proposed PBN Rule (and the current voluntary consultation process), FDA has not provided any details about what specific data and safety testing are needed for genetically engineered plants. While CSPI agrees with the need for a case-by-case evaluation of genetically engineered foods, detailed data and testing requirements are necessary for the PBN review. The currently used decision tree from 1992 provides a basis for the circumstances for when data may be needed but does not describe specific testing protocols. FDA should elaborate on the specific data and testing requirements, either in the regulations themselves, the preamble to the regulations, or in guidance that accompanies the regulations.

     Section 192.25 (f)(5), which is a catch-all provision for additional safety data on other classes of substances that might be introduced into a food, also needs additional elaboration. While FDA’s decision trees from 1992 and other guidance address the introduction of genes whose intended effect involves proteins, fats, carbohydrates, or micronutrients, there is no decision tree or guidance for other compounds, such as hormones, secondary metabolites, or the hundreds of other chemicals that might be engineered into a food. Many of these compounds have complex biological activity in humans and animals and scientists’ knowledge about their health effects, especially long term, is limited. FDA should elaborate on how genetically engineered products that effect secondary metabolites will be treated under the regulation and what data and testing will be required.

7.   Addressing Unintended Effects from Genetically Engineered Foods.

     In the preamble to the PBN Rule, FDA states that one reason for requiring a PBN is that it is more likely that future genetically engineered foods may have unintended effects, particularly from multiple gene introductions. It is unclear what FDA’s basis is for that demarcation between engineering of single and multiple genes. While multiple genes might have a higher probability of unintended effects, there is no reason to believe that a single gene would not alter metabolic pathways or cause mutations. FDA should ensure that it addresses unintended effects in all genetically engineered foods, not just multiple gene introductions. Similarly, the preamble states that rDNA and conventional breeding methods have a ". . . similar potential for unintended effects . . ." (pg. 18). While several papers and reports have discussed unintended effects resulting from rDNA and other methods of plant breeding, we are not aware of any attempts to determine whether the frequency of such effects is higher or lower in rDNA crops. If FDA is aware of such comparisons, it would be helpful to make them known. If such studies do not exist, it would be prudent, as suggested by the NAS in its 2000 report, to give significant scrutiny to the safety implications of unintended effects in all transgenic crops.

     The proposed regulations, as written, do not require any information from the notifier about unintended effects. Section 192.25 requires providing only toxicity and antinutrient information for naturally occurring known substances. FDA needs to set forth the types of testing that must be done to address unintended effects and when the different tests should be performed. In general, FDA should consider requiring whole-food toxicity testing for all genetically engineered foods where possible.(7) We urge FDA to commission an NAS study by toxicologists and allergists to recommend details of a tiered testing scheme.

8.   The FDA Response to a PBN ( 192.30 (d)).

     Section 192.30 (d), which addresses how FDA will respond to a PBN, needs to be strengthened and clarified. Sections 192.30 (d)(1) and (2) need to explicitly state that marketing of a genetically engineered food prior to FDA’s completion of a review is prohibited. The current language that FDA "expects" the food not to be marketed is ambiguous and may be unenforceable. In addition, when FDA determines that the PBN does not provide a basis for concluding that the genetically engineered food is safe or otherwise in compliance with applicable law ( 192.30 (d)(2)), FDA should be required to specify why it reached that conclusion.

     Section 192.30 (d)(3) should be revised to affirmatively approve the genetically engineered food as being as safe as its conventional counterpart. An affirmative statement would be much more helpful to the company and the public than a statement that the agency does not have any questions regarding the notifier’s view that the food is safe. At a minimum, however, FDA’s response to the notifier under 192.30 (d)(3) should set forth in detail the basis for FDA’s conclusion that it has no questions at this time.

     FDA should modify 192.30 (d) to add a fifth possible response to a PBN. That response option would state that "the agency has no questions regarding the notifier’s view that the genetically engineered food is safe but that the following conditions stated in this letter need to be met to comply with all applicable requirements." For example, if a genetically engineered food requires a different name (e.g. high oleic soybean oil) or a specific label statement, that condition should be specified in the final response from FDA to the notifier. That is particularly important because, in most cases, the notifier will be the developer of the genetically engineered food, not the manufacturer of the final food product that will be labeled and sold to the general public. Thus, any use conditions need to be specifically identified in the final letter so that all users of that food are aware of any conditions needed to comply with applicable law.

     Finally, the rule should clarify what happens if, after the 120-day review period, FDA responds that it is extending the evaluation for another 120 days as allowed by 192.30 (d)(1). At the end of the new 120-day period, could FDA again respond using 192.30 (d)(1) and get another 120-day extension or must FDA only choose among the other options in the regulations?

9.   Methods for Detecting Genetically Engineered Food.

     The PBN Rule should require that the PBN include methods by which the genetically engineered food could be detected. At a minimum, a testing method for the presence of the DNA of the transformation event and/or the protein from the introduced gene should be part of a PBN. PCR or ELISA are two detection methods currently available to the industry to develop the testing protocols for any PBN requirement.

10.   Split Approvals

     The PBN Rule, as currently written, would allow a genetically engineered food to be marketed for animals but not for humans. The StarLink corn problem this past year has demonstrated, however, that it can be difficult to segregate and prevent contamination from a food approved only for animal use but that is eaten by both humans and animals. Therefore, FDA should clearly state whether genetically engineered foods would be allowed for only animal use and under what conditions. Except for foods that are only eaten by animals (such as hay), CSPI believes that genetically engineered foods that humans might eat should not be marketed only for animals.

11.   Comments on Specific Sections of the Regulations.

     Definition of "Notifier," 192.1(c).

     Although the definition of "Notifier" states that it can be anyone responsible for development, distribution, importation or sale of the bioengineered food, the regulations are written as if the "notifier" is the developer. No one other than the developer would have the information required to be submitted in the PBN. In addition, if every manufacturer of a product that contained a genetically engineered ingredient was required to submit a PBN, FDA would receive far more than the 20 PBNs a year FDA predicted it would receive if the rule is finalized. CSPI agrees that the developer is the most appropriate person to submit the PBN. CSPI does not agree, however, with the discussion by FDA on page 40 of the preamble about the notifier’s responsibility to ensure that labeling of the food be appropriate as required by sections 201(n) and 403 of the Act. To the extent that an affirmative label is required for the genetically modified food (e.g., that the food is an allergen or that it should be called a specific name in the ingredient list), the developer should be responsible for proposing a proper label and conveying that information to the users of the particular food. The ultimate responsibility for the labeling of a food under the Act, however, should fall upon the manufacturer of the product that is sold to consumers. Therefore, the preamble should clarify that the company marketing a product to the consumer is ultimately responsible for an accurate label designation.

     The definition of "notifier" specifically includes an importer, yet nowhere in the preamble is there is an explicit statement that imported foods that contain genetically engineered ingredients are required to go through the PBN process. It is essential that imported foods that are genetically engineered undergo premarket review, and the rule should state this explicitly.

     Comment on 192.5.

     CSPI believes that the exemption from submitting a PBN set forth in 192.5 (a) should be modified to address situations where the level of expression of the intentionally modified trait may vary in different genetic backgrounds. If the level of expression of the intentionally modified trait is greater in a subsequent variety of the crop than the levels in the plant line that represents the transformation event that was reviewed by FDA, then the subsequent variety should not be exempted from submitting a PBN. These levels should be determined in the new varieties under the same growing conditions as were required for the original submission. The developers will likely have this information (at least on a phenotypic level) because it will have implications for crop properties.

     Additionally, there are insufficient data concerning similarities or differences in unexpected transgene effects on expression of indigenous genes in different varieties of the same crop to justify an exemption at this time. While similarities between varieties suggest that such effects should be more predictable than for separate transformation events, there is little data to support this contention. To the contrary, there are some data suggesting that transgenes may effect gene expression in different varieties of the same crop in dramatically different ways(8).

     On the other hand it would be impractical and unnecessary to require safety unique data for each new variety that a transgene is bred into by traditional means. Therefore, FDA should develop an intermediate policy of examining the first several such varieties under its criteria for establishing substantial equivalence, in order to ensure that possibly adverse unexpected changes have not occurred. If such testing of several varieties shows no adverse changes, or such changes become predictable based on these tests, no further varieties would need to be tested.

     Comment on 192.25(b).

     Section 192.25(b) requires a synopsis of the bioengineered food and is virtually identical to the Section 192.10(f)(3) synopsis suggested in a voluntary presubmission consultation. The preamble on page 42 states that the PBN synopsis should include the same information as the presubmission consultation. CSPI recommends that FDA make clear that the PBN synopsis required under section 192.25(b) should be the most complete and accurate information at the time of the submission and need not be identical to the information submitted in the presubmission consultation. In many instances, the presubmission consultation would require the notifier to collect additional information about the genetically engineered food and the results of the presubmission consultation should be reflected in the synopsis submitted in the PBN.

     Comment on 192.25 (d) (3).

     CSPI recommends that FDA specify additional information about the transformation event that must be provided. In particular, the submission should state whether the transformation occurs in the nuclear genome or an organellar genome (presumably chloroplast), the position of the gene insertions in the genome of the transformed plant and whether it is inserted in a gene, and what is the sequence of the added genetic material of the actual transformation event (as opposed to just the vector and gene(s) sequence prior to transformation). Genome or organelle location is important, in part, to assess the likelihood of possible contamination by pollen of surrounding crops (e.g., organic), since chloroplast transformation may greatly reduce or eliminate the likelihood of pollen contamination. The sequence of the transformation event is important because sequence changes can occur during transformation, and even single nucleotide or amino acid changes can result in functional changes in the resulting protein, such as changes in stability or allergenicity. It is also important to determine post-translational processing of proteins in characterizing the transformation event, especially if toxicity testing in animals is required. Sequencing of the transformation event may be routinely performed by currently available methods.

     Comment on 192.25 (e) and (f).

     In these sections, FDA requires information in the PBN on newly inserted genes that encode resistance to an antibiotic and on the potential that a protein introduced into the food will be an allergen. The regulations, however, state that the notifier contact FDA to find out what is the agency’s current view of what is necessary. Thus, these provisions are too vague and provide no basis for the public to determine if the PBN meets with FDA requirements. In our view, there is sufficient knowledge about these subjects to specify with more detail what is required in a PBN on these topics. For example, in vitro tests for properties correlated with food allergenicity are currently done for all genetically engineered foods and should be part of the PBN. At a minimum, however, if FDA will not specify what needs to be provided with the PBN in these regulations, they should write detailed written guidance that is public on these topics. Those guidance should include specific testing requirements based on the current state of the science and could be modified as the science and the agency’s thinking changes.

     Section 192.25(f) should also be modified to provide the notifier with guidance about the growth conditions, developmental states of the plant, and tissues of the crop that should be tested to determine the levels of expression. The levels of expression may vary considerably depending on those parameters.

     Finally, there is a consensus among scientists that genetically engineered foods can be developed for marketing without antibiotic-resistance genes. Thus, the preamble to the PBN Rule should discourage the use of antibiotic-resistance markers.

     Comment on 192.25(g).

     In order to select a comparable food and justify that selection, a notifier will usually need to make a selection among several different foods. To properly analyze whether the particular food selected is the correct one for the comparison, it would be helpful to FDA and the public to understand which foods were not selected as comparable and why. Therefore, FDA should specify in the rule that the justification of which particular food is selected for the comparison should include a discussion of what other similar foods were considered as comparable and why they were not selected.

     In 192.25 (g)(3), the regulations require comparing the bioengineered food with the whole food for levels of nutrients, toxicants, and antinutrients. CSPI believes that the comparison should involve not just the whole food but also compare the toxicants and antinutrients of the whole plant. Genes for toxicants and antinutrients that are not normally in the edible portion, but are found in other tissues of the plant, might be activated by the transformation event. Such toxicants, even if not consumed by people, might adversely affect animals and other creatures in the environment.

     Comment on 192.30

     As currently written, this regulation only allows FDA to identify missing information before the PBN has been filed. CSPI would assume that there would be situations in which FDA’s initial review of the PBN would suggest that it was complete, but that when FDA proceeded with its evaluation, it determined that either information was missing or additional information is needed. Therefore, this regulation should clarify that FDA has the authority to determine that the PBN is not complete and missing information at any time during the 120-day review period.

     Comment on 192.30(a) and (b).

     As stated above, FDA should make available to the public documentation of what is missing from a submitted PBN ( 192.30 (a)(2)) and the letter informing the notifier that the PBN has been filed.

12.   Transition to PBN Rule.

     For voluntary consultations that are pending on the date any final PBN Rule takes effect, the companies involved in those consultations should be required to submit a PBN and comply with the rule. The final rule should allow, however, that if the information provided to FDA under the voluntary consultation is identical to what is needed under the final rule, FDA will consider the existing submissions to be the PBN for that food. Requiring any pending consultation to submit a PBN should not be burdensome since most of the same information should have been submitted to FDA under the voluntary consultation. Submitting a PBN need not delay review of a genetically engineered food because if the consultation was almost complete, there is nothing in the PBN Rule that prevents FDA from expediting its review and sending its letter to the company in less than 120 days. In addition, for any voluntary consultations that occur between the publishing of a final rule and the effective date of that rule, FDA should make it clear that those submissions would be treated pursuant to the public access procedures set forth in Section 192.10.

     CSPI appreciates this opportunity to submit comments on the PBN Rule. CSPI understands that FDA has worked hard to address engineered foods under its statutory authority and hopes that in the coming months FDA seriously consider a mandatory approval process. If FDA would like additional information from CSPI about these comments, we would be happy to meet with you at your convenience.


Gregory Jaffe
Co-Director, Biotechnology Project
Center for Science in the Public Interest
202-332-9110, Ext. 369


1. CSPI is a nonprofit education and advocacy organization that focuses on improving the safety and nutritional quality of our food supply and on reducing the damage caused by alcoholic beverages. CSPI seeks to promote health through educating the public about nutrition and alcohol; it represents citizens’ interests before legislative, regulatory, and judicial bodies; and it works to ensure advances in science are used for the public good.CSPI is supported by the more than 900,000 member-subscribers to its Nutrition Action Healthletter, through foundation grants, and through sales of educational materials. CSPI receives no funding from industry or the federal government.

2. For the remainder of this comment, "PBN Rule" refers to the proposed rule and "PBN" refers to the premarket biotechnology notice required under Section 192.25.

3. FDA can institute a mandatory approval process based on the same statutory authority that legally supports the PBN Rule. These authorities include Sections 701(a), 301, 402, 403, and 409 of the Federal Food, Drug and Cosmetic Act.

4. Throughout the preamble to the PBN Rule, FDA discusses the need for additional scrutiny of genetically engineered foods. For example, on page 6, FDA acknowledges that "rDNA technology continues to evolve and it is not possible for the agency to anticipate all of the novel scientific and regulatory issues that may arise as the number and types of foods developed using this technology expands." FDA also states that there is a greater potential for these foods to contain substances that are food additives (pg. 12) and that with the increased introduction of multiple genes in future genetically engineered plants, "unintended effects may be more common." (pg. 16). Finally, FDA states that future genetically engineered crops will include not just agronomic changes to crops but modifications intended to change the food itself and "thus would be more likely than in the past to raise regulatory issues falling under FDA’s purview." (pg. 20). All of these observations by FDA about future genetically engineered plants support the need for a mandatory approval process to ensure a safe food supply.

5. The proposed rule is silent about what information other than the PBN that will be made public in the official docket for the mandatory review process whereas the proposed rule is specific about what will be made public for the voluntary consultation under 192.10. If FDA is going to include documentation of any meetings, all correspondence between FDA and the company or other parties, and all FDA documents pertaining to the food in a public docket, the final rule should state that.

6. Since proposed Sections 192 and 592 are identical in content, this comment letter will only refer to Section 192. However, all comments stated in this letter equally apply to Section 592.

7. CSPI recognizes that whole food testing is not always possible, such as when the food has poor nutritional or antinutritional qualities for the test animals. CSPI also recognizes that the results from such testing are not always useful since, for example, exaggerated exposure cannot usually be accomplished. However, until more information is available about unknown toxicants in crop plants, whole-food testing could be a useful insurance policy that could yield useful additional information to assess a food’s safety.

8. For example see M. Osusky et al. (2000) Transgenic plants expressing cationic peptide chimeras exhibit broad-spectrum resistance to phytopathogens. Nature Biotechnology, 18, 1162-1166. This paper does not involve transfer of a transgene between varieties by traditional breeding, but still address this issue because very different phenotypes resulted in the different varieties due to unexpected interactions between the transgene and genetic background independent of the transformation event.

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